Feasibility, Sustainability, and Effectiveness of the Implementation of "Facility-Team-Driven" Approach for Improving the Quality of Newborn Care in South India.

OBJECTIVES: The primary objective of the study was to assess the feasibility and sustainability of the implementation of the point of care quality improvement (POCQI) methodology for improving the quality of neonatal care at the level 2 special newborn care unit (SNCU). Additional objective was to evaluate the effectiveness of the quality improvement (QI) and preterm baby package training model. METHODS: This study was conducted in a level-II SNCU. The study period was divided into baseline; intervention and sustenance phases. The primary outcome i.e., feasibility was defined as completion of training for 80% or more health care professionals (HCPs) through workshops, their attendance in subsequent review meetings and, successful accomplishment of at least two plan-do-study-act (PDSA) cycles in each project. RESULTS: Of the total, 1217 neonates were enrolled during the 14 mo study period; 80 neonates in the baseline, 1019 in intervention and 118 in sustenance phases. Feasibility of training was achieved within a month of initiation of intervention phase; 22/24 (92%) nurses and 14/15 (93%) doctors attended the meetings. The outcomes of individual projects suggested an improvement in proportion of neonates being given exclusive breast milk on day 5 (22.8% to 78%); mean difference (95% CI) [55.2 (46.5 to 63.9)]. Neonates on any antibiotics declined, proportion of any enteral feeds on day one and duration of kangaroo mother care (KMC) increased. Proportion of neonates receiving intravenous fluids during phototherapy decreased. CONCLUSIONS: The present study demonstrates the feasibility, sustainability, and effectiveness of a facility-team-driven QI approach augmented with capacity building and post-training supportive supervision.

Periodic change of body position under phototherapy in term and preterm neonates with hyperbilirubinaemia.

BACKGROUND: Phototherapy is the mainstay of treatment of neonatal hyperbilirubinaemia. Periodic change in position of the neonate under phototherapy (from supine to prone or lateral positions) may improve the efficiency of phototherapy by hastening the access of phototherapy light to bilirubin deposited in different parts of the skin and subcutaneous tissue. OBJECTIVES: To evaluate the effects of periodic change of body position during phototherapy as compared to no prescribed change in body position, on serum total bilirubin level and duration of treatment in neonates with unconjugated hyperbilirubinaemia during the first 28 days of life. Secondary objectives of the review included evaluation of the efficacy of periodic change of body position on the need for or number of exchange transfusions, incidence of bilirubin-induced neurological damage (BIND), side effects of phototherapy, and sudden infant death syndrome (SIDS). SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to run comprehensive searches in the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 3) in the Cochrane Library and Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions on 5 March 2021. We also searched clinical trials databases and the reference lists of included studies and relevant reviews for randomised controlled trials (RCTs) and quasi-RCTs. SELECTION CRITERIA: We included RCTs and quasi-RCTs if they enrolled neonates (term and preterm) of either gender with unconjugated hyperbilirubinaemia requiring phototherapy and compared periodic change of the body position of the infant under phototherapy with no prescribed change in body position. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data, consulting with a third review author in the case of disagreement. We used standard Cochrane methodological procedures, including assessing the risk of bias of included studies. We used the GRADE approach to assess the certainty of evidence. Primary outcomes were the duration of phototherapy and rate of fall of serum bilirubin at 24 hours. Secondary outcomes included the need for exchange transfusion, number of exchange transfusions, incidence of BIND, and SIDS. MAIN RESULTS: We included five studies (343 neonates) with an overall high risk of bias in the review. The body position under phototherapy was changed every two hours or every two-and-a-half hours in two studies each, and every three hours in one study. Three of the five studies included healthy term neonates, whilst the other two studies also included preterm neonates (≥ 33 weeks' gestation); however, separate data about review outcomes in preterm neonates were not available. Periodic change in body position may lead to little or no difference in the duration of phototherapy (mean difference (MD) 1.71 hours, 95% confidence interval (CI) -3.17 to 6.59 hours; I² = 58%; 4 studies, 231 participants; low certainty evidence). Only one study reported the rate of fall of serum total bilirubin at 24 hours of starting the phototherapy. Periodic change in body position may lead to little or no difference in the rate of fall of serum total bilirubin at 24 hours (MD 0.02 mg/dL/h, 95% CI -0.02 to 0.06 mg/dL/h; 1 study, 100 participants; low certainty evidence). We downgraded the certainty of evidence to low due to risk of bias and imprecision. None of the included studies reported the need for or number of exchange transfusions, incidence of BIND, or SIDS. Lack of separate data precluded subgroup analysis. AUTHORS' CONCLUSIONS: The available evidence is insufficient to determine the effects of periodic change of body position compared with no prescribed change of body position under phototherapy. There is low certainty evidence that there may be little or no difference in the duration of phototherapy and rate of fall in bilirubin at 24 hours of starting phototherapy between periodic change in body position and no prescribed change of body position under phototherapy in term and preterm neonates. None of the included studies reported the effect of change of position on the need for or number of exchange transfusions, incidence of BIND, or SIDS. One study is awaiting classification and could not be included in the review. Further studies are needed to evaluate the effect of periodic change in body position under phototherapy, especially in neonates with haemolytic hyperbilirubinaemia and in very preterm neonates. The results of this systematic review apply mainly to neonates born at late-preterm or term gestation receiving phototherapy for non-haemolytic hyperbilirubinaemia.

