Extremely Low Birth Weight Infants Research Articles

Effect of hospital nutrition program on growth of very low birth weight preterm babies.

Objective: To determine the effect of hospital nutrition program on growth of very low birth weight (VLBW) and extremely low birth weight (ELBW) babies. Study Design: Cross-sectional study. Setting: Neonatal Intensive Care Unit (NICU) of Recep Tayyep Erdogan Hospital, Muzaffargarh, Pakistan. Period: February 2024 to July 2024. Methods: Inclusion criteria were preterm newborns weighing below 1500 grams, admitted in NICU and who received total parenteral nutrition (TPN). VLBW was labeled as birth weight between 1000-1499 grams, while ELBW as birth weight <1000 grams. Hospital nutrition program included TPN plus orogastric feed or nasogastric feeding plus micronutrients. Effect of hospital nutrition program was described as effective if the baby at the time of discharge added 17-20 g/kg/day according to ESPHGAN recommendation. Results: In a total of 131 newborns, 69 (52.7%) were boys. The mean gestational age, and birth weight were 29.68±1.87 weeks, and 1024.50±144.23 grams, respectively. The mean net daily weight gain at the time of discharge was 12.77±3.63 grams. The effective hospital nutrition program was noted in 23 (17.6%) babies. Effectiveness of hospital nutrition program was significantly associated with higher birth weight (1094.78±114.41 vs. 1009.54±145.93 grams, p=0.010), very low birth weight versus extremely low birth weight (87.0% vs. 13.0%, p<0.001), head circumference ≥30 cm (87.0% vs. 53.7%, p=0.003), and gestational age > 28 weeks (87.0% vs. 57.4%, p=0.008). Conclusion: The hospital nutrition program had limited effectiveness, with only 17.6% of VLBW and ELBW infants achieving the recommended weight gain by discharge.

A Moving Target: Studying the Effect of Continuous Transcutaneous CO2 Monitoring in ELBW Infants During an Equipoise Shift

Objectives: To assess whether continuous non-invasive pCO2 monitoring by transcutaneous pCO2 monitor (TCpCO2) among extremely low birth weight (ELBW) premature infants, during the first week of life, will decrease the rate of high-grade intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL) or the combined outcome of IVH/PVL and death. Methods: This was a prospective, observational, multicenter study. Due to ethical constraints, allocation was based on TCpCO2 monitor availability. ELBW infants were either monitored by TCpCO2 monitor (Sentec, Therwil, Switzerland) (study group), or recruited to the control group if a TCpCO2 monitor was not available. Results: A total of 32 ELBW infants participated in the study. The size of the study group (106 infants) and the control group (26 infants) differed because monitor availability increased during the study period reflecting change in standard of care. The groups had comparable gestational age and baseline characteristics. No difference was found in the rate of IVH/PVL in the study vs. control groups (10% vs. 4%; p = 0.7, respectively), or in the combined outcome of PVL/IVH and death (16% vs. 15%; p = 1.0, respectively). Conclusions: This study demonstrates the challenges in conducting a prospective controlled trial in a rapidly evolving medical field. While the study began with a clear equipoise, this balance shifted as the care team gained more experience with TCpCO2 monitoring among the study population, despite the absence of new clinical evidence to justify such a shift. Consequently, the small control group limited our ability to draw definitive conclusions regarding the study’s objective. However, our findings may increase awareness of continuous non-invasive pCO2 monitoring in extremely premature infants.

Usefulness of apparent diffusion coefficient values for assessment of MRI abnormality at term equivalent age in low-birth-weight infants weighing less than 1500g.

