Comparison between the for-profit human milk industry and nonprofit human milk banking: Time for regulation?

Human milk (HM) is a highly evolutionary selected, complex biofluid, which provides tailored nutrition, immune system support and developmental cues that are unique to each maternal-infant dyad. In the absence of maternal milk, the World Health Organisation recommends vulnerable infants should be fed with screened donor HM (DHM) from a HM bank (HMB) ideally embedded in local or regional lactation support services. However, demand for HM products has arisen from an increasing awareness of the developmental and health impacts of the early introduction of formula and a lack of prioritisation into government-funded and nonprofit milk banking and innovation. This survey of global nonprofit milk bank leaders aimed to outline the trends, commonalities and differences between nonprofit and for-profit HM banking, examine strategies regarding the marketing and placement of products to hospital and public customers and outline the key social, ethical and human rights concerns. The survey captured information from 59 milk bank leaders in 30 countries from every populated continent. In total, five companies are currently trading HM products with several early-stage private milk companies (PMCs). Products tended to be more expensive from PMC than HMB, milk providers were financially remunerated and lactation support for milk providers and recipients was not a core function of PMCs. Current regulatory frameworks for HM vary widely, with the majority of countries lacking any framework, and most others placing HM within food legislation, which does not include the support and care of milk donors and recipient prioritisation. Regulation as a Medical Product of Human Origin was only in place to prevent the sale of HM in four countries; export and import of HM was banned in two countries. This paper discusses the safety and ethical concerns raised by the commodification of HM and the opportunities policymakers have globally and country-level to limit the potential for exploitation and the undermining of breastfeeding.

Target product profiles for diagnosis of sepsis: Proposing a new approach for diagnostic innovation.

Background & objectives: Sepsis, including neonatal sepsis, remains a prevalent cause of morbidity and mortality in low- and middle-income countries such as India, representing 85 per cent of all sepsis-related deaths globally. Early diagnosis and timely initiation of treatment is challenging due to non-specific clinical manifestations and non-availability of rapid diagnostic tests. There is an urgent need for affordable diagnostics with fast turnaround time catering to the needs of end-users. Target product profiles (TPPs) have been found instrumental in developing 'fit-for-use' diagnostics, thus reducing the time taken to facilitate development and improving diagnosis. Hitherto, no such guidance or criteria has been defined for rapid diagnostics for sepsis/neonatal sepsis. We propose an innovative approach for developing the diagnostics for sepsis screening and diagnosis which can be utilized by diagnostic developers in the country. Methods: Thr@ee-round Delphi method, including two online surveys and one virtual consultation, was adopted to define criteria for minimum and optimum attributes of TPPs and build consensus on characteristics. Expert panel (n=23) included infectious disease physicians, public health specialists, clinical microbiologists, virologists, researchers/scientists and technology experts/innovators. Results: We present a three-component product profile for sepsis diagnosis, (i) screening with high sensitivity, (ii) detection of aetiological agent, and (iii) profiling of antimicrobial susceptibility/resistance, in adults and neonates with an option of testing different considerations. An agreement of >75 per cent was achieved for all TPP characteristics by Delphi. These TPPs are tailored to the Indian healthcare settings and can also be extrapolated to other resource-constraint and high-disease burden settings. Interpretation & conclusions: Diagnostics developed using these TPPs will facilitate utilization of invested resources leading to development of the products that have potential to ease the economic burden on patient and save lives.

Outcomes of Nonvigorous Neonates Born through Meconium-Stained Amniotic Fluid after a Practice Change to No Routine Endotracheal Suctioning from a Developing Country.