Fortification of Breast Milk With Preterm Formula Powder vs Human Milk Fortifier in Preterm Neonates: A Randomized Noninferiority Trial.

Importance: Fortification of expressed breast milk (EBM) using commercially available human milk fortifiers (HMF) increases short-term weight and length in preterm very low-birth-weight (VLBW) neonates. However, the high cost and increased risk of feed intolerance limit their widespread use. Preterm formula powder fortification (PTF) might be a better alternative in resource-limited settings. Objective: To demonstrate that fortification of EBM by preterm formula powder is noninferior to fortification by HMF, in terms of short-term weight gain, in VLBW neonates. Design, Setting, and Participants: Open-label, noninferiority, randomized trial conducted from December 2017 to June 2019 at a level 3 neonatal unit in India. The trial enrolled preterm (born at or before 34 weeks of gestation) VLBW neonates receiving at least 100 mL/kg/d of feeds and consuming 75% of milk or more as EBM. Interventions: Neonates were randomly assigned to receive fortification by either PTF or HMF. Calcium, phosphorus, iron, vitamin D, and multivitamins were supplemented in PTF and only vitamin D in the HMF group to meet the recommended dietary allowances. Main Outcomes and Measures: The primary outcome was the weight gain until discharge from the hospital or 40 weeks' postmenstrual age, whichever was earlier; the prespecified noninferiority margin was 2 g/kg/d. Secondary outcomes included morbidities such as necrotizing enterocolitis, feed intolerance, and extrauterine growth restriction (<10th percentile on the Fenton chart at 40 weeks' postmenstrual age). Results: Of the 123 neonates enrolled, 60 and 63 were randomized to the PTF and HMF groups, respectively. The mean gestation (30.5 vs 29.9 weeks) and birth weight (1161 vs 1119 g) were comparable between the groups. There was no difference in the mean (SD) weight gain between the PTF and HMF groups (15.7 [3.9] vs 16.3 [4.0] g/kg/d; mean difference, -0.5 g/kg/d; 95% CI, -1.9 to 0.7). The lower bound of 95% CI did not cross the noninferiority margin. The incidence of feed intolerance was lower in the PTF group (1.4 vs 6.8 per 1000 patient-days; incidence rate ratio 0.19; 95% CI, 0.04 to 0.95), and fewer neonates required withholding of fortification for 24 hours or more (5% vs 22%; risk ratio, 0.22; 95% CI, 0.07 to 0.75). The incidence of necrotizing enterocolitis stage II or more (0 vs 5%) and extrauterine growth restriction (73% vs 81%) was comparable between the groups. Conclusions and Relevance: Fortification with preterm formula powder is not inferior to fortification with human milk fortifiers in preterm neonates. Given the possible reduction in feed intolerance and lower costs, preterm formula might be a better option for fortification, especially in resource-restricted settings. Trial Registration: Clinical Trial Registry, India Identifier: CTRI/2017/11/010593.

Effect of Umbilical Cord Milking vs Delayed Cord Clamping on Venous Hematocrit at 48 Hours in Late Preterm and Term Neonates: A Randomized Controlled Trial.

OBJECTIVE: To compare the effect of intact umbilical cord milking (MUC) and delayed cord clamping (DCC) on venous hematocrit at 48 (±6) hours in late preterm and term neonates (350/7- 426/7 wk). STUDY DESIGN: Randomized trial. SETTING AND PARTICIPANTS: All late preterm and term neonates (350/7 - 426/7 wk) neonates born in the labor room and maternity operation theatre of tertiary care unit were included. INTERVENTION: We randomly allocated enrolled neonates to MUC group (cord milked four times towards the baby while being attached to the placenta; n=72) or DCC group (cord clamped after 60 seconds; n=72). OUTCOME: Primary outcome was venous hematocrit at 48 (±6) hours of life. Additional outcomes were venous hematocrit at 48 (±6) hours in newborns delivered through lower segment caesarean section (LSCS), incidence of polycythemia requiring partial exchange transfusion, incidence of hyperbilirubinemia requiring phototherapy, and venous hematocrit and serum ferritin levels at 6 (±1) weeks of age. RESULTS: The mean (SD) hematocrit at 48 (±6) hours in the MUC group was higher than in DCC group [57.7 (4.3) vs. 55.9 (4.4); P=0.002]. Venous hematocrit at 6 (±1) weeks was higher in MUC than in DCC group [mean (SD), 37.7 (4.3) vs. 36 (3.4); mean difference 1.75 (95% CI 0.53 to 2.9); P=0.005]. Other parameters were similar in the two groups. CONCLUSION: MUC leads to a higher venous hematocrit at 48 (±6) hours in late preterm and term neonates when compared with DCC.