To determine whether apparent diffusion coefficient (ADC) measurements at term equivalent age (TEA) are useful for assessment of major abnormalities revealed by MRI. Of 405 neonates who underwent MRI during the period 2016-2022, 101 low birth weight (LBW) infants (birth weight < 1500g) were imaged at TEA. ADC values were measured in the thalamus, basal ganglia, anterior and posterior centrum semiovale, pons, and cerebellar hemisphere. The ADC values in LBW infants with and without major abnormalities evident on MRI were compared at the above six sites. Abnormal findings included IVH-3 IVH-4, more than six punctate white matter lesion, white matter injury (cystic or non-cystic), and major cerebellar hemorrhage. LBW infants overall (N = 101) and an extreme LBW (ELBW) group (< 1000g) (N = 55) were compared and area under the curve was calculated using ROC analysis. There were no difference in ADC values between LBW infants with and without major abnormalities. In ELBW infants, ADC values in the cerebellum were higher when major abnormalities were present (p = 0.045). ROC analysis yielded AUC < 0.7 for both LBW cases overall and ELBW cases. For LBW infants overall, ADC measurements alone at TEA are not very useful for differentiation between individuals with and without major abnormalities, but ELBW infants with major abnormalitiesshowed higher ADC values in the cerebellum, suggesting that the normal reduction of ADC occurring with maturation between preterm birth and TEA may be impaired.

Recommendations for antibiotic use in hospitalized preterm infants with late-onset sepsis in the neonatal intensive care unit

Late-onset sepsis (LOS) is commonly seen in neonates who are hospitalized for extended periods, particularly in very low birth weight infants (VLBWI) and extremely low birth weight infants (ELBWI). Currently, the management of LOS in preterm infants faces dual challenges of delayed diagnosis and treatment, as well as antibiotic overtreatment. To address these issues, the Hunan Neonatal Medical Quality Control Center and the Neonatology Group of Perinatal Medical Committee of Hunan Medical Association organized a group of neonatal experts from Hunan Province to formulate recommendations based on published literature and statistical data from the Hunan Neonatal Medical Quality Control Center, as well as real-world practices in most neonatal intensive care units in Hunan Province. The group of neonatal experts proposed 15 recommendations for the diagnosis and antibiotic treatment of LOS in hospitalized preterm infants in the neonatal intensive care unit.

Management of gastroschisis in an extremely low birth weight infant: report of a case

BackgroundGastroschisis is a rare congenital anomaly in which abdominal organs herniate through a defect in the abdominal wall. Managing gastroschisis in extremely low birth weight (ELBW) infants presents significant challenges because of their immature physiologies and increased risk of complications.Case presentation: This report discusses the case of a female ELBW infant born via an emergency cesarean section at 29 weeks of gestation, weighing 768 g, who had a prenatal diagnosis of gastroschisis. Postnatal management included immediate surgical intervention using a hand-made silo manufactured from expanded polytetrafluoroethylene (ePTFE) sheets that were sutured to the patient’s abdominal wall to accommodate her small abdominal cavity and preserve mesenteric blood flow. Necrotizing enterocolitis with bowel perforation emerged as a complication, which led to the excision of a 10 cm segment of the ileum and the creation of an ileostomy. The infant experienced insufficient weight gain and liver dysfunction. However, she was eventually discharged on day 142 of life, weighing 2774 g, on oral feeding, without significant complications.ConclusionsThis case emphasizes how prematurity significantly affected the patient’s clinical outcomes, and highlights the importance of individualized management strategies. Our experience demonstrates that custom silo placement allows for the size to be adapted to the abdominal defect, and highlights the critical need to prioritize postnatal bowel perfusion in ELBW infants with gastroschisis.

Non-Invasive Ventilation with Neurally Adjusted Ventilatory Assist (NAVA) Improves Extubation Outcomes in Extremely Low-Birth-Weight Infants.

Objective: This study investigates the effectiveness of extubation from conventional mechanical ventilation using an endotracheal tube (MVET) compared to synchronized non-invasive positive-pressure ventilation (sNIPPV) using neurally adjusted ventilatory assist (NAVA) and conventional non-invasive positive-pressure ventilation (NIPPV) in extremely low-birth-weight (ELBW) infants. Methods: An institutional review board (IRB) approved this study (#12175) to conduct a single-center randomized control trial including 60 ELBW infants assigned in a one-to-one computer-generated scheme to either sNIPPV using NAVA or NIPPV. The primary outcome involved the need for reintubation, and the secondary outcome involved the assessment of moderate/severe BPD, defined as an oxygen requirement at 36 weeks, as in #NCT03613987 (clinicaltrials.gov). Results: There were 60 ELBW infants enrolled and randomized. The overall gestational age was 26 (1.5) weeks, and the birth weight was 773 (157) g [mean (SD)]. There were no statistically significant differences between the NAVA and NIPPV patient characteristics. There was a 41% extubation failure rate in the NIPPV group and 35% in the NAVA group (p = NS). The NAVA group had less moderate and severe BPD (p = 0.03), a shorter oxygen therapy duration (p = 0.002), a decreased length of stay (p = 0.03), and less need for home oxygen (0, 43%; p = 0.0004). Conclusions: This study found similar extubation failure rates among ELBW infants as in prior studies. However, the NAVA group had lower rates of moderate/severe BPD and need for oxygen at discharge, as well as shorter oxygen therapy duration and length of stay. The use of NAVA may be a reasonable alternative mode of non-invasive ventilation in the ELBW population.

