Eligible Babies Research Articles

Timing of Stoma Closure in Neonates: the ToSCiN mixed-methods study.

Neonates undergoing emergency abdominal surgery frequently require a stoma; closing this stoma with a second operation is an essential part of recovery. Timing of closure varies. Optimal timing is unclear and would be best resolved through a randomised controlled trial; such a trial is likely to be challenging. To determine if it is feasible to conduct a clinical trial comparing 'early' versus 'late' stoma closure in neonates. Mixed methods comprising three parallel workstreams incorporating: a clinician survey, prospective observational cohort study, parent interviews, focus groups, database analyses and consensus meeting. Specialist neonatal surgical centres across the United Kingdom. Neonatologists, neonatal surgeons, neonatal dietitians and neonatal nurses who care for neonates with stomas. Neonates with recent stoma, their parents and the clinicians looking after them. Three existing, overlapping clinical databases. One hundred and sixty-six professionals from all 27 neonatal surgical centres completed the survey: 6 weeks was the most common target time for stoma closure across clinical scenarios, although there was wide variation. Timing of closure was influenced by nutrition, growth and stoma complications. The prospective cohort study enrolled 56 infants from 8 centres. Infants were mostly preterm with necrotising enterocolitis or intestinal perforation. Clinicians identified extreme preterm gestation and clinical conditions as reasons for not randomising babies into a hypothetical trial comparing early and late stoma closure. Parents and healthcare professionals identified that comparator arms needed more clinical flexibility in relation to timing of stoma closure. Analysis of existing databases revealed wide variation in current timing of stoma closure in neonates and identified approximately 300 eligible infants for a trial per annum in the United Kingdom. A trial of 'early' compared to 'late' stoma closure in neonates is feasible and is important to families and health professionals. The population of eligible babies in the United Kingdom is sufficient for such a trial. Challenges centre around lack of equipoise in certain scenarios, specifically: extremely preterm infants; infants waiting too long for stoma closure in the 'late' comparator; and logistical issues in closing a stoma at a trial-allocated time. These challenges are addressable by incorporating flexibility based on gestation at birth, communicating that both trial arms are standard practice and valid treatment options, and providing resources, for example, for operating lists. We recommend the following population, intervention, comparator and outcome as a starting point to inform future trial design. Population: neonates with stomas (excluding those with a fixed treatment pathway). Intervention: stoma closure at 6 weeks and after 32 weeks post conceptual age. Comparator: expectant management with stoma closure undertaken when the clinical team determines is best for the infant. Primary outcomes: weight gain/growth or length of hospital stay. This study is registered as IRAS Project ID 278331, REC Reference 20/LO/1227. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR128617) and is published in full in Health Technology Assessment; Vol. 28, No. 71. See the NIHR Funding and Awards website for further award information.

Frequency and Risk Factors Associated with Prematurity: A Cohort Study in a Neonatal Intensive Care Unit.

Background/Objectives: Prematurity rates remain high and represent a challenge for the public health systems of any country, with a high impact on neonatal mortality. This study aimed to evaluate the frequency and environmental and maternal-fetal risk factors for premature birth in a cohort of parturient women, with their newborns monitored in a neonatal intensive care unit at a private reference hospital. Methods: A cohort was carried out between 2013 and 2018 among parturient women living in a capital city in the Northeast of Brazil whose newborns were admitted to the neonatal intensive care unit. This study was approved by the Research Ethics Committee of the University of Fortaleza. The information collected comprised data from both medical records and hydrosanitary data from maternal homes. Results: The prevalence of prematurity among live births (n = 9778) between 2013 and 2018 at this hospital was 23%. The frequency of prematurity among those eligible (n = 480) was 76.9%, and the frequency of eligible premature babies (n = 369) in relation to the total number of births in this period was 3.8%. In the multivariate analysis, the significant risk factors for prematurity were primigravida (RR = 1.104, 95%CI: 1.004-1.213) and hypertensive syndromes during pregnancy (RR = 1.262, 95%CI: 1.161-1.371), and the significant protective factor was the highest number of prenatal consultations (RR = 0.924, 95%CI: 0.901-0.947). Conclusions: This study contributes to providing greater visibility to prenatal care and the understanding of complications during pregnancy and childbirth care. These results indicate the need to implement public policies that promote improvements in the population's living conditions and care for pregnant women to reduce premature births and, consequently, neonatal and infant mortality.