Delayed cord clamping in Rh-alloimmunised infants: a randomised controlled trial.

Despite advancement in medical care, Rh alloimmunisation remains a major cause of neonatal hyperbilirubinaemia, neuro-morbidity, and late-onset anaemia. Delayed cord clamping (DCC), a standard care now-a-days, is yet not performed in Rh-alloimmunised infants due to paucity of evidence. Hence, we randomised these infants of 28- to 41-week gestation to delayed cord clamping (N = 36) or early cord clamping (N = 34) groups. The primary outcome variable was venous packed cell volume (PCV) at 2 h of birth. The secondary outcomes were incidence of double volume exchange transfusion (DVET) and partial exchange transfusion (PET), duration of phototherapy (PT), functional echocardiography (parameters measured: superior vena cava flow, M-mode fractional shortening, left ventricular output, myocardial perfusion index, and inferior vena cava collapsibility) during hospital stay, and blood transfusion (BT) until 14 weeks of life. Neonates were managed as per unit protocol. The baseline characteristics of enrolled infants were comparable between the groups. The median (IQR) gestation and mean (SD) birth weight of enrolled infants were 35 (33-37) weeks and 2440 (542) g, respectively. The DCC group had a higher mean PCV at 2 h of life (48.4 ± 9.2 vs. 43.5 ± 8.7, mean difference 4.9% (95% CI 0.6-9.1), p = 0.03). However, incidence of DVET and PET, duration of PT, echocardiography parameters, and BT until 14 weeks of postnatal age were similar between the groups.Conclusion: DCC in Rh-alloimmunised infants improved PCV at 2 h of age without significant adverse effects.Trial registration: Clinical Trial Registry of India (CTRI), Ref/2016/11/012572 http://ctri.nic.in/Clinicaltrials, date of trial registration 19.12.2016, date of first patient enrolment 1 January 2017.What is Known:•Delayed cord clamping improves haematocrit, results in better haemodynamic stability, and decreases the need of transfusion in early infancy.•However, due to lack of evidence, potential risk of hyperbilirubinaemia, and exacerbation of anaemia (following delayed cord clamping), early cord clamping is the usual norm in Rh-alloimmunised infantsinfants.What is New:•Delayed cord clamping in Rh-alloimmunised infants improves haematocrit at 2 h of life without any increase in incidence of serious adverse effects.

Helping Babies Breathe, Second Edition: A Model for Strengthening Educational Programs to Increase Global Newborn Survival.

BACKGROUND: Helping Babies Breathe (HBB), a skills-based program in neonatal resuscitation for birth attendants in resource-limited settings, has been implemented in over 80 countries since 2010. Implementation studies of HBB incorporating low-dose high-frequency practice and quality improvement show substantial reductions in fresh stillbirth and first-day neonatal mortality. Revision of the program aimed to further augment provider and facilitator skills and address gaps in implementation with the goal of improving neonatal survival. METHODS: The Utstein Formula for Survival-Medical Science X Educational Efficiency X Local Implementation = Survival-provided a framework for the revisions. The 2015 Neonatal Resuscitation Consensus on Science and Treatment Recommendations by the International Liaison Committee on Resuscitation informed scientific updates, which were harmonized with the 2012 World Health Organization Basic Newborn Resuscitation Guidelines. Published literature and program reports, consensus guidelines on reprocessing equipment, systematic collection of suggestions from frontline users, and responses to a semistructured online questionnaire informed educational/implementation revisions. Links to maternal care were added. Draft materials underwent Delphi review and field testing in India and Sierra Leone. An Utstein-style meeting of stakeholders identified key actions for successful implementation. RESULTS: Scientific revisions included expectant management of infants with meconium-stained amniotic fluid, limitation of suctioning, and initiating and continuing effective ventilation until spontaneous respirations. Frontline users (N=102) suggested augmented simulation methods to build confidence and competence and additional guidance for facilitators on implementation. Users identified a need for sufficient practice during the workshop, systematized ongoing practice, and enough simulators for participants. Field trials refined approaches to self-reflection, feedback and debriefing, and quality improvement. Utstein meeting stakeholders validated the importance of quality improvement and use of data to improve outcomes. CONCLUSIONS: The second edition of HBB provides a newer paradigm of learning for providers that incorporates workshop practice, self-reflection, and feedback and debriefing to reinforce learning as well as the promotion of mentorship and development of facilitators, systems for low-dose high-frequency practice in facilities, and quality improvement related to neonatal resuscitation.