OBJECTIVE: The International Liaison Committee on Resuscitation (ILCOR) 2015 gave a weak recommendation based on low certainty of evidence against routine endotracheal (ET) suctioning in non-vigorous (NV) neonates born through meconium-stained amniotic fluid (MSAF) and suggested for immediate resuscitation without direct laryngoscopy. A need for ongoing surveillance post policy change has been stressed upon. This study compared the outcomes of NV MSAF neonates before and after implementation of the ILCOR 2015 recommendation. STUDY DESIGN: This was a prospective cohort study of term NV MSAF neonates who underwent immediate resuscitation without ET suctioning (no ET group, July 2018 to June 2019, n = 276) compared with historical control who underwent routine ET suction (ET group, July 2015 to June 2016, n = 271). RESULTS: Baseline characteristics revealed statistically significant higher proportion of male gender and small for gestational age neonates in the prospective cohort. There was no significant difference in the incidence of primary outcome of meconium aspiration syndrome (MAS) between the groups (no ET group: 27.2% vs ET group: 25.1%; p = 0.57). NV MSAF neonates with hypoxic ischemic encephalopathy (HIE) was significantly lesser in the prospective cohort (no ET group: 19.2% vs ET group: 27.3%; p = 0.03). Incidence of air leaks and need for any respiratory support significantly increased after policy change. In NV MSAF neonates with MAS, need for mechanical ventilation (MV) (no ET group: 24% vs ET group: 39.7%; p = 0.04) and mortality (no ET group: 18.7% vs ET group: 33.8%; p = 0.04) were significantly lesser. CONCLUSION: Current study from a developing country indicates that immediate resuscitation and no routine ET suctioning of NV MSAF may not be associated with increased risk of MAS and may be associated with decreased risk of HIE. Increased requirement of any respiratory support and air leak post policy change needs further deliberation. Decreased risk of MV and mortality among those with MAS was observed. KEY POINTS: · Not performing ET suction in NV MSAF infants is not associated with increase in the incidence of MAS.. · Initiating immediate resuscitation without ET suctioning was associated with decreased risk of HIE but increased receipt of any respiratory support and air leak.. · Large multicentric trial is required to generate robust evidence..

Tracheal suction at birth in non-vigorous neonates born through meconium-stained amniotic fluid.

BACKGROUND: Neonates born through meconium-stained amniotic fluid (MSAF) are at risk of developing meconium aspiration syndrome (MAS). Neonates who are non-vigorous due to intrapartum asphyxia are at higher risk of developing MAS. Clearance of meconium from the airways below the vocal cords by tracheal suction before initiating other steps of resuscitation may reduce the risk of development of MAS. However, conducting tracheal suction may not only be ineffective, it may also delay effective resuscitation, thus prolonging and worsening the hypoxic-ischaemic insult.  OBJECTIVES: To evaluate the efficacy of tracheal suctioning at birth in preventing meconium aspiration syndrome and other complications among non-vigorous neonates born through meconium-stained amniotic fluid. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 11) in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) (1946 to 25 November 2020) for randomised controlled trials (RCTs) and quasi-randomised trials. We also searched clinical trials databases and the reference lists of retrieved articles for RCTs and quasi-randomised trials (up to November 2020). SELECTION CRITERIA: We included studies enrolling non-vigorous neonates born through MSAF, if the intervention being tested included tracheal suction at the time of birth with an intent to clear the trachea of meconium before regular breathing efforts began. Tracheal suction could be performed with an endotracheal tube or a wide-gauge suction catheter. Neonates in the control group should have been resuscitated at birth with no effort made to clear the trachea of meconium. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data, consulting with a third review author about any disagreements. We used standard Cochrane methodological procedures, including assessment of risk of bias for all studies. Our primary outcomes were: MAS; all-cause neonatal mortality; and incidence of hypoxic-ischaemic encephalopathy (HIE). Secondary outcomes included: need for mechanical ventilation; incidence of pulmonary air leaks; culture-positive sepsis; and persistent pulmonary hypertension. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included four studies (enrolling 581 neonates) in the review. All four studies were conducted in tertiary care hospitals in India. Three of the four studies included neonates born at and beyond term gestation, whereas one included neonates born at and beyond 34 weeks of gestation. Due to the nature of the intervention, it was not possible to blind the healthcare personnel conducting the intervention. Tracheal suction compared to no suction in non-vigorous neonates born through MSAF In non-vigorous infants, no differences were noted in the risks of MAS (RR 1.00, 95% CI 0.80 to 1.25; RD 0.00, 95% CI -0.07 to 0.08; 4 studies, 581 neonates) or all-cause neonatal mortality (RR 1.24, 95% CI 0.76 to 2.02; RD 0.02, 95% CI -0.03 to 0.07; 4 studies, 575 neonates) with or without tracheal suctioning. No differences were reported in the risk of any severity HIE (RR 1.05, 95% CI 0.68 to 1.63; 1 study, 175 neonates) or moderate to severe HIE (RR 0.68, 95% CI 0.43 to 1.09; 1 study, 152 neonates) among non-vigorous neonates born through MSAF. We are also uncertain as to the effect of tracheal suction on other outcomes such as incidence of mechanical ventilation (RR 0.99, 95% CI 0.68 to 1.44; RD 0.00, 95% CI -0.06 to 0.06; 4 studies, 581 neonates), pulmonary air leaks (RR 1.22, 95% CI 0.38 to 3.93; RD 0.00, 95% CI -0.02 to 0.03; 3 studies, 449 neonates), persistent pulmonary hypertension (RR 1.29, 95% CI 0.60 to 2.77; RD 0.02, 95% CI -0.03 to 0.06; 3 studies, 406 neonates) and culture-positive sepsis (RR 1.32, 95% CI 0.48 to 3.57; RD 0.01, 95% CI -0.03 to 0.05; 3 studies, 406 neonates). All reported outcomes were judged as providing very low certainty evidence. AUTHORS' CONCLUSIONS: We are uncertain about the effect of tracheal suction on the incidence of MAS and its complications among non-vigorous neonates born through MSAF. One study awaits classification and could not be included in the review. More research from well-conducted large trials is needed to conclusively answer the review question.