Comparison of porcine versus bovine surfactant in preterm respiratory distress syndrome: Evidence from real-world data. A multicentre collaboration from Karnataka.

Porcine surfactant (200 mg/kg initial dose) seems to be superior to bovine surfactants (100 mg/kg) in respiratory distress syndrome (RDS). There is limited data on the choice of surfactant from the developing world. Logically, using higher doses of porcine surfactant comes with an additional cost burden. We decided to evaluate the clinical effects of different types of surfactants. A retrospective analysis was conducted from August 2019 to December 2022 in six tertiary centers. Neonates 24-34 weeks of gestation with RDS requiring either porcine (200 mg/kg) or bovine surfactant (100 mg/kg) were enrolled. The proportion of BPD, redosing, and other morbidities in either group were analyzed. The outcomes in preterm ≥28and <28 weeks subgroups were analyzed. Of 1149 eligible babies, 302 (26%) received surfactant after stabilization with CPAP. One hundred fifty-eight received porcine, and 144 received bovine surfactant. There was a higher BPD in porcine compared to the bovine group on univariate analysis [24 (15%) vs. 6 (4%); OR: 4; 95% CI: 1.6-10; p = 0.002]. On logistic regression, the gestational age and PDA requiring treatment were independent predictors of BPD, and the type of surfactant and centres did not influence BPD. Redosing [27 (17%) vs. 18 (12%), OR: 1.4; 95% CI: 0.7-2.7; p = 0.2] was not different between both surfactant types. Other morbidities like mortality, air leaks, invasive ventilation, and CPAP duration were also not different between the groups. We could not find a difference in the outcomes of BPD and redosing using porcine surfactant at 200 mg/kg compared to bovine surfactant. Considering the cost burden in the developing world, efficacy needs to be evaluated in randomized clinical trials.

Knowledge, Attitude, and Practices Toward Kangaroo Mother Care Among Mothers in a Tertiary Neonatal Care Unit

Aim: To study the knowledge, attitude, and practices of Kangaroo Mother Care (KMC) among eligible postnatal mothers in the postnatal ward (PNW) and neonatal intensive care unit (NICU) of a tertiary neonatal unit in Eastern India. Methods: A cross-sectional survey was conducted among 100 mothers of low-birth-weight babies in our PNW and NICU. As part of the unit protocol, all mothers of eligible babies were counseled about KMC at first contact verbally as well as by using an informative video on KMC. Data was collected using a structured questionnaire after the routine counseling of the mothers on their first visit after delivery. The analysis of the data was done using appropriate statistics. Results: More than three-fourths (83.2%) of mothers had good knowledge of KMC. A good attitude toward using KMC was found in 91.6% of the mothers. Almost all the mothers (98%) knew the correct KMC position, and 12% of mothers had a previous preterm baby and had given KMC. Many mothers felt the small size of the baby, pain after cesarean section, and central or peripheral intravenous lines in the baby were barriers to KMC. Conclusion: The knowledge regarding KMC among mothers whose babies were admitted into the PNW/NICU was good. Though the attitude toward KMC was good, mothers felt there were multiple barriers to initiating KMC.

Kangaroo Mother Care in a Tertiary Hospital in Northeast India: A 36-month Quality Improvement Initiative

Background: Kangaroo mother care (KMC) is a special method of care for low birth weight and preterm babies by providing early and prolonged skin-to-skin contact with the mother and exclusive breastfeeding. It is a simple and cost-effective ways to take care of low-birth-weight babies. Objectives: To give KMC as a routine practice and to provide extended KMC to all eligible babies. Methodology: We conducted a Quality improvement (QI) study in our out-born neonatal unit from July 2020, and reviewed every six month till June 2023. A QI team comprising of staff nurses and doctors was formed. The root cause analysis for doing KMC was evaluated using a fishbone diagram, and the issues were addressed using prioritization matrix. Multiple Plan-Do-Study-Act (PDSA) cycles were conducted. Results were analysed using descriptive statistics. Results: A total of 105 babies were enrolled during this period. The mean gestation age was 32 ± 3.28 weeks. The average weight was 1577 ± 417 grams. Our baseline was two hours and 30 minutes per baby per day. We did a total of three PDSA cycles, and as of June 2023, we were able to give an average of 5.3 hours per baby per day. Conclusion: Our QI measures ensured that KMC was provided to all eligible low-birth-weight babies with proper documentation. Sensitizing and capacity-building our nursing staffs on KMC empowered them and helped to achieve and sustain our aim.

