Term Babies Research Articles

Maternal factors associated with early-onset neonatal sepsis among caesarean-delivered babies at Mbarara Regional Referral Hospital, Uganda: a case-control study

BackgroundBabies born via caesarean section in low-income settings face a higher risk of early-onset neonatal sepsis (EONS), which has greater mortality than late-onset sepsis. However, maternal factors contributing to EONS among caesarean-delivered babies in these settings, including Uganda, are not well documented. We determined maternal factors associated with EONS among term babies delivered by caesarian section at Mbarara Regional Referral Hospital (MRRH), southwestern Uganda.MethodsWe conducted an unmatched case-control study at MRRH from December 2019 to March 2020. Cases were caesarean section-delivered term babies with EONS (within 72 h). Controls were caesarean section-delivered term babies without EONS. We enrolled mother-baby pairs for both groups, obtaining maternal data via structured questionnaires The diagnosis of EONS was made using the WHO Young Infant Integrated Management of Childhood Illnesses algorithm. Cases were consecutively recruited while controls were recruited by simple random sampling in a ratio of 1:2. We excluded newborns whose mothers were too ill to consent. We used multivariable logistic regression analysis to identify maternal factors associated with EONS.ResultsWe enrolled 52 cases and 104 controls. The mean age for the mothers was 27 (± 5.5) years. Neonates born to referred mothers had higher odds of EONS than those born to non-referred mothers (AOR = 6.2, 95% CI: 1.8–21). Additionally, decision-to-delivery time > 1 h for emergency caesarean section (AOR = 16, 95% CI: 4.2–65), antepartum hemorrhage (AOR = 8.0, 95% CI: 1.6–40), primiparity (AOR = 4.8, 95% CI: 1.1–21), and > 3 vaginal examinations after membrane rupture (AOR = 4.3, 95% CI: 1.5–12) were associated with EONS.ConclusionsPrime gravidity, antepartum hemorrhage, multiple vaginal examinations after membrane rupture, long decision-to-delivery time, and referral status were associated with EONS among term babies delivered by caesarean section at MRRH. To reduce EONS risk, clinicians should limit post-membrane rupture vaginal exams or consider prophylactic antibiotics if multiple exams are needed. Screening babies born to primiparous women, those referred, those with antepartum hemorrhage, multiple vaginal exams after membranes rupture, and long decision-to-delivery times, could aid prompt recognition of EONS and timely interventions. Implementing standard procedures to reduce caesarean decision-to-delivery time could reduce risk for EONS in this setting.

Comparison of cord blood alarin levels of full-term infants according to birth weight.

To compare the cord blood alarin levels of infants in different birth weight groups with those of infantsborn to mothers diagnosed with gestational diabetes mellitus (GDM) who were not subgrouped according to birth weight. This prospective study was conducted between September 2023 and January 2024. Healthy term babies whose families agreed to participate in the study were divided into four groups according to their birth weight (small for gestational age (SGA), appropriate for gestational age (AGA) and large for gestational age (LGA)) and whether their mothers had GDM. There was a significant difference between the cord blood alarin levels of the AGA and SGA groups (p=0.014). There was also a significant difference between the cord blood alarin levels of the AGA and GDM groups (p=0.012). However, the cord blood alarin levels of the LGA group (whose mothers did not have GDM) were similar to those of the AGA group (p=0.394). We found evidence that alarin levels in umbilical cord blood are associated with low birth weight and GDM.

Predictive Value of Cord Blood Bilirubin for Hyperbilirubinemia in Term Neonates with ABO Incompatibility

Introduction: Jaundice affects 60% of full-term and 80% of preterm neonates. Feto-maternal ABO incompatibilities occur in 20-25% of pregnancies, but severe haemolytic disease develops in only 10%. ABO-incompatible babies have doubled the risk of jaundice requiring treatment and a 5-10 times increased risk of exchange transfusions. Objective: Aim of this study was to determine if cord blood bilirubin (CBB) can predict hyperbilirubinemia in term babies with ABO setup prior to discharge that would help to decrease readmission and subsequently complications due to jaundice. Methods: A hospital-based prospective observational study was conducted at Patan Hospital. Cord blood group and bilirubin levels were collected from newborns of O positive mothers. Babies with A positive and B positive blood groups had their CBB levels measured and were followed daily for 72 hours. Serum bilirubin was tested based on clinical judgment to detect hyperbilirubinemia and treated per NICE guidelines. Data were analysed using SPSS v21.0, Mann-Whitney test, ANOVA, and ROC analysis. Results: Among 66 cases, significant hyperbilirubinemia was seen in 7 neonates (10.6%). It was more common in B positive babies (12.2%) compared to A positive (8%). Mean CBB was 3.45 ± 0.57 in those developing significant hyperbilirubinemia. A CBB of 2.95 mg/dL had the highest sensitivity (86%), specificity (94%), and negative predictive value (98%) for predicting hyperbilirubinemia in ABO setup babies. Conclusion: Term babies with ABO incompatibility and CBB<2.95 mg /dL are unlikely to need further evaluation, while those with cord bilirubin level ≥2.95 mg/dL should have frequent early follow-ups.