Image Quality of Cardiac Silicon Photomultiplier PET/CT Using an Infant Phantom of Extremely Low Birth Weight.

The lack of pediatrics-specific equipment for nuclear medicine imaging has resulted in insufficient diagnostic information for newborns, especially low-birth-weight infants. Although PET offers high spatial resolution and low radiation exposure, its use in newborns is limited. This study investigated the feasibility of cardiac PET imaging using the latest silicon photomultiplier (SiPM) PET technology in infants of extremely low birth weight (ELBW) using a phantom model. Methods: The study used a phantom model representing a 500-g ELBW infant with brain, cardiac, liver, and lung tissues. The cardiac tissue included a 3-mm-thick defect mimicking myocardial infarction. Organ tracer concentrations were calculated assuming 18F-FDG myocardial viability scans and 18F-flurpiridaz myocardial perfusion scans and were added to the phantom organs. Imaging was performed using an SiPM PET/CT scanner with a 5-min acquisition. The data acquired in list mode were reconstructed using 3-dimensional ordered-subsets expectation maximization with varying iterations. Image evaluation was based on the depiction of the myocardial defect compared with normal myocardial accumulation. Results: Increasing the number of iterations improved the contrast of the myocardial defect for both tracers, with 18F-flurpiridaz showing higher contrast than 18F-FDG. However, even at 50 iterations, both tracers overestimated the defect accumulation. A bull's-eye image can display the flow metabolism mismatch using images from both tracers. Conclusion: SiPM PET enabled cardiac PET imaging in a 500-g ELBW phantom with a 1-g heart. However, there were limitations in adequately depicting these defects. Considering the image quality and defect contrast,18F-flurpiridaz appears more desirable than 18F-FDG if only one of the two can be used.

Cord blood utilization as a blood conservation measure in the neonatal intensive care unit

Extremely low birth weight (ELBW) and very low birth weight (VLBW) infants are often exposed to several laboratory blood draws throughout their neonatal intensive care unit (NICU) stay, particularly at admission. Required routine admission labs place patients at risk for iatrogenic blood loss and need for treatment. Studies have demonstrated that blood collected from an umbilical cord segment may be used to obtain admission labs rather than drawing blood directly from the patient. The purpose of the quality improvement (QI) project was to determine if the utilization of umbilical cord blood for routine admission labs compared to the standard practice of infant phlebotamization result in fewer cases of iatrogenic anemia and the need for treatment in ELBW and VLBW infants. The following outcomes were monitored pre/post-implementation: number of blood transfusions, intra-ventricular hemorrhage (IVH) diagnosis, IVH severity, and vasopressor use. Despite a small sample size, statistically significant results were obtained.

EPIDEMIOLOGY OF RESPIRATORY DISTRESS IN PRETERM NEWBORNS ADMITTED WITH RESPIRATORY DISTRESS IN NICU: A CROSS SECTIONAL STUDY