Initiation Rate of First-hour Breastfeeding in Healthy Term and Near Term Babies: Outcome Assessment After Quality Improvement Methods in Secondary Care District Hospital

Objective To improve the rate of first-hour breastfeeding in term and near-term healthy neonates by a quality improvement (QI) study at Secondary Care District Hospital. Design QI study. Setting Labor room-operation theatre of a secondary care district hospital. Participants Stable newborns ≥35 weeks of gestation born by normal vaginal delivery and by cesarean section under spinal anesthesia. Procedure A team of nurses, pediatricians, obstetricians, and anesthetists analyzed possible reasons for delayed initiation of breastfeeding by flow chart and Fishbone analysis. Various change ideas were tested through sequential Plan-Do-Study-Act cycles. Outcome measure Proportion of eligible babies breastfed within 1 hour of delivery. Results The rate of first-hour initiation of breastfeeding increased from 69% to 88% in normal vaginal deliveries and from 17% to 61% in the cesarian section over the study period, which were sustained up to 80% in normal vaginal deliveries (NVD) and 55% in lower segment cesarean section. Conclusions A QI approach was able to accomplish sustained improvement in first-hour breastfeeding rates in normal and cesarean deliveries.

Kaiser Permanente early-onset sepsis calculator as a safe tool for reducing antibiotic use among chorioamnionitis-exposed term neonates: Qatar experience

Being an important cause of early-onset neonatal sepsis, clinical chorioamnionitis in the mother results in frequent laboratory workup and antibiotic use for the neonate. Neonatal intensive care units (NICUs) in...

Midwife or doctor leader to implement a national guideline in babies on postnatal wards (DesIGN): A cluster-randomised, controlled, trial.

The aim of this trial was to determine if midwives or doctor leaders are more effective at implementing a clinical practice guideline for oral dextrose gel to treat neonatal hypoglycaemia. This was a cluster-randomised, controlled, trial. New Zealand maternity hospitals were randomised to guideline implementation by a midwife or doctor implementation leader. The primary outcome was the change in the proportion of hypoglycaemic babies (blood glucose concentration <2.6 mmol/L in the first 48 hours after birth), treated with dextrose gel from before, to three months after, implementation. Twenty-one maternity hospitals that cared for babies at risk of hypoglycaemia consented to participate, of which 15 treated babies with hypoglycaemia at both time points (7 randomised to midwifery led, 8 randomised to doctor led implementation). The primary outcome included 463 hypoglycaemic babies (292 midwifery led, 171 doctor led implementation). There was no difference in the primary outcome between hospitals randomised to midwifery or doctor led implementation (proportion treated with gel, mean(SD); midwifery led: before 71 (38)%, 3 months after 87 (12)%; doctor led: before 63 (43)%, 3 months after 86 (16)%; adjusted mean change in proportion (95%CI); 19.3% (-4.5-43.1), p = 0.11). There was an increase in the proportion of eligible babies treated with oral dextrose gel from before to 3 months after implementation of the guideline (122/153 (80%) v 144/163 (88%), OR (95%CI); 3.42 (1.67-6.98), p<0.001). Implementation of a clinical practice guideline improved uptake of oral dextrose gel. There was no evidence of a difference between midwife and doctor implementation leaders for implementing this guideline for treatment of hypoglycaemic babies. The trial was prospectively registered on the ISRCTN registry on the 20/05/2015 (ISRCTN61154098).

Development and evaluation of a kangaroo mother care implementation model in South Ethiopia.

To develop a model for increasing the coverage of kangaroo mother care (KMC), which involved ≥8 h of skin-to-skin contact per day and exclusive breastfeeding, for small babies with birth weight < 2000 g in South Ethiopia. A mixed methods study was conducted between June 2017 and January 2019 at four hospitals and their catchment areas. Iterative cycles of implementation, program learning and evaluation were used to optimise KMC implementation models. The study explored the community-facility continuum of care and assessed the proportion of neonates with a birth weight less than 2000 g receiving effective KMC. Three KMC implementation models were tested with Model 2 being the final version. This model included enhanced identification of home births, improved referral linkages, immediate skin-to-skin care initiation in facilities and early contact after discharge. These improvements resulted in 86% coverage of effective facility-based KMC initiation for eligible babies. The coverage was 81.5% at discharge and 57.5% 7 days after discharge. The mean age of babies at KMC initiation was 8.2 days (SD = 5.7). The study found that the KMC implementation model was feasible and can lead to substantial population-level KMC coverage for small babies.