Role of surfactant therapy in reducing oxygen requirement and mortality among neonates suffering from respiratory distress syndrome: A Prospective study at Al – Batool teaching hospital in Diyala province

Background: Respiratory distress syndrome (RDS) is a major cause of neonatal morbidity and mortality. It is a breathing disorder characterized by a deficiency or inactivity of surfactant in the lungs of preterm and term babies and if not treated, it leads to serious complications like pneumothorax, emphysema, bronchopulmonary dysplasia and death. Objective: To estimate the effect of surfactant therapy on oxygen requirement and neonatal mortality as well as the incidence of RDS in the special care neonatal unit (SCNU) in the AL Batool Teaching Hospital in Diyala Governorate. Patients and Methods: A sample of 2000 patients with signs and symptoms of RDS at the time of presentation was prospectively collected from the 1st of July 2022 until the 1st of March 2023 in SCNU at Al-Batool Teaching Hospital. Gestational age, body weight, the use of oxygen, surfactant therapy, and continuous positive airway pressure (CPAP) were taken into consideration in assessing the outcome of RDS neonates. Results: There was a significant relationship between surfactant administrations, the period of staying on CPAP, and oxygen demand as the p-value was < 0.001 for both. Neonates who received surfactant had a lower mortality rate, with an incidence of 2.5%; the p-value was < 0.001. Incidence of neonatal RDS was 694 (34.7%). Conclusion: Since the incidence of RDS was 34.7%, surfactant therapy should be routine in neonatal special and intensive care units. Proper use of surfactant (proper timing and mode of administration) reduces oxygen demand, the need for CPAP, hospitalization, and mortality among those neonates.

Study of the Evolution of a Cohort Of Low-Birth-Weight Newborns at Neonatal Discharge: A Perspective on Health and Sustainable Development Goals

Aims: This study aims to analyze the evolution of a cohort of low-birth-weight newborns at neonatal discharge, identifying key health outcomes and socio-economic factors. The goal is to inform strategies aligned with Sustainable Development Goal 3 (SDG 3), focusing on improving neonatal health, reducing child mortality, and promoting equitable access to healthcare. Method: A 12-month prospective cohort study was conducted from June 2020 to July 2021 at the neonatal and nutrition referral center of the Rabat children's hospital. The study included all newborns admitted with a birth weight under 2500g, regardless of the cause of hospitalization. Results: Among 200 low-birth-weight newborns, 42.5% showed extra-uterine growth retardation at discharge. Of these, 50.6% were full-term newborns and 36% were premature infants. Full-term newborns regained birth weight in an average of 5.96±4.07 days, with a median of 4 days. For premature infants, weight recovery averaged 11±8.09 days, with a median of 8 days. Conclusions: The study assessed the progress of low-birth-weight full-term and premature babies at discharge. Tailored nutritional management is crucial, requiring an adaptable strategy from the start and continued adjustments based on clinical progress. Of the cohort, 36.03% were hypotrophic premature infants, and 50.6% were full-term low-birth-weight babies. Enhancing neonatal care quality remains a key challenge, emphasizing the need for collaboration among healthcare professionals to ensure growth monitoring and meet the specific needs of this vulnerable group.

Comparison of different diagnostic methods in infants for differentiating idiopathic neonatal hepatitis from biliary atresia

Background: Biliary atresia (BA) and idiopathic neonatal hepatitis (INH) are two most common etiologies of neonatal cholestatic jaundice. It is important to distinguish INH from BA biliary atresia in an infant. The study was conducted to compare of different diagnostic methods in infants in differentiating INH and BA. Methods: This cross-sectional study was conducted at the Department of Pediatric Gastroenterology & Nutrition, BSMMU during the period from July 2018 to June 2019 among infants with neonatal cholestasis. Total 50 cholestatitic cases were selected through purposive sampling. A thorough history and physical examination were done and liver enzymes were studied. Abdominal ultrasonography, hepatobiliary scintigraphy and liver biopsy were done in all cases. Clinical parameter and investigational sensitivity, specificity, and diagnostic precision were calculated. To diagnose BA and INH, liver biopsy was considered the gold standard. Results: Among the participants, 72% were diagnosed as BA and 28% were INH. More than half of patients were male. There exists significant difference of birth weight and term baby between BA and INH. Presence of persistent pale coloured stool was more commonly seen in patients with BA. Diagnostic accuracy of persistent pale coloured stool, birth weight (normal) and term baby were 94%, 92% & 88% respectively. Sensitivity and specificity of Gammaglutamyl transpeptidase (GGT) in differentiating cases with BA and INH with cut point of ≥430.0 U/L were 86.1% and 85.7%, respectively. Hepatobiliary scintigraphy is found to have a better sensitivity than ultrasonography. GGT had diagnostic accuracy 86%, hepatobiliary scintigraphy had diagnostic accuracy 88% & USG had diagnostic accuracy 80% for BA and INH. Conclusion: Among the studied clinical parameters persistent pale coloured stool was most accurate to suggest the presence of BA. Serum level of GGT at cut-off value ≥ 430 U/L may be used as a reliable laboratory parameter to differentiate INH and BA. Hepatobiliary scintigraphy found to have a good sensitivity for BA. Positive result of hepatobiliary scintigraphy may be used as BA in infants with cholestasis. JOPSOM 2023; 42(1):14-20