Efficacy of daily supplementation of 800 IU vitamin D on vitamin D status at 6 months of age in term healthy Indian infants.

OBJECTIVES: Most authorities recommend daily supplementation of 400 IU vitamin D for all term healthy neonates throughout infancy, however this dose was shown to be inadequate in an earlier study from our institution. We planned to evaluate if supplementation of 800 IU/day in term Indian infants would reduce the prevalence of vitamin D insufficiency (VDI) at 6 months of age. METHODS: In a prospective study, we supplemented 800 IU/day of vitamin D in 70 term infants from birth till 6 months of age. Serum 25-hydroxy cholecalciferol [25(OH)D] was measured at birth and 6 months for all infants; and at 6, 10 and 14 weeks of age in subsets of 23 infants each. The primary outcome was prevalence of VDI (defined as serum 25(OH)D level < 50 nmol/L) at 6 months of age. RESULTS: A total of 58 out of 70 (83%) infants were followed up until 6 months of age. The median (nmol/L; IQR) serum 25(OH)D at birth and 6 months of age was 25 (12.5-35) and 92.5 (72.5-137.5), respectively. The prevalence of VDI at birth was 91.3% (63/69), which reduced to 6.9% (4/58) at 6 months of age. However, four infants (6.9%, 95% CI 1.9-16.7) developed vitamin D excess (serum 25(OH)D 250-375 nmol/L) requiring reduction of the dose of supplementation. No infant developed vitamin D toxicity (serum 25(OH)D > 375 nmol/L). CONCLUSIONS: Daily supplementation of 800 IU of vitamin D resulted in vitamin D sufficiency in most term healthy infants at 6 months of age but with potential risk of toxicity.

Complementary feeding at 4 versus 6 months of age for preterm infants born at less than 34 weeks of gestation: a randomised, open-label, multicentre trial.

BACKGROUND: Evidence on the optimal time to initiation of complementary feeding in preterm infants is scarce. We examined the effect of initiation of complementary feeding at 4 months versus 6 months of corrected age on weight for age at 12 months corrected age in preterm infants less than 34 weeks of gestation. METHODS: In this open-label, randomised trial, we enrolled infants born at less than 34 weeks of gestation with no major malformation from three public health facilities in India. Eligible infants were tracked from birth and randomly assigned (1:1) at 4 months corrected age to receive complementary feeding at 4 months corrected age (4 month group), or continuation of milk feeding and initiation of complementary feeding at 6 months corrected age (6 month group), using computer generated randomisation schedule of variable block size, stratified by gestation (30 weeks or less, and 31-33 weeks). Iron supplementation was provided as standard. Participants and the implementation team could not be masked to group assignment, but outcome assessors were masked. Primary outcome was weight for age Z-score at 12 months corrected age (WAZ12) based on WHO Multicentre Growth Reference Study growth standards. Analyses were by intention to treat. The trial is registered with Clinical Trials Registry of India, number CTRI/2012/11/003149. FINDINGS: Between March 20, 2013, and April 24, 2015, 403 infants were randomly assigned: 206 to receive complementary feeding from 4 months and 197 to receive complementary feeding from 6 months. 22 infants in the 4 month group (four deaths, two withdrawals, 16 lost to follow-up) and eight infants in the 6 month group (two deaths, six lost to follow-up) were excluded from analysis of primary outcome. There was no difference in WAZ12 between two groups: -1·6 (SD 1·2) in the 4 month group versus -1·6 (SD 1·3) in the 6 month group (mean difference 0·005, 95% CI -0·24 to 0·25; p=0·965). There were more hospital admissions in the 4 month group compared with the 6 month group: 2·5 episodes per 100 infant-months in the 4 month group versus 1·4 episodes per 100 infant-months in the 6 month group (incidence rate ratio 1·8, 95% CI 1·0-3·1, p=0·03). 34 (18%) of 188 infants in the 4 month group required hospital admission, compared with 18 (9%) of 192 infants in the 6 month group. INTERPRETATION: Although there was no evidence of effect for the primary endpoint of WAZ12, the higher rate of hospital admission in the 4 month group suggests a recommendation to initiate complementary feeding at 6 months over 4 months of corrected age in infants less than 34 weeks of gestation. FUNDING: Indian Council of Medical Research supported the study until Nov 14, 2015. Subsequently, Shuchita Gupta's salary was supported for 2 months by an institute fellowship from All India Institute Of Medical Sciences, and a grant by Wellcome Trust thereafter.