Background:Respiratory distress is one of the most common cause of newborns admitting to NICUs. The objective of this cross-sectional study was to examine the epidemiological profile of preterm neonates with respiratory distress in the NICU. It was carried out from August 2023 to July 2024 at Akash institute of medical sciences and research centre, Devanahalli, Bengaluru Rural. Materials and Methods: This cross-sectional study included 42 neonates under the age of 28 days. Respiratory distress was diagnosed using specific criteria, and detailed clinical assessments were performed to confirm the aetiology. Data on demographics, risk factors, and therapeutic modalities were collected and analysed using SPSS version 25. Results: A total number of 81 neonates are admitted in NICU for respiratory distress, 42 cases were preterm. In those preterm ,late preterm babies 33(79%) had respiratory distress, followed by moderate preterm 5(12%). Males, 23(54.76%) were more prone for respiratory distress compared to females, 19 (45.24%). LSCS ,34 (80.95%)was the major cause for respiratory distress. All cases required oxygen supportbut oxygen prongs was given to 23(54.76%) cases, CPAP was given to 16 (38.05%) cases, 3(7.14%) were mechanically ventilated. Low birth weight infants,24(57%) weremore prone for respiratory distress compared to very low birth weight 11(26%) and extreme low birth weight infants 1 (3%). 15 (35.71%) cases were not having any risk factors but 9 (21.42%) had PIH. TTNB, in 19(45.23%) cases was the most common aetiology for causing respiratory distress. Conclusion: This study underscores the necessity for heightened awareness and specialized care protocols for preterm neonates, particularly those born via LSCS and those with low birth weight, to mitigate the risks and improve outcomes associated with respiratory distress.

Adjusted versus Targeted Fortification in Extremely Low Birth Weight Preterm Infants: Fortin Study-A Randomized Clinical Trial.

Fortified human milk is the first choice for preterm infants. Although individualized fortification is recommended, the optimal method for this population remains uncertain. We conducted a comparative study assessing the growth effects of adjusted (AF) and targeted fortification (TF) in extremely low birth weight (ELBW) infants. This single-center, randomized, controlled clinical trial was conducted at a tertiary neonatal unit in Spain. Eligible participants were premature infants with a birthweight of <1000 g exclusively fed with human milk. A total of 38 patients were enrolled, 15 of them randomized to AF group and 23 to TF group. AF was based on blood urea nitrogen (BUN) concentration and TF on human milk analysis. The primary outcome was weight gain velocity (g/kg/day). No significant differences were found in weight gain velocity at 28 days, at 36 weeks of postmenstrual age, at discharge, nor during the intervention. Protein intake was significantly higher in the AF group (5.02 g/kg/day vs. 4.48 g/kg/day, p = 0.001). No differences were found in the lipid, carbohydrate, and energy intake; in the weight z score change between the different time points; nor in the length and head circumference growth. Both AF and TF are comparable methods of fortification and provide the appropriate growth rate in ELBW infants.

Perinatal risk factors of renal outcome in former extremely low birth weight neonates

Former Extremely Low Birthweight (ELBW) neonates suffer from adverse renal and cardiovascular outcomes later in life. Less is known about additional perinatal risk factors for these adverse outcomes which we have investigated in this study. We compared renal outcome between ELBW children and controls, to find perinatal risk factors for poorer renal outcome and to unveil associations between kidney function and blood pressure. This study included 93 former ELBW children and 87 healthy controls with a mean age of 11 years at assessment. We measured cystatin C-based estimated glomerular filtration rate (eGFR) and blood pressure. Blood pressure and eGFR levels were compared between cases and controls. We subsequently investigated perinatal risk factors for adverse outcome amongst ELBW children. ELBW children have significantly higher blood pressure (mean SBP percentile 75thvs. 47th, p <0.001) and lower mean eGFR (94 vs. 107 ml/min/1.73 m2, p = 0.005) compared to the control group. Elevated blood pressure did not correlate with perinatal characteristics and none of them had microalbuminuria. ELBW children with eGFR <90 ml/min/1.73 m2 were ventilated longer (17 vs. 9 days, p = 0.006), more frequently male (OR = 3.33, p = 0.055) and tended to suffer more from intraventricular hemorrhage (40% vs. 15.8%, p = 0.056). There was no association between blood pressure and kidney dysfunction. Conclusions: Understanding risk profiles for unfavorable outcomes may help to identify children at increased risk for kidney dysfunction. Poorer eGFR was associated with longer ventilation, male sex, and intra-ventricular hemorrhage but not with blood pressure. This knowledge can lead to safer neonatal therapeutic regimens for ELBW infants, a more intensive follow-up and earlier treatment initiation for children at highest risk. What is Known:• Extremely Low Birthweight (ELBW) neonates suffer later in life from adverse renal and cardiovascular outcomes.• Perinatal risk factors that further predict the individual risk for adverse outcomes are not well known.What is New:• Poorer eGFR in adolescence was associated with male sex, longer ventilation and intra-ventricular hemorrhage at birth but not with blood pressure.• Former ELBW infants had higher blood pressures compared to controls, but no microalbuminuria.• This knowledge can lead to potential precision medicine, safer neonatal therapeutic regimens for ELBW infants, a more intensive follow-up and earlier treatment initiation for children at highest risk.