EFFECT OF PHOTOTHERAPY ON SERUM CALCIUM AND MAGNESIUM LEVELS IN NEWBORNS WITH HYPERBILIRUBINEMIA ADMITTED TO NEONATAL INTENSIVE CARE AT A TERTIARY CARE TEACHING HOSPITAL IN THE KOLHAN REGION OF JHARKHAND

Objectives: Neonatal jaundice is a medical condition causing yellowish skin discoloration, leading to hospital readmissions in the first 2 weeks of life. It affects 60% of full-term babies and 80% of premature infants. Severe jaundice can cause kernicterus and neurological damage. Treatment options include phototherapy, exchange transfusions, or pharmacological therapy. Phototherapy is the safest and most effective treatment, but it can lead to hypocalcemia and hypomagnesemia due to its effect on the pineal gland. The present study shows the effect of phototherapy on serum calcium and magnesium levels in hyperbilirubinemia. Methods: A prospective observational study was conducted on 221 neonates with hyperbilirubinemia who were treated with phototherapy. We measured bilirubin, calcium, and magnesium levels in their blood samples at admission and 48 h after initiation of phototherapy. The data were analyzed using Epi-Info software. Results: Before phototherapy, the mean serum calcium was 8.79±1.44, but it decreased significantly to 8.13±1.67 (p<0.05). Before phototherapy, the mean serum magnesium level was 3.22±0.72 and reduced considerably to 2.56±0.50 (p<0.05). After phototherapy, total serum bilirubin levels reduced dramatically (from 13.07±3.41 to 8.63±3.10) (p<0.05). Conclusion: The present study shown that phototherapy has a significant effect on the levels of serum calcium, magnesium, and total serum bilirubin by reducing the level.

Exploring the potential cost-effectiveness of a new computerised decision support tool for identifying fetal compromise during monitored term labours: an early health economic model

BackgroundAround 60% of term labours in the UK are continuously monitored using cardiotocography (CTG) to guide clinical labour management. Interpreting the CTG trace is challenging, leading to some babies suffering adverse outcomes and others unnecessary expedited deliveries. A new data driven computerised tool combining multiple clinical risk factors with CTG data (attentive CTG) was developed to help identify term babies at risk of severe compromise during labour. This paper presents an early health economic model exploring its potential cost-effectiveness.MethodsThe model compared attentive CTG and usual care with usual care alone and simulated clinical events, healthcare costs, and infant quality-adjusted life years over 18 years. It was populated using data from a cohort of term pregnancies, the literature, and administrative datasets. Attentive CTG effectiveness was projected through improved monitoring sensitivity/specificity and potential reductions in numbers of severely compromised infants. Scenario analyses explored the impact of including litigation costs.ResultsNationally, attentive CTG could potentially avoid 10,000 unnecessary alerts in labour and 2400 emergency C-section deliveries through improved specificity. A reduction of 21 intrapartum stillbirths amongst severely compromised infants was also predicted with improved sensitivity. Attentive CTG could potentially lead to cost savings and health gains with a probability of being cost-effective at £25,000 per QALY ranging from 70 to 95%. Potential exists for further cost savings if litigation costs are included.ConclusionsAttentive CTG could offer a cost-effective use of healthcare resources. Prospective patient-level studies are needed to formally evaluate its effectiveness and economic impact in routine clinical practice.

Variation in NICU utilization: a narrative review and path forward.

Utilization of the Neonatal Intensive Care Unit (NICU) varies widely in the United States. Over recent decades, there has been a growth in NICUs, that varies by region, and has not been correlated to changes in demand or illness severity. Unnecessary NICU admissions are costly, stressful to families, may increase the risk of hospital acquired morbidities, and decrease breast feeding. Most of the variation in NICU utilization is based on the care of late preterm, early term, and term babies and is related to hospital level factors, including financial incentives, driving utilization. Improvement strategies to reduce variation include regionalization of care, certificate of need legislation, improving discharge processes, and caring for babies with some conditions such as Neonatal Opioid Withdrawal Syndrome or those with risk factors for sepsis outside of the NICU.

Vaccine hesitancy among parents of children in their first two years of life.