Iron Stores in Term and Late Preterm Small for Gestational Age and Appropriate for Gestational Age Neonates at Birth and in Early Infancy.

OBJECTIVE: To compare body iron stores in late preterm and term small for gestational age (SGA) infants with gestation matched appropriate-for-gestational age (AGA) infants at birth and at 2 mo of age. METHODS: In this prospective observational study, live births of 34-42 wk gestation and SGA (<10th centile for GA) were enrolled along with gestation matched AGA (10th-90th centile for GA) infants. Infants' blood samples were taken within 2 h of delivery, and repeated at 60 ± 7 d of life. Primary outcome was serum ferritin at birth and 60 d of age. Secondary outcomes were hematocrit at birth and 60 d and need for transfusion until 60 d of life. RESULTS: A total of 37 SGA (gestation 37.2 ± 1.9 wk, birth weight 1861 ± 401 g) and 30 AGA infants (gestation 37.3 ± 1.9 wk, birth weight 2607 ± 405 g) were enrolled in the study. There was no difference in the serum ferritin between AGA and SGA infants at birth {median [IQR]: 254.0 [214.3-293.8] vs. 259.7 [217.8-301.5] µg/L; p = 0.85} or 60 d of life {147.2 [101.4-193.0] vs. 155.0 [106.6-203.6] µg/L; p = 0.81}. Mean hematocrit was 55.5 ± 9.6 vs. 52.4 ± 5.0 at birth (p = 0.10) and 32.1 ± 4.9 vs. 31.6 ± 3.8 at 60 d (p = 0.77) in SGA and AGA infants respectively. No infant required blood transfusion during the study period. CONCLUSIONS: Iron stores of late preterm and term SGA infants are comparable to term AGA infants at birth and 2 mo of age. Recommendations on iron supplementation to these infants need to be formulated through appropriately designed randomized trials.

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.

Inpatient care of small and sick newborns: a multi-country analysis of health system bottlenecks and potential solutions.

BACKGROUND: Preterm birth is the leading cause of child death worldwide. Small and sick newborns require timely, high-quality inpatient care to survive. This includes provision of warmth, feeding support, safe oxygen therapy and effective phototherapy with prevention and treatment of infections. Inpatient care for newborns requires dedicated ward space, staffed by health workers with specialist training and skills. Many of the estimated 2.8 million newborns that die every year do not have access to such specialised care. METHODS: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the Every Newborn Action Plan process. Country workshops involved technical experts to complete the survey tool, which is designed to synthesise and grade health system "bottlenecks" (or factors that hinder the scale up) of maternal-newborn intervention packages. For this paper, we used quantitative and qualitative methods to analyse the bottleneck data, and combined these with literature review, to present priority bottlenecks and actions relevant to different health system building blocks for inpatient care of small and sick newborns. RESULTS: Inpatient care of small and sick newborns is an intervention package highlighted by all country workshop participants as having critical health system challenges. Health system building blocks with the highest graded (significant or major) bottlenecks were health workforce (10 out of 12 countries) and health financing (10 out of 12 countries), followed by community ownership and partnership (9 out of 12 countries). Priority actions based on solution themes for these bottlenecks are discussed. CONCLUSIONS: Whilst major bottlenecks to the scale-up of quality inpatient newborn care are present, effective solutions exist. For all countries included, there is a critical need for a neonatal nursing cadre. Small and sick newborns require increased, sustained funding with specific insurance schemes to cover inpatient care and avoid catastrophic out-of-pocket payments. Core competencies, by level of care, should be defined for monitoring of newborn inpatient care, as with emergency obstetric care. Rather than fatalism that small and sick newborns will die, community interventions need to create demand for accessible, high-quality, family-centred inpatient care, including kangaroo mother care, so that every newborn can survive and thrive.

Oral zinc for the prevention of hyperbilirubinaemia in neonates.