Impact of the Choice of Diagnostic Criteria and Growth Reference on the Prevalence of Extrauterine Growth Restriction in Extremely-Low-Birthweight Infants.

Variable diagnostic criteria and growth charts have been used for extrauterine growth restriction (EUGR). The objective was to assess the prevalence and concordance of EUGR in extremely-low-birthweight (ELBW) infants with the most frequent diagnostic criteria and growth charts. An observational, retrospective and multicenter study was conducted from 2011 to 2020 including ELBW infants from the Spanish SEN1500 Network. EUGR prevalence was calculated at discharge using different definitions: cross-sectional (anthropometry less than the 10th centile), longitudinal (decrease of more than 1 SD from birth to discharge), "true" cross-sectional and "true" longitudinal (using the criteria previously described, excluding infants small for gestational age at birth). Concordance among Fenton, Olsen and INTERGROWTH-21st was assessed with Fleiss' Kappa coefficient. The prevalence of EUGR was variable with the different definitions and growth references studied in the 7914 ELBW infants included. Overall, it was higher with Fenton for all the EUGR criteria studied by weight and length. The agreement among growth charts was substantial (κ > 0.6) for all the definitions except for longitudinal EUGR by weight (moderate, κ = 0.578). The prevalence of EUGR was variable in our cohort with the different diagnostic criteria and growth charts. The agreement among charts was good for all the definitions of EUGR except longitudinal EUGR by weight.

Initial surgery for spontaneous intestinal perforation in extremely low birth weight infants is not associated with mortality or in-hospital morbidities.

Determine short-term outcomes following peritoneal drain (PD), laparotomy (LAP) after PD (PD-LAP), and LAP in extremely low birth weight (ELBW) infants with spontaneous intestinal perforation (SIP). ELBW infants with SIP were identified using the Children's Hospitals Neonatal Database. Mortality and length of stay (LOS) were compared among groups. Of 729 SIP infants from 6/2010-12/2016, 383(53%) received PD, 61(8%) PD-LAP, and 285(39%) LAP. PD infants had lower GA at birth, at SIP diagnosis and upon admission than PD-LAP or LAP; and higher sepsis rates than LAP. Bivariate analysis and Kaplan-Meier survival estimates suggested PD had increased mortality vs. PD-LAP and LAP (27%, 11.5%, and 15.8% respectively, p < 0.001). However, surgical approach was not significantly associated with mortality in multivariable analysis accounting for GA and illness severity. LOS did not differ by surgical approach. In ELBW infants with SIP, mortality, and LOS are independent of the initial surgical approach.

Implementation Rate of Physical Rehabilitation in Neonatal Intensive Care Units in Japan: A Retrospective Observational Study.

Background and Objective: The benefits of physical rehabilitation for very-low-birth-weight infants (VLBWI) have been reported in previous studies; however, the implementation rate of physical rehabilitation in this population remains to be clarified. This study aimed to examine the implementation rate of physical rehabilitation among VLBWI admitted to the neonatal intensive care unit (NICU) using real-world data. Material and Methods: This observational study obtained data from a nationwide administrative database associated with the diagnostic procedure combination (DPC) system in Japan (2014-2019). The participants were 30,464 infants admitted to the NICU between 2014 and 2019. The overall NICU physical rehabilitation rates and background factors of the participants were examined. Results: The overall physical rehabilitation rate in NICUs was 18%. Infants born at <28 weeks of age and extremely low birth weight infants (ELBWI) were more likely to receive physical rehabilitation interventions. The length of stay at the NICU and hospital, as well as the rate of discharge, were higher in patients who received physical rehabilitation than those in infants who did not. Conclusions: One-fifth of all patients admitted to the NICU received physical rehabilitation interventions. Extremely preterm infants and ELBWI were more likely to receive physical rehabilitation interventions. We need to consider ways to increase physical rehabilitation intervention rates in the NICU.