Vaccine hesitancy is considered a primary cause of outbreaks of vaccine-preventable infectious diseases. The Austrian vaccination plan includes 24 vaccinations in the first 2 years of life, 12 for free and 12 subject to a fee. Since preterm babies are more susceptible to severe infections, immunization is a vital protection strategy. This study examines the routine immunization schedule recommended for children in Austria, the number of timely vaccinations, and the number of delayed and rejected vaccinations. Possible reasons for vaccination delays and rejection and potential influencing factors (preterm birth, COVID-19 pandemic, information sources) are also analyzed. We included children aged 2 to 5 years who presented to Vienna's largest pediatric center with an Austrian mother-child pass and spent the first 2 years of their lives in Austria. Data was collected using questionnaires about the vaccination status, parents' reasons for any rejections or delays in the recommended vaccination regimen, the impact of the COVID-19 pandemic on individuals' vaccination behavior, and child-specific influencing factors such as preterm birth and socioeconomic factors. 90% of the 150 study subjects follow the recommendations on routine vaccinations, while 40-62% accept vaccinations subject to a fee. Preterm infants received less fee-based (53%) as well as gratuitous (88%) vaccinations. While free vaccinations tend to be delayed, more fee based vaccinations are rejected. With free vaccinations, delays and refusals occur due to illness or missed appointments. In the case of fee- required vaccinations, however, fears of side effects are also one of the main reasons. Due to the COVID-19 pandemic, about a quarter of parents have become more skeptical about vaccines. However, the vaccination rate of premature babies is usually just below that of full-term babies. Physicians remain the most trustworthy source of information about vaccinations. Free vaccinations are more accepted by parents than fee based vaccinations. Preterm babies, which are a high risk group for vaccination preventable diseases, show a lower or delayed vaccination rate, which must be prevented through intensive doctor education. In addition, vaccination hesitancy changed during the COVID-19 pandemic, which needs to be addressed during the medical consultation.

Evaluation of Etiological Causes and Demographic Characteristics of Neonatal Seizure in Adiyaman University Training And Research Hospital, Türkiye: A Retrospective Study

Aim: Neonatal seizures are different from seizures seen at other ages in terms of etiology, clinical follow-up, treatment and prognosis. The purpose of this study was to determine the etiological causes and demographic characteristics of neonates admitted due to seizures in the neonatal intensive care unit. Methods: This is an original study involving newborns hospitalized for seizures in the neonatal intensive care unit at Adıyaman University Training and Research Hospital. The files of 40 patients followed up due to seizures between September 2016 and July 2021, were examined retrospectively. 40 out of 45 patients satisfied the inclusion criteria. The files of 40 patients were retrospectively analyzed in terms of age, sex, gestational age, birth weight, mode of delivery, APGAR score, seizure etiology, intervention and treatment, electroencephalography (EEG), trans fontanel ultrasonography (USG) and brain magnetic resonance imaging (MRI) findings, length of hospital stay, and mortality rates. Results: The study group consisted of 40 patients, 21 girls (52.5%) and 19 boys (47.5%). Twenty-seven (67%) of the patient group were born at term and 13 (33%) preterm. The mean birth week was 38, and the mean birth weight was 2900 g. The underlying seizure etiology was unknown in 37.5% (n = 15) of cases, while the most common known etiological cause was hypoxic ischemic encephalopathy, seen in 20% (n = 8). The mortality rate in our patient group was 22.5% (n = 9). Conclusion: Among the known causes of neonatal convulsions, hypoxic-ischemic encephalopathy in term babies and germinal matrix bleeding in preterm babies were found to be the most common causes. However, despite all kinds of examinations and evaluations, the cause of a significant portion of them has not been determined. Long-term follow-up of newborns with convulsions is required to detect early neurodevelopmental problems that may develop during follow-up.

Investigation of the Diagnostic Value of Cerebrospinal Fluid and Serum sTREM-1 Levels in Neonatal Meningitis.

Background: The aim of this study is to investigate the diagnostic value of cerebrospinal fluid (CSF) and serum levels of the soluble form of triggering receptor-1 expressed on myeloid cells (sTREM-1) in neonatal meningitis. Methods: Serum sTREM-1 levels were measured in all neonatal sepsis patients at the start of antibiotic therapy and the 48th hour of treatment. At the beginning of antibiotic therapy, CSF samples were collected for sTREM-1 measurements. Control CSF samples were also collected from the patients with meningitis at the 48th hour of treatment. Results: A total of 77 preterm (50) and term (27) patients with neonatal sepsis were included in the study. There was no significant difference between the CSF sTREM-1 levels of patients with and without meningitis. The CSF sTREM-1 levels of preterm infants with meningitis decreased significantly after treatment (p = 0.038). Although the CSF/serum sTREM-1 ratios tended to increase in babies with meningitis, no significant difference was found between the groups. CSF/serum sTREM-1 ratios (mean ± SD) were 1.42 ± 0.91 and 1.14 ± 0.85 in preterm babies with and without meningitis and 1.15 ± 0.97 and 0.97 ± 0.55 in term babies with and without meningitis, respectively. Conclusions: Serum and CSF sTREM-1 levels increase in patients with neonatal sepsis. CSF s-TREM-1 levels decrease after treatment in preterm infants with meningitis.