Safety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomised, phase 2 non-inferiority double-blind controlled trial

Tuberculosis is a major public health problem worldwide. Immunisation with Mycobacterium bovis BCG vaccine is partially effective in infants, reducing the incidence of miliary and tuberculosis meningitis, but is less effective against pulmonary tuberculosis. We aimed to compare safety and immunogenicity of VPM1002-a recombinant BCG vaccine developed to address this gap-with BCG in HIV exposed and HIV unexposed newborn babies. This double-blind, randomised, active controlled phase 2 study was conducted at four health centres in South Africa. Eligible neonates were aged 12 days or younger with a birthweight of 2·5-4·2 kg, and could be HIV exposed (seropositive mothers) or unexposed (seronegative mothers). Newborn babies were excluded if they had acute or chronic illness, fever, hypothermia, sepsis, cancer, or congenital malformation, or if they received blood products or immunosuppressive therapy. Participants were excluded if their mothers (aged ≥18 years) had active tuberculosis disease, diabetes, a history of immunodeficiency except for HIV, hepatitis B or syphilis seropositivity, received blood products in the preceding 6 months, any acute infectious disease, or any suspected substance abuse. Participants were randomly assigned to VPM1002 or BCG vaccination in a 3:1 ratio, stratified by HIV status using the random number generator function in SAS, using a block size of eight paticipants. The primary outcome was non-inferiority (margin 15%) of VPM1002 to BCG vaccine in terms of incidence of grade 3-4 adverse drug reactions or ipsilateral or generalised lymphadenopathy of 10 mm or greater in diameter by 12 months. The primary outcome was assessed in all vaccinated participants (safety population) at regular follow-up visits until 12 months after vaccination. Secondary immunogenicity outcomes were interferon-γ levels and percentages of multifunctional CD4⁺ and CD8⁺ T cells among all lymphocytes across the 12 month study period. The study was registered with ClinicalTrials.gov, NCT02391415. Between June 4, 2015 and Oct 16, 2017, 416 eligible newborn babies were randomly assigned and received study vaccine. Seven (2%) of 312 participants in the VPM1002 group had a grade 3-4 vaccine-related adverse reaction or lymphadenopathy of 10 mm or greater in diameter compared with 34 (33%) of 104 participants in the BCG group (risk difference -30·45% [95% CI -39·61% to -21·28%]; p_{non-inferiority}&lt;0·0001); VPM1002 was thus non-inferior to BCG for the primary outcome. Incidence of severe injection site reactions was lower with VPM1002 than BCG: scarring occurred in 65 (21%) participants in the VPM1002 group versus 77 (74%) participants in the BCG group (p&lt;0·0001); ulceration occurred in one (&lt;1%) versus 15 (14%; p&lt;0·0001); and abscess formation occurred in five (2%) versus 23 (22%; p&lt;0·0001). Restimulated IFNγ concentrations were lower in the VPM1002 group than the BCG group at week 6, week 12, month 6, and month 12. The percentage of multifunctional CD4⁺ T cells was higher in the VPM1002 group than the BCG group at day 14 but lower at week 6, week 12, month 6, and month 12. The percentage of multifunctional CD8⁺ T cells was lower in the VPM1002 group than the BCG group at week 6, week 12, and month 6, but did not differ at other timepoints. VPM1002 was less reactogenic than BCG and was not associated with any serious safety concern. Both vaccines were immunogenic, although responses were higher with the BCG vaccine. VPM1002 is currently being studied for efficacy and safety in a multicentric phase 3 clinical trial in babies in sub-Saharan Africa. Serum Institute of India.

Government-led initiative increased the effective use of Kangaroo Mother Care in a region of North India.

To learn how to achieve high-quality, effective coverage of Kangaroo Mother Care (KMC), defined as 8hours or more of skin-to-skin contact per day and exclusive breastfeeding in district Sonipat in North India, and to develop and evaluate an implementation model. We conducted implementation research using a mixed-methods approach, including formative research, followed by repeated, rapid cycles of implementation, evaluation and refinement until a model with the potential for high and effective coverage was reached. Evaluation of this model was conducted over a 12-month period. Formative research findings informed the final implementation model. Programme learning was critical to achieve high coverage. The model included improving the identification of small babies, creating KMC wards, modification in hospitalisation criteria, private sector engagement and in-built programme learning to refine implementation progress. KMC was initiated in 87% of eligible babies. At discharge, 85% received skin-to-skin contact care, 60% effective KMC and 80% were exclusively breastfed. At home, 7-day post discharge, 81% received skin-to-skin care and 79% were exclusively breastfed in the previous 24hours. Achieving high KMC coverage is feasible in the study setting using a model responsive to the local context and led by the Government.