Association of different doses of antenatal corticosteroids exposure with early major outcomes and early weight loss percentage in extremely preterm infants or extremely low birthweight infants: a multicentre cohort study

ObjectivesTo determine the dose-dependent associations between antenatal corticosteroids (ANS) exposure and the rates of major morbidities, and the early weight loss percentage (EWLP) in hospital among extremely preterm infants (EPI)...

Enteral Feedings Do Not Increase the Risk of NEC in ELBW Infants Undergoing Treatment of Patent Ductus Arteriosus With Acetaminophen.

Acetaminophen (APAP) is an alternative to indomethacin and ibuprofen for treatment of patent ductus arteriosus (PDA). The side effect profile of non-steroidal anti-inflammatory drugs (NSAIDs) presents enteral feeding safety concerns; however, the safety of enteral feeding on APAP is largely unknown. Optimal feeding strategies during pharmacological PDA treatment are unknown, leading to practice variation. This study aims to assess the incidence of adverse gastrointestinal (GI) outcomes in neonates treated with APAP for PDA closure while receiving enteral feedings. Single-center retrospective cohort study of 59 extremely low birth weight (ELBW), premature neonates who received APAP for PDA treatment divided into Low Volume (LV; ≤ 20 mL/kg/day) and High Volume (HV; > 20 mL/kg/day) enteral feeding groups. The primary outcome was the incidence of any suspected or confirmed necrotizing enterocolitis (NEC). Timing of nutrition milestones, parenteral nutrition (PN) days, and adverse outcomes (feeding intolerance, liver dysfunction, death prior to discharge) were evaluated. The incidence of suspected or confirmed NEC was 19.5% in the LV group and 13.3% in the HV group (p = 0.593). The HV group reached full feeds 6 days sooner (18 vs 24 days, p = 0.024) and had fewer PN days (17 vs 23.5 days, p = 0.044) with no difference in adverse outcomes. Provision of > 20 mL/kg/day of enteral feeds during APAP treatment of PDA decreased time to full feeds and PN days compared to trophic feedings (≤ 20 mL/kg/day) with no difference in adverse GI outcomes. Continuing enteral feeding during APAP PDA treatment appears safe while improving achievement of nutritional milestones.

Genetic Foundation of Prostaglandin Metabolism Influences Patent Ductus Arteriosus Closure in Extremely Low Birth Weight Infants.

Prostaglandins (PGs) play a major role in maintaining patency of the ductal arteriosus (DA). Pulmonary 15-hydroxyprostaglandin dehydrogenase (PGDH), which is ecoded by the hydroxyprostaglandin dehydrogenase (HPGD) gene, is the primary enzyme responsible for PG breakdown. Animal studies have shown HPGD-knockout mice have significantly higher prostaglandin E2 levels and no ductal remodeling. Functional variants of the HPGD gene that alter PG breakdown have not been studied in preterm infants with patent ductus arteriosus (PDA). This was an observational cohort study including extreme low birth weight (ELBW) infants classified as having spontaneous, medical, or procedural (transcatheter or surgical ligation) closure of their DA. Urine prostaglandin E metabolite (PGEM) levels were measured in ELBW infants following ibuprofen treatment using competitive ELISA. HPGD genetic variants rs8752, rs2612656, and rs9312555 were analyzed. Kruskal-Wallis, Fisher's exact, chi square, logistic regression, and Wilcoxon signed-rank tests were used; p < 0.05 was considered significant. Infants in the procedural closure group had a younger gestational age (GA). The incidence of spontaneous closure or medical closure was higher compared to procedural closure in the presence of any minor allele of rs8752 (67 and 27%, respectively; p = 0.01), when adjusted for GA and gender. Haplotype analysis of three variants of HPGD revealed differences when comparing the spontaneous and medical closure group to the procedural group (p < 0.05). Urinary PGEM levels dropped significantly in those ELBW infants who responded to ibuprofen (p = 0.003) in contrast to those who did not respond (p = 0.5). There was a different genotype distribution for the rs8752 genetic variant of the HPGD gene-as it relates to the mode of treatment for ELBW infants with PDA. We speculate that medical management in the presence of this variant facilitated additional PG breakdown, significantly abrogating the need for procedural closure. Additionally, differences in genotype and haplotype distributions implicate a specific HPGD genetic foundation for DA closure in ELBW infants. · PGs and their metabolism play a major role in PDA patency or closure.. · Genetic variants of the HPGD gene influence mode of treatment of PDA in ELBW infants.. · ELBW infants with PDA that responded to medical closure had significantly decreased urine PGEM levels..