Gestational DNA methylation age as a marker for fetal development and birth outcomes: findings from the Boston Birth Cohort

BackgroundGestational DNA methylation age (GAmAge) has been developed and validated in European ancestry samples. Its applicability to other ethnicities and associations with fetal stress and newborn phenotypes such as inflammation markers are still to be determined. This study aims to examine the applicability of GAmAge developed from cord blood samples of European decedents to a racially diverse birth cohort, and associations with newborn phenotypes.MethodsGAmAge based on 176 CpGs (Haftorn GAmAge) was calculated for 940 children from a US predominantly urban, low-income, multiethnic birth cohort. Cord blood DNA methylation was profiled by Illumina EPIC array. Newborn phenotypes included anthropometric measurements and, for a subset of newborns (N = 194), twenty-seven cord blood inflammatory markers (sandwich immunoassays).ResultsGAmAge had a stronger correlation with GEAA in boys (r = 0.89, 95% confidence interval (CI) [0.87,0.91]) compared with girls (r = 0.83, 95% CI [0.80,0.86]), and was stronger among extremely preterm to very preterm babies (r = 0.91, 95% CI [0.81,0.96]), compared with moderate (r = 0.48, 95% CI [0.34,0.60]) and term babies (r = 0.58, 95% CI [0.53,0.63]). Among White newborns (N = 51), the correlation between GAmAge vs. GEAA was slightly stronger (r = 0.89, 95% CI [0.82,0.94]) compared with Black/African American newborns (N = 668; r = 0.87, 95% CI [0.85,0.89]) or Hispanic (N = 221; r = 0.79, 95% CI [0.74,0.84]). Adjusting for GEAA and sex, GAmAge was associated with anthropometric measurements, cord blood brain-derived neurotrophic factor (BDNF), and monocyte chemoattractant protein-1 (MCP-1) (p < 0.05 for all).ConclusionsGAmAge estimation is robust across different populations and racial/ethnic subgroups. GAmAge may be utilized as a proxy for GEAA and for assessing fetus development, indicated by inflammatory state and birth outcomes.

Etiological Profile and Short-Term Outcomes of Acute Kidney Injury in Term Neonates at a Tertiary Care Centre in Western Maharashtra, India.

Background Acute kidney injury (AKI) is characterized by a sudden decline in kidney function, leading to a reduced glomerular filtration rate (GFR). This decline results in the accumulation of nitrogenous waste products in the blood, disturbs electrolyte balance, and disruptsfluid regulation. Objective To determine the etiological profile of AKI in term neonates. Methods Aprospective observational study was conducted at the Neonatal Intensive Care Unit (NICU) of our tertiary care hospital and referral and teaching center. The study spanned a period of two years, from August 2022 to July 2024, and comprised a total of 78 term babies diagnosed with AKI, all of whom were enrolled after obtaining consent using a predefined proforma. The neonatal period was defined as the time from birth up to 44 weeks of postmenstrual age (PMA), encompassing a critical developmental phase in newborns. Results In our study of 78 term neonates with AKI, we found a predominant occurrence in males (53, 67.9%) and a significant proportion with low birth weights (41, 52.6%). The most common cause of AKI was sepsis or multiple organ dysfunction syndrome (MODS) (32, 41%), followed by perinatal hypoxia (14, 17.9%) and urinary tract obstructions (12, 15.3%). Urinary tract infections (UTIs) accounted for nine cases (11.5%), hypernatremic dehydration for six cases (7.6%), acute tubular necrosis for three cases (3.8%), and congenital polycystic kidney disease for two cases (2.9%). Mortality was notably high, with 20 neonates (25.7%) dying from AKI, particularly those with sepsis/MODS and perinatal hypoxia. However, conditions such as urinary tract obstructions and UTIs generally had better outcomes. The statistical analysis revealed a significant association between the underlying etiology and outcomes (p<0.001), underscoring the importance of prompt and targeted interventions for different AKI causes in neonates. Conclusion Our findings highlight the diverse etiological spectrum of AKI in term neonates and its significant impact on mortality. Early recognition, appropriate management, and targeted interventions tailored to the underlying cause are crucial in improving outcomes for neonates with AKI.

Fatal Neonatal Influenza A Myocarditis.

A term baby underwent unexpected, fatal resuscitation in the delivery room. The mother suffered from a common cold during her last trimester of pregnancy. All other examinations throughout gestation were normal. Despite immediate, extended and effective resuscitation, heart rate did not exceed 15-20 beats/minute. In the autopsy, fetal myocarditis due to influenza A infection was detected.