Maintaining human milk bank services throughout the COVID-19 pandemic: A global response.

If maternal milk is unavailable, the World Health Organization recommends that the first alternative should be pasteurised donor human milk (DHM). Human milk banks (HMBs) screen and recruit milk donors, and DHM principally feeds very low birth weight babies, reducing the risk of complications and supporting maternal breastfeeding where used alongside optimal lactation support. The COVID-19 pandemic has presented a range of challenges to HMBs worldwide. This study aimed to understand the impacts of the pandemic on HMB services and develop initial guidance regarding risk limitation. A Virtual Collaborative Network (VCN) comprising over 80 HMB leaders from 36 countries was formed in March 2020 and included academics and nongovernmental organisations. Individual milk banks, national networks and regional associations submitted data regarding the number of HMBs, volume of DHM produced and number of recipients in each global region. Estimates were calculated in the context of missing or incomplete data. Through open-ended questioning, the experiences of milk banks from each country in the first 2 months of the pandemic were collected and major themes identified. According to data collected from 446 individual HMBs, more than 800,000 infants receive DHM worldwide each year. Seven pandemic-related specific vulnerabilities to service provision were identified, including sufficient donors, prescreening disruption, DHM availability, logistics, communication, safe handling and contingency planning, which were highly context-dependent. The VCN now plans a formal consensus approach to the optimal response of HMBs to new pathogens using crowdsourced data, enabling the benchmarking of future strategies to support DHM access and neonatal health in future emergencies.

A new clinical respiratory distress score for surfactant therapy in preterm infants with respiratory distress.