BACKGROUND: Between 6% and 15% of neonates develop hyperbilirubinaemia requiring treatment. Successful management of neonatal hyperbilirubinaemia relies on prevention and early treatment, with phototherapy being the mainstay of treatment. Oral zinc has been reported to decrease the serum total bilirubin (STB), presumably by decreasing the enterohepatic circulation. OBJECTIVES: To determine the effect of oral zinc supplementation compared to placebo or no treatment on the incidence of hyperbilirubinaemia in neonates during the first week of life and to assess the safety of oral zinc in enrolled neonates. SEARCH METHODS: We searched CENTRAL (The Cochrane Library 2014, Issue 1), MEDLINE (1966 to November 30, 2014), and EMBASE (1990 to November 30, 2014). SELECTION CRITERIA: Randomised controlled trials were eligible for inclusion if they enrolled neonates (term and preterm) to whom oral zinc, in a dose of 10 to 20 mg/day, was initiated within the first 96 hours of life, for any duration until day seven, compared with no treatment or placebo. DATA COLLECTION AND ANALYSIS: We used the standard methods of The Cochrane Collaboration and its Neonatal Review Group for data collection and analysis. MAIN RESULTS: Only one study met the criteria of inclusion in the review. This study compared oral zinc with placebo. Oral zinc was administered in a dose of 5 mL twice daily from day 2 to day 7 postpartum. The drug was administered into the mouth of the infant by the plastic measure provided with the bottle or with a spoon. Incidence of hyperbilirubinaemia, defined as serum total bilirubin (STB) ≥ 15 mg/dL, was similar between groups (N = 286; risk ratio (RR) 0.94, 95% confidence interval (CI) 0.58 to 1.52). Mean STB levels, mg/dL, at 72 ± 12 hours were comparable in both the groups (N = 286; mean difference (MD) -0.20; 95% CI -1.03 to 0.63). Although the duration of phototherapy in the zinc group was significantly shorter compared to the placebo group (N = 286; MD -12.80, 95% CI -16.93 to -8.67), the incidence of need for phototherapy was comparable across both the groups (N = 286; RR 1.20; 95% CI 0.66 to 2.18). Incidences of side effects like vomiting (N = 286; RR 0.65, 95% CI 0.19 to 2.25), diarrhoea (N = 286; RR 2.92, 95% CI 0.31 to 27.71), and rash (N = 286; RR 2.92, 95% CI 0.12 to 71.03) were found to be rare and statistically comparable between groups. AUTHORS' CONCLUSIONS: The limited evidence available has not shown that oral zinc supplementation given to infants up to one week old reduces the incidence of hyperbilirubinaemia or need for phototherapy.

E-learning in newborn health - a paradigm shift for continuing professional development for doctors and nurses.

Neonatal mortality can be largely prevented by wide-scale coverage of components of essential newborn care and management of sick neonates in district-level healthcare facilities. A vital step in this direction is imparting the requisite knowledge and skill among healthcare providers. Medical education programs with their static curricula seldom adapt to the changing needs of neonatal healthcare providers in patient-centered, collaborative and remote delivery contexts. E-learning is emerging as the cutting edge tool towards refinement of knowledge, attitude and practices of physicians. Module-based e-learning courses can be blended with a skill learning contact period in partnering institutions thus saving resources and rapidly covering a wide geographical region with uniform standardized education. In this review, the authors discuss their experience with e-learning aimed at introducing and refining the understanding of sick newborn care among pre-service and in-service doctors who manage neonates.

Trial of daily vitamin D supplementation in preterm infants.

OBJECTIVE: To compare the effect of 800 vs 400 IU of daily oral vitamin D3 on the prevalence of vitamin D deficiency (VDD) at 40 weeks' postmenstrual age (PMA) in preterm infants of 28 to 34 weeks' gestation. METHODS: In this randomized double-blind trial, we allocated eligible infants to receive either 800 or 400 IU of vitamin D3 per day (n = 48 in both groups). Primary outcome was VDD (serum 25-hydroxyvitamin D levels <20 ng/mL) at 40 weeks' PMA. Secondary outcomes were VDD, bone mineral content, and bone mineral density at 3 months' corrected age (CA). RESULTS: Prevalence of VDD in the 800-IU group was significantly lower than in the 400-IU group at 40 weeks (38.1% vs. 66.7%; relative risk: 0.57; 95% confidence interval: 0.37-0.88) and at 3 months' CA (12.5% vs. 35%; relative risk: 0.36; 95% confidence interval: 0.14-0.90). One infant (2.4%) in the 800-IU group had vitamin D excess (100-150 ng/mL). Bone mineral content (mean ± SD: 79.6 ± 16.8 vs. 84.7 ± 20.7 g; P = .27) and bone mineral density (0.152 ± 0.019 vs. 0.158 ± 0.021 g/cm2; P = .26) were not different between the 2 groups. CONCLUSIONS: Daily supplementation with 800 IU of vitamin D reduces the prevalence of VDD at 40 weeks' PMA and at 3 months' CA in preterm infants without showing any improvement in bone mineralization. However, there is a possibility that this dose may occasionally result in vitamin D excess.

Phenobarbitone in Rh hemolytic disease of the newborn: a randomized double-blinded placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn. STUDY DESIGN: In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy. RESULTS: Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04). CONCLUSIONS: PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.

Poor zinc status in early infancy among both low and normal birth weight infants and their mothers in Delhi.