1045-P: Relative Cord Hyperleptinaemia Is Associated with Higher Cord C Peptide and Lower Birthweight in Male but Not Female Neonates Born to Overweight/Obese Women

Aim: Umbilical cord leptin is higher than expected in some babies (relative cord hyperleptinaemia) . We test the hypothesis that a higher cord leptin:fat mass ratio, putatively reflecting “leptin resistance” might be associated with adverse pregnancy outcomes. Methods: Secondary analyses from Vitamin D And Lifestyle Intervention for gestational diabetes prevention (DALI) trial a pan European study among women with a BMI ≥29 kg/m2 between 2012-14. Cord sampling and skin caliper measurements followed standardized methods. Serum cord leptin (µg/l) to fat mass ratio (kg) was classified into low, middle, and high tertiles across (where stated) and within sexes. Large/small for gestational age (SGA) used GROW. Pregnancy outcomes were compared between low and high tertiles adjusted for potential confounders using binomial logistic regression. Results: Among the 349 eligible babies (mean gestational age 39.7 ± 1.4 weeks, female 49%) the median (interquartile range) leptin-fat mass ratio (both sexes combined) was 20.2 (11.4-30.8) , top tertile (TT) was &amp;gt;25.3 and low tertile (LT) was &amp;lt;14.9 . Compared with babies in the LT group, those in the TT group had higher cord erythropoietin (30.2 (16.7-59.2) vs. 20.3 (12.4-35.6) µg/l p = 0.002, respectively, both sexes) with higher cord serum C peptide (0.7 (0.5­-1.0) vs. 0.5 (0.3-0.8) µg/l p = 0.005) , lower birthweight (3435 ± 5vs. 37± 412 gm, p = 0.002) in boys but not in girls. Cord glucose was similar. Among males, those in the TT had higher risk of SGA (25.0% vs. 8.5%; OR 3.61 (95%CI 1.21-10.76)) but lower risk of cesarean section (0.39 (0.17-0.88)) . Among females, mothers in the TT had higher rate of pregnancy induced hypertension (3.93 (1.21-12.71)) . Conclusions: Relative cord hyperleptinaemia is associated with reduced fetal growth (boys only) , and possible relative fetal hypoxia (both sexes) . Further studies are required to evaluate the implications of these findings on future metabolism. Disclosure J.Immanuel: None. D.M.Jensen: None. E.R.Mathiesen: Consultant; Novo Nordisk A/S, Speaker's Bureau; Novo Nordisk A/S. D.J.Hill: None. P.Damm: Advisory Panel; Novo Nordisk A/S. F.J.Snoek: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Roche Diabetes Care, Research Support; Novo Nordisk A/S, Sanofi, Speaker's Bureau; Insulet Corporation. J.Adelantado: None. E.Wender-ozegowska: None. D.Simmons: Other Relationship; Elsevier, Research Support; Abbott, Hitachi, Ltd., Novo Nordisk, Speaker's Bureau; Sanofi. G.Desoye: None. M.Vanpoppel: None. A.Kautzky-willer: None. R.Corcoy: None. A.Bertolotto: Research Support; AstraZeneca, Novo Nordisk, Speaker's Bureau; Abbott Diagnostics, Lilly Diabetes. F.P.Dunne: None. J.Harreiter: None. L.Andersen: None. Funding EU FP7 (242187)

Uterine activity in labour and the risk of neonatal encephalopathy: a case control study