The guidelines for surfactant therapy are largely based on studies done in developed coun1tries wherein the facility infrastructure, patient profile, and clinical practices are different from low- and middle-income countries (LMICs). Though SRT is widely practiced in developing countries, there exists variability in clinical practice. Our objective was to identify the factors which would predict the need of surfactant administration and develop a "clinical respiratory distress (RD) score" for surfactant administration in preterm neonates with respiratory distress. A prospective observational study was conducted in 153 preterm infants (260/7 to 346/7 weeks gestation) with respiratory distress who were managed with CPAP and/or surfactant where indicated. Gestation < 32 weeks, no antenatal corticosteroid (ANS), hypothermia at admission, Apgar score < 3 at 1 minute, and Silverman score > 2 at 2 hours were found to be the significant factors in predicting surfactant requirement in multivariate regression analysis. A seven point scale was developed and categorized into two categories as < 4 and ≥ 4. The sensitivity, specificity, PPV, and NPV were 67%, 87%, 86%, and 68%, respectively, with a cutoff score ≥ 4. The positive likelihood ratio was 5.07 (95% CI 2.71-9.48), and negative likelihood ratio was 0.38 (95% CI 0.28-0.52). The observed rate of surfactant administration was found to be around 32% when the composite score was below four, and the rate increased to almost 86% when the composite score was ≥ 4. The predictive accuracy of the model was subsequently evaluated in a cohort of 56 preterm infants with respiratory distress.. Sensitivity, specificity and positive and negative predictive value during the validation phase were 97%, 73%, 85%, and 94%, respectively. With a composite score less than 4, the observed rate of surfactant administration was 6% (95% CI 1%-28%) as against the model predicted rate of 24%, while with composite score ≥ 4, the observed rate was 85% (95% CI 69%-94%) as against the model predicted rate of 90%.Conclusion: "Clinical RD score" is a simple score, which can be utilized for decision-making for early surfactant administration for preterm infants (260/7 to 346/7 weeks gestation) with respiratory distress.Trial Registration: NCT03273764What is Known:• Both CPAP and surfactant therapy are effective in management of preterm infants with RDS.• The efficacy of surfactant replacement therapy is better when it is administered early in the course of disease.What is New:• Many of the known risk factors for RDS do not predict surfactant requirement.• "Composite RD score" comprising of five independent predictors of surfactant requirement with a numeric cutoff may help decide which preterm neonates with respiratory distress need early surfactant administration in low- and middle-income countries.

Surfactant Lung Lavage vs. Standard Care in the Treatment of Meconium Aspiration Syndrome-A Randomized Trial.

OBJECTIVE: The objective of this study was to evaluate the effect of surfactant lung lavage (SLL) on duration of respiratory support in neonates with meconium aspiration syndrome (MAS). PATIENTS AND METHODS: Sixty term infants with MAS who had moderate to severe respiratory distress (Downes score >4) were randomized toSLL (n = 31) or no lung lavage-NLL (n = 29). Neonates in intervention group underwent lung lavage with dilute surfactant and those in control group were managed as per unit protocol. RESULTS: The median duration of respiratory support was 34 h in SLL group and 44 h in NLL group (p value = 0.994). The duration of oxygen therapy post-respiratory support decreased by 78% in SLL as compared with NLL group (4 vs. 18 h) (p value = 0.005). Lavage procedure was well tolerated with fall in mean heart rate by just 20/min and in mean saturation drop by just 6% during the procedure. CONCLUSION: Lung lavage is well tolerated by neonates, but it does not alter overall duration of respiratory support.

Factors Impacting Practice of Home Kangaroo Mother Care with Low Birth Weight Infants Following Hospital Discharge.

OBJECTIVE: To identify enablers and barriers related to home Kangaroo Mother Care (KMC) adoption after hospital discharge. STUDY DESIGN: An exploratory study, using a mixed methods evaluation, followed 60 mother-infant dyads from the hospital ward to 4 weeks post-hospital discharge. RESULTS: Fifty-three of the mothers (88.3%) completed all study visits. The majority of mothers were breastfeeding and practicing skin-to-skin contact 4 weeks post-discharge. Seven mothers (13.2%) discontinued skin-to-skin contact at 4 weeks. KMC was practiced on average 3.3 h/day and 5.1 days/week. The top two enablers reported were significantly related to the amount of time skin-to-skin was practiced, with support for household responsibilities being most significant (U = 195, p = 0.008). Lack of privacy (p = 0.002) and lack of motivation (p = 0.034) were negatively correlated to duration of skin-to-skin contact. CONCLUSION: Future programs may increase dissemination and adoption of home KMC by specifically addressing enablers and barriers correlated to duration of skin-to-skin contact.

A Pilot Study on Neonatal Surgical Mortality: A Multivariable Analysis of Predictors of Mortality in a Resource-Limited Setting.