Timing of Red Blood Cell Transfusions and Occurrence of Necrotizing Enterocolitis

Observational studies often report that anemia and red blood cell (RBC) transfusions are associated with a higher risk of necrotizing enterocolitis (NEC) among extremely low-birthweight (ELBW) infants. To evaluate whether there is a temporal association between 72-hour hazard periods of exposure to RBC transfusions and NEC among ELBW infants randomized to either higher or lower hemoglobin transfusion thresholds. This post hoc secondary analysis of 1690 ELBW infants who survived to postnatal day 10 enrolled in the Transfusion of Prematures (TOP) randomized multicenter trial between December 1, 2012, and April 12, 2017, was performed between June 2021 and July 2023. First, the distribution of RBC transfusions and the occurrence of NEC up to postnatal day 60 were examined. Second, 72-hour posttransfusion periods were categorized as hazard periods and the pretransfusion periods of variable duration as control periods. Then, the risk of NEC in posttransfusion hazard periods was compared with that in pretransfusion control periods, stratifying the risk based on randomization group (higher or lower hemoglobin transfusion threshold group). The primary outcome was incidence of NEC stage 2 or 3. Secondary outcomes included the incidence rates of NEC within five 10-day intervals, taking into account the number of days at risk. Of 1824 ELBW infants randomized during the TOP trial, 1690 were included in the present analysis (mean [SD] gestational age, 26.0 [1.5] weeks; 899 infants [53.2%] were female). After categorizing 4947 hazard periods and 5813 control periods, we identified 133 NEC cases. Fifty-nine of these cases (44.4%) occurred during hazard periods. Baseline and clinical characteristics of infants with NEC during hazard periods did not differ from those of infants with NEC during control periods. The risk of NEC was 11.9 per 1000 posttransfusion hazard periods and 12.7 per 1000 control periods (adjusted risk ratio, 0.95; 95% CI, 0.68-1.32; P = .74). This risk did not differ significantly between randomization groups, but the incidence rate of NEC per 1000 days peaked between postnatal days 20 and 29 in the lower hemoglobin transfusion threshold group. The findings of this post hoc analysis suggest that, among ELBW infants with the hemoglobin ranges occurring in the TOP trial, exposure to RBC transfusions was not temporally associated with a higher risk of NEC during 72-hour posttransfusion hazard periods. Given that the incidence rate of NEC peaked between postnatal days 20 and 29 among infants with lower hemoglobin values, a more in-depth examination of this at-risk period using larger data sets is warranted. ClinicalTrials.gov Identifier: NCT01702805.

Early postnatal high-dose fat-soluble enteral vitamin A supplementation for moderate or severe bronchopulmonary dysplasia or death in extremely low birthweight infants (NeoVitaA): a multicentre, randomised, parallel-group, double-blind, placebo-controlled, investigator-initiated phase 3 trial