ObjectiveTo determine the relationship between intrapartum contraction frequency, rest interval duration, and cervical dilation speed and the risk of neonatal hypoxic-ischemic encephalopathy (HIE). Study DesignThis was a retrospective case-control study conducted in a maternity hospital in Dublin, Ireland. Babies born without major congenital anomalies between September 2006 and November 2017 at ≥ 35 + 0 weeks’ gestational age were eligible. Cases were diagnosed with moderate-severe HIE. The controls were the first eligible baby born before and after each case with normal Apgar scores and not admitted to the neonatal unit.Intrapartum uterine activity was assessed by automated analysis of external tocography recordings. Cervical dilation was assessed by linear interpolation between vaginal examination measurements. The speed of cervical dilation was expressed as the times from 4 to 6 cm, >6 cm to the start of pushing, and from pushing to delivery. ResultsIntrapartum tocographs results were available in 49 of 88 cases and 121 of 176 controls. The median contraction rate in cases was 7.7 (Interquartile range [IQR]: 6.6–9.0) compared to 7.0 in controls (IQR: 6.2–7.9) (p = 0.021). The median rest interval duration was 56 s (IQR: 38–76) in cases and 62 s (IQR: 50–79) in controls (p = 0.058). Cases took longer to progress from > 6 cm to the start of pushing (cases: 02:58 [01:14–04:49], controls: 01:48 [00:51–03:34], p = 0.020) and from pushing to delivery (cases: 00:34 [00:24–01:10], controls: 00:27 [00:13–00:56], p = 0.036). ConclusionsHigher contraction frequencies and slower progress towards the end of labour are both independently associated with the risk of moderate-severe HIE. Inter-contraction rest interval duration as measured by external tocography does not provide additional accuracy.

Fetal heart rate patterns in labor and the risk of neonatal encephalopathy: A case control study

ObjectiveTo describe the accuracy of intrapartum fetal heart rate abnormalities as defined by National Institute of Health and Care Excellence guidelines to predict moderate-severe neonatal encephalopathy of apparent hypoxic-ischemic etiology. Study designA case-control study of HIE risk factors was conducted. Eligible babies were born in a single maternity hospital in Dublin, Ireland between September 2006, and November 2017 at ≥35 + 0 weeks’ gestational age. Cases were eligible babies with moderate-severe neonatal encephalopathy of definite or apparent hypoxic-ischemic etiology. Controls were eligible babies born before and after each case with normal Apgar scores.The included subjects who had intrapartum fetal heart rate recordings were identified. Pattern features (baseline rate, variability, accelerations, decelerations [early, late, variable, prolonged], bradycardia, sinusoidal pattern) were manually identified blind to all clinical details by one of the authors. Each 15-minute segment was then algorithmically categorized (uninterpretable, normal, suspicious, pathological). ResultsOf 88 cases and 176 controls, 71 cases (81%) and 146 controls (83%) were admitted to the delivery suite in labor. From that group, intrapartum FHR traces longer than 15 min were available for 52 (73%) cases and 118 (83%) controls.The FHR pattern feature with the largest area under the receiver operating characteristic curve was the maximum number of consecutive segments in which the baseline was >160 bpm (0.71 [95% confidence interval: 0.62–0.80]). The category variable with the highest area under the curve was the number of suspicious segments (0.76 [95% confidence interval: 0.67–0.84]).A tri-variate logistic regression model incorporating the total number of segments, the number of “suspicious” segments classed, and the number of “pathological” segments achieved an area under the curve of 0.78 (95% confidence interval: 0.70–0.86). With 95% specificity, this model correctly identified 17 cases (33%) at a median time before delivery of 2 h and 18 min (interquartile range: 01:19–04:40). ConclusionsThe power of fetal heart rate analysis to predict neonatal encephalopathy is hampered by poor specificity given the rarity of the outcome. When analyzing a suspicious trace, it is beneficial to consider the overall duration of the suspicious pattern.

Nutritional Management of Moderate- and Late-Preterm Infants Commenced on Intravenous Fluids Pending Mother's Own Milk: Cohort Analysis From the DIAMOND Trial.

BackgroundExclusive breastmilk is the desired enteral nutrition for babies born moderate- and late-preterm between 32+0 and 36+6 weeks' gestation; however, this goal is often difficult to achieve.MethodsA prospective cohort of babies 32+0 −35+6 weeks' gestation enrolled in the DIAMOND trial were randomized to a condition specifying that babies should receive mother's own milk (MOM) as the only enteral feed. Factors associated with the successful transition to MOM, defined as MOM being the sole enteral feeding at the time of the first cessation of intravenous (IV) fluids, were investigated by logistic regression. Time to commencement of a milk other than MOM was analyzed by Kaplan–Meier survival curves.ResultsA total of 151 eligible babies (60% boys) were included, 93 (63%) of whom successfully transitioned from IV fluids onto MOM only. Alternative sources of milk, mostly formula, were used to transition from IV fluids onto enteral feeds more often in multiples and Māori, and was commenced earlier in Māori than other ethnicities (p = 0.007) and in late-preterm compared with moderate-preterm babies (p=0.01). Receiving exclusively breastmilk at discharge was more likely for babies who successfully transitioned from IV fluids onto MOM only [OR (95% confidence intervals) 4.9 (2.3–10.6)] and who received only MOM in the first week after birth [4.8 (2.2–10.4)], both p < 0.0001. Receiving breastmilk exclusively at discharge was less likely for Māori than Caucasian babies [0.2 (0.1–0.6), p < 0.0006]. There was no difference in the use of alternative sources of milk in babies who received parenteral nutrition or dextrose or between small-for-gestational-age and appropriate-for-gestational-age babies.ConclusionsDespite an intention to provide only MOM, significant numbers of moderate- and late-preterm babies received formula to transition from IV fluids, and this differed by ethnicity. The drivers underlying these decisions require further investigation. These data highlight an urgent need for quality initiatives to support and encourage mothers of moderate- and late-preterm babies in their lactation.