PURPOSE: The aim of this research is to study the predictors of neonatal surgical mortality (NSM)-defined as in-hospital death or death within 30 days of neonatal surgery. MATERIALS AND METHODS: All neonates operated over the study period of 18 months were included to evaluate NSM. The evaluated preoperative and intraoperative variables were birth weight, gestation age, age at presentation, associated anomalies, site and duration of surgery, intraoperative blood loss, and temperature after surgery. Assessed postoperative variables included the need for vasopressors, postoperative ventilation, sepsis, reoperations, and time taken to achieve full enteral nutrition. Univariate and multivariate logistic regression was applied to find the predictors of mortality. RESULTS: Based on patient's final outcome, patients were divided into two groups (Group 1-survival, n = 100 and Group 2-mortality, n = 50). Incidence of NSM in this series was 33.33%. Factors identified as predictors of NSM were duration of surgery >120 min (P = 0.007, odds ratio [OR]: 9.76), need for prolonged ventilation (P = 0.037, OR: 5.77), requirement of high dose of vasopressors (P = 0.003, OR: 25.65) and reoperations (P = 0.031, OR: 7.16 (1.20-42.81). CONCLUSION: NSM was largely dependent on intraoperative stress factors and postoperative care. Neonatal surgery has a negligible margin of error and warrants expertize to minimize the duration of surgery and complications requiring reoperations. Based on our observations, we suggest a risk stratification score for neonatal surgery.

Healthcare workers' views on the use of continuous positive airway pressure (CPAP) in neonates: a qualitative study in Andhra Pradesh, India.

BACKGROUND: Continuous Positive Airway Pressure (CPAP) is a form of non-invasive ventilatory support which is increasingly used in low- and middle-income countries to treat neonates with acute respiratory distress. However, it may be harmful if used incorrectly. We aimed to explore the experiences of doctors and nurses using CPAP in neonatal units in India and their views on enablers and barriers to implementation of CPAP. METHODS: Participants from 15 neonatal units across Andhra Pradesh were identified through purposive sampling. Eighteen in-depth interviews (IDI) with doctors and eight focus group discussions (FGD) with 51 nurses were conducted. Data were analysed thematically using the framework approach. RESULTS: Common structural factors that limit the use of CPAP include shortages of staff, consumables and equipment, and problems with regard to the organisation of neonatal units in both district hospitals and medical colleges. This meant that CPAP was often not available for babies who were identified to need CPAP, or that CPAP use was not perceived to be of the highest quality. Providing care under constrained circumstances left staff feeling powerless to provide good quality care for neonates with acute respiratory distress. Despite this, staff were enthusiastic about the use of CPAP and its potential to save lives. CPAP use was mostly perceived as technically easier to provide than ventilation and allowed nurses to provide advanced neonatal care, independently of doctors. CONCLUSIONS: Doctors and nurses embraced CPAP use but identified barriers to implementation which will need to be addressed in order not to impact on safety and quality of care. Ensuring a supportive and enabling environment is in place will be crucial if CPAP is to be scaled-up more widely.

Approach to Infants Born Through Meconium Stained Amniotic Fluid: Evolution Based on Evidence?

Meconium-stained amniotic fluid (MSAF) during delivery is a marker of fetal stress. Neonates born through MSAF often need resuscitation and are at risk of meconium aspiration syndrome (MAS), air leaks, hypoxic-ischemic encephalopathy, extracorporeal membrane oxygenation (ECMO), and death. The neonatal resuscitation approach to MSAF has evolved over the last three decades. Previously, nonvigorous neonates soon after delivery were suctioned under the vocal cords with direct visualization technique using a meconium aspirator. The recent neonatal resuscitation program (NRP) recommends against suctioning but favors resuscitation with positive pressure ventilation of nonvigorous neonates with MSAF. This recommendation is aimed to prevent delay in resuscitation and minimize hypoxia-ischemia often associated with MSAF. In this review, we discuss the pathophysiology, evolution and the evidence, randomized control trials, observational studies, and translational research to support these recommendations. The frequency of ECMO use for neonatal respiratory indication of MAS has declined over the years probably secondary to improvements in neonatal intensive care and reduction of postmaturity. Changes in resuscitation practices may have contributed to reduced incidence and severity of MAS. Larger randomized controlled studies are needed among nonvigorous infants with MSAF. However, ethical dilemmas and loss of equipoise pose a challenge to conduct such studies.

Early Total Enteral Feeding in Stable Very Low Birth Weight Infants: A Before and After Study.