Assessing the safety and efficacy of probiotics in improving the gut microbiome of premature infants

Introduction and PurposeThe gut microbiome is crucial to infant health and development. For premature infants, microbiome development differs from full-term babies, posing long-term health risks. Factors such as delivery method, feeding, antibiotic treatment, and neonatal intensive care unit (NICU) environment significantly influence the microbiome of premature infants. Probiotics, especially Bifidobacterium strains, show promise in enhancing health and reducing risks of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS).Material and MethodsThis review is based on articles from the PubMed database, covering the years 2004-2023, using keywords: gut microbiome, premature infants, probiotic, microbiome development, and neonatal intensive care unit.ResultsCurrent research indicates probiotics, particularly Bifidobacterium strains, positively impact the gut microbiome of premature infants, improving immunity and metabolism, and providing protection against NEC and LOS. Multi-strain probiotic preparations combining Bifidobacterium and Lactobacilaceae strains appear promising, but further research is needed to fully understand their effects. Addressing food intolerance (FI) in premature infants is another potential application of microbiome-focused therapies.ConclusionsWhile probiotics show promise in improving the microbiome of preterm infants, comprehensive research on single and multi-strain probiotics and their specific mechanisms of action is needed. Controversies persist regarding the safety, FDA regulation, and selection of specific probiotics and formulations. There is no consensus on the optimal timing for introducing probiotics. Further research is required to optimize probiotic selection and determine the best benefits. Enhanced standardization and oversight are essential to ensure safe and effective use of probiotics in neonatal healthcare.

Parameters of physical development of term newborns with Intrauterine Growth Retardation, born in a 3B Level Perinatal Centre of St. Petersburg State Pediatric Medical University in 2022

BACKGROUND: Intrauterine growth retardation of a newborn child is an current problem in neonatology, obstetrics and pediatrics. Due to intrauterine development disorders, these newborns have increased morbidity and mortality rates. In the presence of Intrauterine growth retardation, the likelihood of developing complications in the early neonatal period increases (birth asphyxia, meconium aspiration, hypoglycemia, polycythemia, etc.), and the risk of developing infections and neurological disorders) is increased. AIM: The aim of this study is to study the parameters of physical development of term newborns born in the Perinatal Centre 3B level of the St. Petersburg State Pediatric Medical University in 2022 year, to determine the frequency and structure of disorders associated with Intrauterine growth retardation and malnutrition depending on the gestational age of term newborns for a differential approach in the management of children with Intrauterine growth retardation by neonatologists and paediatricians. MATERIALS AND METHODS: There were analyzed 1000 hospital neonatal records of newborns children born at the Perinatal Centre of Level 3B of St. Petersburg State Pediatric Medical University in 2022 year. Of these, 55 term babies were born with Intrauterine growth retardation. The study examined the physical development of term newborns, determined the frequency and structure of disorders associated with intrauterine growth retardation and malnutrition, depending on the gestational age of term newborns. RESULTS: Retardation of intrauterine growth and development in newborn children born in level 3B centres are represented by low body weight in relation to gestational age in 63.6% of cases, trophic disorders with normal body weight and reduced weight/length ratio in 34.6% of cases, and low height index with normal body weight in 1.8% of cases. Severe physical developmental disorders were found only in children with low body weight: in 13% of cases of low birth weight for gestational age, and in 55% of cases of small fetal size for gestational age. CONCLUSIONS: the distribution of physical development disorders (ICD code P05.2) in term infants, depending on the degree of maturity has a linear trend and occurs with maximum frequency (50%) in late term newborns, which is associated with the onset of aging of the placenta and the intensification of existing, even compensated, placental insufficiency.

P-056 NOA-SERA: combined autologous progenitor cells and platelet-derived growth factors for male factor infertility due to non-obstructive azoospermia and severe oligoasthenoteratozoospermia (OATS) – a case series