Improving Recruitment for a Newborn Screening Pilot Study with Adaptations in Response to the COVID-19 Pandemic.

Seven months after the launch of a pilot study to screen newborns for Duchenne Muscular Dystrophy (DMD) in New York State, New York City became an epicenter of the coronavirus disease 2019 (COVID-19) pandemic. All in-person research activities were suspended at the study enrollment institutions of Northwell Health and NewYork-Presbyterian Hospitals, and study recruitment was transitioned to 100% remote. Pre-pandemic, all recruitment was in-person with research staff visiting the postpartum patients 1–2 days after delivery to obtain consent. With the onset of pandemic, the multilingual research staff shifted to calling new mothers while they were in the hospital or shortly after discharge, and consent was collected via emailed e-consent links. With return of study staff to the hospitals, a hybrid approach was implemented with in-person recruitment for babies delivered during the weekdays and remote recruitment for babies delivered on weekends and holidays, a cohort not recruited pre-pandemic. There was a drop in the proportion of eligible babies enrolled with the transition to fully remote recruitment from 64% to 38%. In addition, the proportion of babies enrolled after being approached dropped from 91% to 55%. With hybrid recruitment, the proportion of eligible babies enrolled (70%) and approached babies enrolled (84%) returned to pre-pandemic levels. Our experience adapting our study during the COVID-19 pandemic led us to develop new recruitment strategies that we continue to utilize. The lessons learned from this pilot study can serve to help other research studies adapt novel and effective recruitment methods.

Maintaining Normothermia in Preterm Babies during Stabilisation with an Intact Umbilical Cord.

Background: We had experienced an increase in admission hypothermia rates during implementation of deferred cord clamping (DCC) in our unit. Our objective was to reduce the number of babies with a gestation below 32 weeks who are hypothermic on admission, whilst practising DCC and providing delivery room cuddles (DRC). Method: A 12 month quality improvement project set, in a large Neonatal Intensive Care Unit, from January 2020 to December 2020. Monthly rates of admission hypothermia (<36.5 °C) for all eligible babies, were tracked prospectively. Each hypothermic baby was reviewed as part of a series of Plan, Do, Study Act (PDSA) cycles, to understand potential reasons and to develop solutions. Implementation of these solutions included the dissemination of the learning through a variety of methods. The main outcome measure was the proportion of babies who were hypothermic (<36.5 °C) on admission compared to the previous 12 months. Results: 130 babies with a gestation below 32 weeks were admitted during the study period. 90 babies (69.2%) had DCC and 79 babies (60%) received DRC. Compared to the preceding 12 months, the rate of hypothermia decreased from 25/109 (22.3%) to 13/130 (10%) (p = 0.017). Only 1 baby (0.8%) was admitted with a temperature below 36 °C and 12 babies (9.2%) were admitted with a temperature between 36 °C and 36.4 °C. Continued monitoring during the 3 months after the end of the project showed that the improvements were sustained with 0 cases of hypothermia in 33 consecutive admissions. Conclusions: It is possible to achieve low rates of admission hypothermia in preterm babies whilst providing DCC and DRC. Using a quality improvement approach with PDSA cycles is an effective method of changing clinical practice to improve outcomes.

Implementation research on kangaroo mother care, Bangladesh.