BACKGROUND: Low birth weight (LBW) infants are at high risk of zinc deficiency, but there is a paucity of data on their zinc status. OBJECTIVE: To evaluate zinc status of LBW (BW <2,500 g) and normal birth weight (NBW; BW ≥ 2,500 g) infants at birth and in early infancy. METHODS: A total of 339 infants (LBW, n = 220; NBW, n = 119) were enrolled, and venous blood samples of mother-infant dyad were taken within 48 h of birth. Infants' levels were repeated between 2 and 10 months of age. Serum zinc levels were estimated using an inductively coupled plasma mass spectrometer. Primary outcome was zinc deficiency, defined as serum zinc <65 µg/dl. RESULTS: Zinc results were available for 182 LBW and 103 NBW infants at birth and for 100 LBW and 66 NBW infants at follow-up with a median postnatal age of 14 and 15.5 weeks, respectively. Median zinc levels were low and comparable at birth as well as at follow-up, with zinc deficiency being present in 51.0% of LBW and 42.4% of NBW infants at birth and in 79.0% of LBW and 66.7% of NBW infants at follow-up. Zinc levels decreased significantly in both groups from birth to follow-up, irrespective of zinc multivitamin supplementation. Zinc levels of infants with BW <2,000 g at follow-up were significantly lower compared to infants with higher BW. CONCLUSION: Zinc status was poor in many infants at birth irrespective of BW. Zinc status worsened significantly during early infancy, with infants with BW <2,000 g having the lowest zinc levels.

Vitamin D status of low birth weight infants in Delhi: a comparative study.

OBJECTIVE: To evaluate vitamin D status of preterm and term low birthweight (LBW) and term normal birth weight (NBW; weight ≥ 2500 g) infants at birth and in early infancy. METHODS: We enrolled 220 LBW and 119 NBW infants along with their mothers. Blood samples of both infants and mothers were taken within 48 h of birth, and that of infants were repeated at 3 months. Serum levels of calcium, phosphate, alkaline phosphatase, 25 hydroxyvitamin D (25OHD) and parathormone (PTH) were estimated using standard tests. Our primary outcome was vitamin D deficiency (VDD; serum 25OHD <20 ng/ml in mothers and <15 ng/ml in infants). Other outcomes were raised PTH (>46 pg/ml), raised AlkP (>120 U/l in mothers and 420 U/l in infants), and clinical rickets. FINDINGS: VDD was present in 186 (87.3%) of LBW and 103 (88.6%) of NBW infants at birth, and in 77 (60.6%) of LBW and 55 (71.6%) of NBW infants at a median corrected age of 12 and 15 weeks, respectively. VDD was almost universal (93-97%) among mothers of both groups. Raised PTH was present in 138 (63.6%) of LBW and 48 (41.4%) of NBW infants at birth, and in 58 (45.7%) of LBW and 38 (49.3%) of NBW infants at follow-up. Clinical rickets was present in 17 (13.4%) of LBW and 4 (4.9%) of NBW infants at 12-14 weeks of corrected age. CONCLUSIONS: High prevalence of VDD in LBW as well as NBW infants with clinical rickets at an early age underlines the need to study the effect of various vitamin D supplementation regimens in these infants to identify the optimal dose.

Light-emitting diode phototherapy for unconjugated hyperbilirubinaemia in neonates.

BACKGROUND: Phototherapy is the mainstay of treatment of neonatal hyperbilirubinaemia. The commonly used light sources for providing phototherapy are special blue fluorescent tubes, compact fluorescent tubes and halogen spotlights. However, light emitting diodes (LEDs) as light sources with high luminous intensity, narrow wavelength band and higher delivered irradiance could make phototherapy more efficacious than the conventional phototherapy units. OBJECTIVES: To evaluate the effect of LED phototherapy as compared to conventional phototherapy in decreasing serum total bilirubin levels and duration of treatment in neonates with unconjugated hyperbilirubinaemia. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2010, Issue 1), MEDLINE (1966 to April 30, 2010) and EMBASE (1988 to July 8, 2009). Handsearches of the proceedings of annual meetings of The European Society for Paediatric Research and The Society for Pediatric Research were conducted through 2010. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials were eligible for inclusion if they enrolled neonates (term and preterm) with unconjugated hyperbilirubinaemia and compared LED phototherapy with other light sources (fluorescent  tubes, compact fluorescent tubes, halogen spotlight; method of administration: conventional or fibreoptic). DATA COLLECTION AND ANALYSIS: We used the standard methods of The Cochrane Collaboration and its Neonatal Review Group for data collection and analysis. MAIN RESULTS: Six randomised controlled trials met the inclusion criteria for this review. Four studies compared LED and halogen light sources. Two studies compared LED and compact fluorescent light sources. The duration of phototherapy (six studies, 630 neonates) was comparable in LED and non-LED phototherapy groups (mean difference (hours) -0.43, 95% CI -1.91 to 1.05). The rate of decline of serum total bilirubin (STB) (four studies, 511 neonates) was also similar in the two groups (mean difference (mg/dL/hour) 0.01, 95% CI -0.02 to 0.04). Treatment failure, defined as the need of additional phototherapy or exchange blood transfusion (1 study, 272 neonates), was comparable (RR 1.83, 95% CI 0.47 to 7.17). Side effects of phototherapy such as hypothermia (RR 6.41, 95% CI 0.33 to 122.97), hyperthermia (RR 0.61, 95% CI 0.18 to 2.11) and skin rash (RR 1.83, 95% CI 0.17 to 19.96) were rare and occurred with similar frequency in the two groups. AUTHORS' CONCLUSIONS: LED light source phototherapy is efficacious in bringing down levels of serum total bilirubin at rates that are similar to phototherapy with conventional (compact fluorescent lamp (CFL) or halogen) light sources. Further studies are warranted for evaluating efficacy of LED phototherapy in neonates with haemolytic jaundice or in the presence of severe hyperbilirubinaemia (STB ≥ 20 mg/dL).