Abstract Study question Can NOA-SERA be utilizing autologous progenitor cells and platelet-derived growth factors,effectively address male factor infertility in non-obstructive azoospermia (NOA) and severeoligoasthenoteratozoospermia (OATS) Summary answer Intra-testicular NOA-SERA transplantation of autologous progenitor cells andgrowth factors shows promise in improving spermatogenesis and fertilization potential,presenting potential breakthrough for male factor infertility. What is known already Male infertility affects 10–15% of couples, with non-obstructive azoospermia (NOA)diagnosed in 60% of azoospermic men. Current interventions, including platelet-rich plasma and stem cells, show variable success. This study introduces a novel protocol, NOA-SERA, combining autologous mobilized progenitor cells and platelet-derived growth factors to restore spermatogenesis. Despite advancements in assisted reproduction, male factor infertility due to primary NOA remains challenging. This case series explores the safety and efficacy of NOA-SERA, avoiding in vitro breeding risks and emphasizing intratesticular transplantation’s safety and efficacy Study design, size, duration his case series (March 2019–November 2023) includes 7 male factor infertility patients,consisting of 4 non-obstructive azoospermic NOA, 1 cryptozoospermia and 2 severe oligoaesthenoteratospermic (OATS, strongly desirous of pregnancy with self-gamete. All patients received NOA-SERA following written consent. One-year follow-up included hormonal profiling, semen analysis, and testicular biopsy assessment Participants/materials, setting, methods Seven men, with normal karyotype, underwent NOA-SERA due to male factor infertility. This intervention involved intra-testicular transplantation of autologous CD34+/CD133+ enriched peripheral blood mononuclear stem cells (MPB-MNCs) combined with platelet derived growth factors. The procedure, avoiding in vitro breeding and manipulation, prioritized safety and efficacy. Follow-up for one year included hormonal profile, semen analysis, testicular biopsy assessments, clinical pregnancy (b-hCG), sustained implantation (&amp;gt;8 weeks), and live birth rates were followed. Main results and the role of chance Analysis of NOA-SERA treatment in this case series revealed positive outcomes in 70% of patients, showing increased testicular size, elevated testosterone, and reduced FSH levels. In our study, out of 4 NOA, 2 NOA remained NOA, 1 progressed to OATS, 1 progressed to normal semen analysis after 3 months. Couple conceived with intrauterine insemination (IUI) first pregnancy and they also had a subsequent natural conception. 1 Crypto progressed to OATS and 1 severe OATS remained the same and one progressed to OATS. Although no appearance of sperm in the ejaculate was observed, 2 patients displayed sperms in Testicular Sperm Aspiration (TESA) sufficient for ICSI. Couples undergoing IVF therapy post-biopsy achieved successful fertilization in two cases, leading to positive pregnancies and sustained implantation and livebirth of healthy full-term babies. Post-procedure FSH was slightly lower than pre-procedural levels, indicating hormonal improvement without observed therapy-related deterioration. The novelty lies in the intratesticular transplantation of mobilized purified autologous CD34+/CD133+ enriched MPBMNCs with platelet-derived growth factors, avoiding in vitro risks.” To summarise, 3 out of 7 achieved successful pregnancy, 2 NOA with ICSI, 1 NOA progressed to normal semen analysis and pregnancy with IUI Limitations, reasons for caution Despite interesting results, limitations include the self-controlled case series design and asmall patient cohort, lacking a comparison to a control group. Future studies should include more patients, stratified for age, aetiology, and other risk factors, to further elucidate this intervention’s mechanism of action Wider implications of the findings NOA-SERA demonstrates promise in enhancing spermatogenesis and fertilization potential, emphasizing necessity for larger randomized trials to ascertain clinical efficacy, particularly in subgroups of OATS&amp;NOA patients. NOA-SERA emerges as safe, cost-effective adjuvant for optimizing spermatogenesis and improving IVF success and pregnancy outcomes in male factor infertility. Trial registration number Not applicable

P-329 Evaluating Implansera, autologous platelet-derived growth factors, to improve clinical pregnancy and live birth rates in frozen embryo transfer for women with recurrent implantation failure

Abstract Study question Can Implansera, Autologous Platelet-Derived Growth Factors, serve as a promising adjuvant therapy in assisted reproductive techniques to enhance endometrial thickness and implantation rates? Summary answer Use of Implansera significantly increased clinical pregnancy and Live Birth Rate In Patients With repeated implantation failure during FET cycles. What is known already Insufficient endometrial thickness and receptivity contribute to Recurrent Implantation Failure (RIF), prompting consideration of surrogacy. Despite global rise in Frozen Embryo Transfer (FET), quest for an optimal implantation protocol persists. Recent research highlights platelet-rich plasma (PRP) as promising solution for thin endometrium and RIF cases, attributing positive outcomes to PRP’s high growth factor concentration. Recognizing the need for precise platelet and growth factor concentrations, Implansera—a specialized platelet-derived growth factor concentrate—was developed. This innovation addresses the challenge of unresponsive endometrium, offering tailored solution to maximize therapeutic efficacy and improve pregnancy outcomes for patients facing RIF issues. Study design, size, duration Conducted from May 2021 to December 2023, this prospective interventional self-controlled study focused on 21 women (aged 30-48) experiencing recurrent IVF failure due to stubborn thin endometrium. Selected after negative hysteroscopic and bacteriologic screenings, and unsuccessful pregnancies despite multiple immune therapy regimens, such as intralipid and granulocyte colony-stimulating factor infusions, steroids, and endometrial scratching. The subjects underwent Implansera treatment, aiming to address refractory thin endometrium and potentially enhance their chances of successful conception. Participants/materials, setting, methods After obtaining informed consent women with at least two previous unexplained RIF, who were candidates for frozen-thawed embryo transfer were treated with intrauterine infusion of 0.8 ml of Implansera was infused into uterine cavity in addition to standard HRT protocols 2 days before ET. Clinical pregnancy was determined by positive serum β-HCG, 2weeks after ET and presence of fetal heart beat in trans-vaginal ultrasound 5weeks after ET. Main results and the role of chance Among 21 women, 10 achieved pregnancy (47.6%), while 11 did not conceive (52.4%). Clinical outcomes varied: 1 woman (4.8%) experienced chemical pregnancy, 3 (14.3%) miscarried before 6-12 weeks, 3 (14.3%) delivered healthy full-term babies, and 3 (14.3%) are in the 24th week of uneventful gestation accounts for 28.6% cumulative successful pregnancy outcomes. Implansera treatment yielded no reported adverse effects.Implansera, prepared through a patented proprietary process, standardized to contain 6-9 times higher growth factors than peripheral blood, particularly implantation-friendly and anti-inflammatory cytokines, addresses the crucial angiogenic and anti-inflammatory requirements for successful implantation. Tailored for the cyclical demands of endometrial proliferation, secretion, and implantation phases, it efficiently restores impaired uterine environments.Beyond efficacy, Implansera’s safety, reproducibility, and effectiveness in emulating natural tissue repair and regeneration processes are noteworthy. Studies underscore the significance of creating an environment conducive to successful implantation, and Implansera’s composition aligns with these requirements. Its capacity to mimic natural processes positions it as a promising solution, offering a comprehensive approach to enhancing endometrial receptivity, thus optimizing conditions for successful pregnancies. Limitations, reasons for caution This self-controlled prospective study, albeit with small sample size and lacking randomized control group, aligns with published data in demonstrating Implansera’s benefits. Proposing larger studies, particularly with unexplained RIF, to establish Implansera as routine IVF adjuvant. Further investigations aim to identify active molecules influencing implantation and suggest targeted recommendations. Wider implications of the findings Implansera improved implantation, pregnancy, and live birth rates (LBR) in unexplained RIF patients which indicates clearly endometrial thickness and receptivity improvement and motivated us to plan randomized controlled studies to confirm the results and provide opportunity for women with unexplained RIF to conceive and deliver in lesser number of cycles. Trial registration number Not applicable