ObjectiveTo describe the implementation, coverage and performance of the national kangaroo mother care programme in Bangladesh.MethodsKangaroo mother care services for clinically stable babies with birth weight under 2000 g were set up in government-run health-care facilities in rural and urban areas of Bangladesh. Each facility provided counselling on kangaroo mother care, ensured adequate nutrition, and followed up mothers and babies. We studied implementation of the programme from January 2016 to March 2020 using data from the national database. We tracked the number of eligible babies enrolled and their outcomes, mortality and post-discharge follow-up.FindingsThe numbers of kangaroo mother care facilities increased from 16 in 2016 to 108 in 2020. Over the 4-year period 64 426 babies weighing under 2000 g were born in these facilities, 6410 of whom received kangaroo mother care. The quarterly percentage of eligible babies receiving kangaroo mother care increased from 4.7% (37/792) during the first quarter to 21.7% (917/4226) during the last five quarters of the programme. Deaths of babies receiving kangaroo mother care showed a downward trend over the study period. The overall mortality was 1.2% (77/6410), with large quarterly fluctuations in mortality. Post-discharge follow-up was low and only 15–20% of babies received four follow-up visits.ConclusionImplementation of kangaroo mother care interventions is feasible in low-resource settings. Such care has the potential to reduce mortality among low-birth-weight and premature babies. Challenges include low coverage, expanding the programme to the community and strengthening the monitoring system.

Comparative evaluation of the clinical effects of high Air-Through soft diaper and standard diaper in Indian babies with diaper rash

The incidence of diaper dermatitis (rash) in India is reported to be in the range of four to thirty-five per cent in children up to 2 years of age. To evaluate the clinical effect of using High Air-Through Soft Diaper and babies’ favourite diaper (Standard diaper) on Indian babies’ skin. This was a single-blinded, randomized, controlled, cross-over study. Eligible babies were randomized in two treatment groups. Babies in Group A used High Air-Through Soft Diaper for the first two weeks and then used standard diaper for the next 2 weeks. Babies in Group B used a standard diaper for the first two weeks and then used a High Air-Through Soft Diaper for the next 2 weeks. The study was completed with 105 babies. Theevaluation of the skin using the scoring system and photographs for representative purposes. At baseline, the mean total diaper rash scores were comparable in both Group A and Group B viz. 3.04 ± 1.00 and 3.30 ± 1.04 respectively and the difference was not statistically significant (p = 0.195). After 2 weeks, the mean total diaper rash score increased significantly from the baseline in both Group A and Group B (5.05 ± 1.97; p = 0.001 and 6.16 ± 2.22, p = 0.001 respectively); the rise in the mean total diaper rash score was significantly more in Group B than that in Group A (p = 0.045). After 4 weeks, a significant increase in the mean total diaper rash score (1.31 ± 2.69; p =0.001) was observed from what it was at 2 weeks in the Group A and there was an insignificant decrease in the mean total diaper rash score (-0.52 ± 2.54; p =0.153) in Group B from what it was at 2 weeks; the change in the mean total diaper rash score was significantly more in Group A than that in Group B (P = 0.001). Both High Air-Through Soft Diaper and standard diaper in babies caused a significant increase in mean total diaper rash score. However, the extent and the degree of rash induced with the use of High Air-Through Soft Diaper was significantly less than that during the usage of the standard diaper. Thus, High Air-Through Soft Diaper due to technologies used in it appears to be superior to the standard diaper in reducing the mean total diaper rash score.

A Quality Improvement Initiative: Improving First-hour Breastfeeding Initiation Rate among Healthy Newborns.

Introduction:“No matter where a newborn takes his or her first breath, the desire to give that baby the best start in life is universal.” The best gift a mother can give her baby is the gift of health. The gift of health can be given to the baby through early and adequate breastfeeding. Globally, only 2 out of 5 newborns are put to the breast within the first hour of life. Therefore, initiating breastfeeding is an evidence-based intervention for improving neonatal survival.Methods:We aimed to improve the first-hour breastfeeding initiation rate from the existing 12%–80% over 3 months through a quality improvement (QI) process. The setting was antenatal, perinatal, and postnatal wards of the Maharishi Markandeshwar Institute of Medical Sciences And Research Hospital. The participants were postpartum mothers with stable newborns 35 weeks and older of gestation born by normal vaginal delivery.Procedure for QI:A team of nurses and obstetricians was formed; we analyzed possible reasons for delayed initiation of breastfeeding by process cycle matrix chart and Fishbone analysis. Various change ideas were tested through sequential Plan-Do-Study-Act cycles. The outcome measure is the proportion of eligible babies breastfed within 1 hour of delivery.Results:After 3 months, the first-hour initiation of breastfeeding increased from 12% to 80%, without additional resources.Conclusions:A QI approach achieved an improvement in first-hour breastfeeding rates after normal vaginal delivery.