Vitamin A plays a key role in lung development, but there is no consensus regarding the optimal vitamin A dose and administration route in extremely low birthweight (ELBW) infants. We aimed to assess whether early postnatal additional high-dose fat-soluble enteral vitamin A supplementation versus placebo would lower the rate of moderate or severe bronchopulmonary dysplasia or death in ELBW infants receiving recommended basic enteral vitamin A supplementation. This prospective, multicentre, randomised, parallel-group, double-blind, placebo-controlled, investigator-initiated phase 3 trial conducted at 29 neonatal intensive care units in Austria and Germany assessed early high-dose enteral vitamin A supplementation (5000 international units [IU]/kg per day) or placebo (peanut oil) for 28 days in ELBW infants. Eligible infants had a birthweight of more than 400 g and less than 1000 g; gestational age at birth of 32+0 weeks postmenstrual age or younger; and the need for mechanical ventilation, non-invasive respiratory support, or supplemental oxygen within the first 72 h of postnatal age after admission to the neonatal intensive care unit. Participants were randomly assigned by block randomisation with variable block sizes (two and four). All participants received basic vitamin A supplementation (1000 IU/kg per day). The composite primary endpoint was moderate or severe bronchopulmonary dysplasia or death at 36 weeks postmenstrual age, analysed in the intention-to-treat population. This trial was registered with EudraCT, 2013-001998-24. Between March 2, 2015, and Feb 27, 2022, 3066 infants were screened for eligibility at the participating centres. 915 infants were included and randomly assigned to the high-dose vitamin A group (n=449) or the control group (n=466). Mean gestational age was 26·5 weeks (SD 2·0) and mean birthweight was 765 g (162). Moderate or severe bronchopulmonary dysplasia or death occurred in 171 (38%) of 449 infants in the high-dose vitamin A group versus 178 (38%) of 466 infants in the control group (adjusted odds ratio 0·99, 95% CI 0·73-1·55). The number of participants with at least one adverse event was similar between groups (256 [57%] of 449 in the high-dose vitamin A group and 281 [60%] of 466 in the control group). Serum retinol concentrations at baseline, at the end of intervention, and at 36 weeks postmenstrual age were similar in the two groups. Early postnatal high-dose fat-soluble enteral vitamin A supplementation in ELBW infants was safe, but did not change the rate of moderate or severe bronchopulmonary dysplasia or death and did not substantially increase serum retinol concentrations. Deutsche Forschungsgemeinschaft and European Clinical Research Infrastructures Network (ECRIN).

Long-term outcomes of very low birth weight infants with intraventricular hemorrhage: a nationwide population study from 2011 to 2019.

Advancements in neonatal care have increased preterm infant survival but paradoxically raised intraventricular hemorrhage (IVH) rates. This study explores IVH prevalence and long-term outcomes of very low birth weight (VLBW) infants in Korea over a decade. Using Korean National Health Insurance data (NHIS,2010-2019), we identified3372 VLBW infants with IVH among 4,129,808 live births.Health-related claims data, encompassing diagnostic codes, diagnostic test costs, and administered procedures were sourced from the NHIS database.The results of the developmental assessments are categorized into four groups based on standard deviation (SD) scores.Neonatal characteristics and complications were compared amongthe groups. Logistic regression models were employed to identify significant changes in the incidence of complications and to calculate odds ratios with corresponding 95% confidence intervals for each risk factor associated with mortality and morbidity in IVH.Long-term growth and developmentwere compared between the two groups(years2010-2013 and 2014-2017). IVH prevalence was 12% in VLBW and 16% in extremely low birth weight (ELBW) infants. Over the past decade, IVH rates increased significantly in ELBW infants (P = 0.0113), while mortality decreased (P = 0.0225). Major improvements in certain neurodevelopmental outcomes and reductions in early morbidities have been observed among VLBW infants with IVH. Ten percent of the population received surgical treatments such as external ventricular drainage (EVD) or a ventriculoperitoneal (VP) shunt, with the choice of treatment methods remaining consistent over time. The IVH with surgical intervention group exhibited higher incidences of delayed development, cerebral palsy, seizure disorder, and growth failure (height, weight, and head circumference) up to 72months of age (P < 0.0001). Surgical treatments were also significantly associated with abnormal developmental screening test results. The neurodevelopmental outcomes of infants with IVH, especially those subjected tosurgical treatments, continue to be a matter of concern. It is imperative to prioritize specialized care for patients receiving surgical treatments and closely monitor their growth and development after discharge to improve developmental prognosis. Supplementary file2 (MP4 77987 kb).