P-801 Sub-endometrial administration of angiogenic precursor cells and growth factors effectively optimizes endometrial thickness (EMT) and pregnancy outcomes in women with refractory thin endometrium

Abstract Study question Can hysteroscopic instillation of autologous blood derived progenitor cells combined with platelet derived growth factor concentrate into subendometrial region help patient with thin endometrium conceive? Summary answer Hysteroscopic subendometrial administration of stem cells represents a safe effective alternative method for patients recommended surrogacy, fail to improve despite using all possible treatment options What is known already Chronically thin endometrium is a challenge in ART, results in repeated expensive IVF cycles, cycle cancellations, unplanned cryopreservation of embryos and, surrogacy. Many studies have successfully used stem cells or platelet derivatives to rejuvenate reproductive tissues. When these growth-promoting cells and growth factors from platelets are delivered into basal layer which is origin of endometrial cells quality of the endometrium can be improved. While bone marrow is excellent source for obtaining stem cells main challenge is invasiveness of collection. This forms the basis for collecting mobilized endothelial progenitor cells from bone marrow into circulation for easy collection Study design, size, duration This study is to evaluate effect angiogenic precursor cells and growth factors derived from peripheral blood and bone marrow in improving endometrial quality and pregnancy outcomes. In the present pilot study involving 87 patients with persistent refractory thin endometrium were included and underwent frozen embryo transfer from April 2021-January 2024 at A4 fertility center, Chennai. All patients were treated with peripheral blood derived progenitor cells and platelet derived growth factors. Participants/materials, setting, methods 87 patients with EMT&amp;lt;7mm and &amp;gt;2 cancelled/failed cycles included. Two doses of SC-G-CSF were given on Menstrual Cycle Day 3&amp;4, followed by venous blood aspiration on MCD-5. Seragen’s selective enrichment protocol was used to prepare circulating endothelial progenitor cells and growth factors concentrate. With 2.9mm hysteroscope and single lumen ovum pickup needle harvested cells and growth factors were injected on all four walls of cavity. Main results and the role of chance In this cohort, all patients presented refractory thin endometrium during hormone replacement therapy (HRT), despite exhaustive prior medication attempts. Subendometrial injection was employed, resulting in a significant increase in endometrial thickness (EMT) post peripheral blood cell injection (6.0 ± 0.71 vs. 7.80 ± 0.8; P = 0.0001), averaging a substantial improvement of 1.80mm. An optimal response, defined as EMT≥ 7mm, was observed in 47.2% (53) of cases. Patients with improved thickness underwent embryo transfer in the subsequent cycle, displaying a significant enhancement in endometrial thickness. Out of 53 patients, 47.2% (25) tested positive for β-HCG, while 45.3% (24) tested negative. Miscarriage occurred in 9.4% (5) of patients, with 8.8% (3) delivering healthy full-term babies. Notably, 28.3% (15) sustained uneventful pregnancies, accounting for a 34% sustained implantation rate. Comparatively, when benchmarked against subendometrial platelet-rich plasma (PRP) studies, primary and secondary outcomes in our study demonstrated superiority. This favorable outcome is attributed to the combined utilization of mobilized progenitor cells and growth factors. Prior research has established that the endometrium derives its stem cell content from the bone marrow, underscoring the efficacy of this novel approach. Limitations, reasons for caution Future research should explore avenues for women with refractory thin endometrium, offering conception options without resorting to surrogacy. Clinician expertise in patientselection, personalized dosage, and administration is crucial. While our study offers promising insights, its limitations include small sample size and lack of randomization, emphasizing need for larger, controlled trials. Wider implications of the findings Our study reveals that combine use of growth factors progenitor cells enhances endometrial thickness and improves pregnancy and live birth rates. Re-evaluating need for surrogacy in nonresponsive thin endometrium may be warranted. Insights from hematopoietic stem cell research offer reliable strategy for routine use in IVF clinical practice. Trial registration number Not applicable