Background: Fear of necrotizing enterocolitis (NEC) has perpetuated delayed initiation and slow advancement of enteral feeding in very low birth weight (VLBW) infants with inherent risks of parenteral alimentation. The objective of this study was to assess effect of early total enteral feeding (ETEF) on day of achievement of full enteral feeds, feed intolerance, NEC and sepsis. Methods: In total, 208 stable VLBW neonates (28-34 weeks) admitted during 6 month periods of three consecutive years were enrolled. First phase (n = 73) constituted the 'before' phase with standard practice of initial intravenous fluid therapy and slow enteral feeding. The second prospective phase (n = 51) consisted of implementation of ETEF with infants receiving full enteral feeds as per day's fluid requirement since Day 1 of life. The third phase (n = 84) was chosen to assess the sustainability of change in practice. Results: Day of achievement of full feeds was significantly earlier in Phases 2 and 3 compared with Phase 1 (8.97 and 5.47 vs. 14.44 days, respectively, p = 0.0001). Incidence of feed intolerance was comparable between Phases 1 and 2 (22 vs. 14%, p = 0.28), with marked reduction in incidence of NEC (14 vs. 4%, p = 0.028). There was a significant decrease in sepsis, duration of parenteral fluid and antibiotic therapy as well as hospital stay with comparable mortality. Conclusion: In stable preterm VLBW infants, ETEF is safe and has the benefit of optimizing nutrition with decrease in sepsis, NEC and hospital stay.

Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study.

BACKGROUND: Infections are the single most important cause of neonatal mortality in developing countries. Results from trials in Asia evaluating the effect of chlorhexidine on neonatal mortality have been encouraging but limited data are available on the impact of cord cleansing on bacterial colonization. Further, no data from facility deliveries and impact with time is available. This pilot study was aimed to evaluate the impact of 4 % commercially prepared chlorhexidine on cord colonization and density of colonization among newborns in India. METHODS: Three hundred twenty-six newborns (hospital-247; community-79) were enrolled within 24 h of birth and randomly assigned to one of three groups: chlorhexidine, placebo or dry cord care. Umbilical swabs were collected at baseline, 2- and 48- hours after intervention application. RESULTS: At baseline, growth positivity (any bacterial growth) was 20 % (50 of 247 swabs) and 81 % (64 of 79 swabs) among hospital and community born neonates, respectively. In both settings, chlorhexidine compared to placebo and dry cord care, reduced colonization following 2- and 48-hour post application. Chlorhexidine significantly reduced 48-hour post application colony counts in comparison to placebo [Hospital: mean difference = -1.01; 95 % CI: -1.72, -0.30 Community: mean difference = -1.76; 95 % CI: -2.60, -0.93] and dry cord care [Hospital: mean difference = -1.16; 95 % CI: -1.93, -0.39 Community: mean difference = -2.23; 95 % CI: -3.18, -1.29]. Differences were similar for gram-positive and gram-negative bacteria. CONCLUSIONS: Cord cleansing with 4 % chlorhexidine soon after birth reduced colonization as well as density of colonization significantly; however this pilot study does not address the impact of chlorhexidine on mortality. The control preparation neither increased or decreased colonization. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT01528852, Registered February 7, 2012.

Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)--a randomized controlled trial.

UNLABELLED: The objective of the study was to evaluate the effect of administering prophylactic antibiotics on the development of neonatal sepsis in term neonates born through meconium-stained amniotic fluid (MSAF). Two hundred and fifty eligible neonates were randomized to study group (Antibiotic group-receiving first-line antibiotics for 3 days) and control group (No Antibiotic group). Both groups were evaluated clinically and by laboratory parameters (sepsis screen and blood cultures) for development of sepsis. All neonates were monitored for respiratory, neurological, and other systemic complications and received supportive treatment according to standard management protocol of the unit. One hundred and twenty one neonates were randomized to 'Antibiotic' group and 129 to 'No Antibiotic' group. The overall incidence of suspect sepsis was 9.6 % in the study population with no significant difference between 'No Antibiotic' and 'Antibiotic' groups (10.8 vs. 8.2 %, p = 0.48, odds ratio (OR) 0.74, 95 % confidence interval (CI) 0.32-1.73). Incidence of culture-proven sepsis was also not significantly different between the two groups (5.42 vs. 4.13 %, p = 0.63, OR 0.75, 95 % CI 0.23-2.43). The incidence of mortality, meconium aspiration syndrome, and other complications was comparable amongst the two groups. CONCLUSION: Routine antibiotic prophylaxis in neonates born through MSAF did not reduce the incidence of sepsis in this study population. (Clinicaltrials.gov no. - NCT01290003).

Topical Oil Application and Trans-Epidermal Water Loss in Preterm Very Low Birth Weight Infants-A Randomized Trial.

OBJECTIVE: Topical emollient application reduces trans-epidermal water loss (TEWL) in preterm neonates. Coconut oil used traditionally for infant massage in India has not been evaluated for the same. PATIENTS AND METHODS: Very low birth weight (VLBW) neonates were randomized at 12 h of age to Oil (n = 37) or Control (n = 37) groups. Oil group neonates received twice-daily coconut oil application without massage, and Control group received standard care. TEWL was measured every 12 h using an evaporimeter till Day 7 when skin swabs were obtained for bacterial growth and skin condition was assessed using a validated score. RESULTS: Birth weight (g; mean ± SD: 1213 + 214 vs. 1164 + 208, p = 0.31), gestation [week; median (interquartile range): 32 (31-33) vs. 32 (29-33), p = 0.10] and other baseline variables were comparable. TEWL was significantly reduced (g/m(2)/h, mean difference: -6.80, 95% confidence interval: -3.48, -10.15; p < 0.01) with better skin condition and lower bacterial growth in the Oil group (20% vs. 60%, p < 0.01). CONCLUSION: Coconut oil application reduced TEWL without increasing skin colonization in VLBW neonates. CLINICAL TRIALS REGISTRATION: NCT01758068.

Influence of Early Total Enteral Feeding in Preterm Infants with Respiratory Distress Syndrome.

INTRODUCTION: Providing adequate nutrition in the management of preterm infants has been challenging. The objective of this secondary analysis of data from the randomized trial comparing "less invasive surfactant therapy (LISA) with InSurE method of surfactant administration" is to demonstrate the feasibility of early total enteral feeding (ETEF) in hemodynamically stable preterm neonates on respiratory support and to examine the factors associated with failure of ETEF. METHODS: Secondary analysis of a randomized controlled trial comparing "LISA versus InSurE among preterm infants between 26 and 34 weeks of gestation" enrolled 150 infants with 117 being hemodynamically stable. ETEF without any parenteral supplementation was started on day 1 of life using the mother's own milk (MoM) or donor human milk (<32 weeks of GA) and MoM or preterm formula (33-34 weeks of GA). The data were analyzed to assess the proportion of babies developing feed intolerance and/or necrotizing enterocolitis (NEC) and factors associated with failure of ETEF. All Infants were assessed for the day of attainment of full enteral feeding defined as receiving and tolerating 150 mL/kg of enteral feeds per day. RESULTS: Out of these 117 babies, 102 tolerated ETEF, and 15 had one or more episodes of FI requiring total parenteral nutrition, but none developed NEC till discharge or death. On the assessment of possible factors associated with ETEF failure, there were no differences in baseline characteristics but statistically significantly increased incidence of culture-positive sepsis as well as the requirement of antibiotic therapy for possible sepsis (early as well as late-onset sepsis) in babies with failure of ETEF. The babies who tolerated ETEF achieved full enteral feeding (150 mL/kg/day) significantly earlier (5.48 ± 1.1 days) compared to those with ETEF failure (7 ± 3.4 days) (p 0.001). The time to regain birth weight was earlier in the ETEF group without significant differences in growth parameters. There was also a reduction in the duration of hospital stay in babies who tolerated ETEF, but both these results were not statistically significant. CONCLUSION: ETEF is feasible in preterm neonates with respiratory distress syndrome who are on respiratory support. It resulted in earlier attainment of full enteral feeds and decreased the incidence of sepsis with reduced antibiotic usage.