Efficacy of zinc in reducing hyperbilirubinemia among at-risk neonates: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy of oral zinc salt on the incidence of hyperbilirubinemia and need for phototherapy between 25 and 168 h of age in term and late-preterm at-risk neonates cared at a tertiary care hospital in New Delhi, India. METHODS: In all neonates born at ≥35 wks' gestation, serum total bilirubin (STB) was assayed at 24 ± 6 h of age. At-risk neonates, neonates with STB levels ≥6 mg/dL, were given either 10 mg of zinc gluconate salt (n = 148) or placebo (n = 146) in twice daily doses till day seven of age. Jaundice was assessed clinically and STB was measured by spectrophotometry. Neonates were followed up until day seven of age. Primary outcome measure was incidence of hyperbilirubinemia (STB ≥ 15 mg/dl). Secondary outcome measures were mean STB level at 72 ± 12 h of age, proportion of infants requiring phototherapy, and duration there of. RESULTS: Risk factors for hyperbilirubinemia, including male gender, gestational age, birth-weight, incidence of birth trauma, ABO incompatibility, hyperbilirubinemia in previous sib, etc. were comparable in zinc and placebo groups. The incidence of hyperbilirubinemia was comparable in both the groups (17.9% vs 19.1% in zinc and placebo groups respectively; OR = 0.95, 95% CI: 0.50 to 1.67; P = 0.92). The requirement of phototherapy (14.5% and 12.0% in zinc and placebo groups respectively; OR = 1.24, 95% CI: 0.95 to 2.6; P = 0.54) was comparable in both the groups; however, duration of phototherapy was shorter in zinc group (duration in hours, 22.8 ± 19.4 vs 35.6 ± 16.1 in zinc and placebo group respectively; mean difference = -12.8, 95% CI: -24.73 to -0.92; P = 0.04). There was no difference in the mean STB levels at 72 ± 12 h of age between zinc and placebo groups (mean difference in mg/dL: 0.20, 95% CI: 1.0 to -0.64). No significant adverse effects related to oral zinc administration were noted. CONCLUSIONS: Twice daily administration of oral zinc in a dose of 10 mg/day does not reduce the incidence of hyperbilirubinemia in at-risk term and late-preterm neonates during first wk of age.

Evaluation of phototherapy devices used for neonatal hyperbilirubinemia.

OBJECTIVE: To compare phototherapy devices based on their physical and photo-biological characteristics viz spectral properties, maximum and mean irradiance, treatable percentage of body surface area, decay of irradiance over time and in vitro photoisomerisation of bilirubin. DESIGN: In vitro experimental study. SETTING: Ocular pharmacy laboratory at a tertiary care hospital. METHODLOGY: All the characteristics were measured at a fixed distance of 35 cm from one compact fluorescent lamp (CFL) and three light emitting diode (LED) phototherapy devices in a dark room with an irradiance of <0.1uW/cm2/nm. Estimation of products of in vitro photoisomerisation was done using liquid chromatography - tandem mass spectroscopy (LC-MS/MS). RESULTS: The emission spectral data were comparable between the phototherapy devices. The devices, however, differed in their maximum irradiance with the spot and indigenous LED units having the highest and lowest values, respectively (56.5 and 16.8uW/cm2/nm). The mean irradiance measured in 5x5cm grids falling within the silhouette of a term baby of the spot and improvised LED devices were low (26.8uW/cm2/nm and 11.5uW/cm2/nm, respectively) possibly due to unevenness in the irradiance of light falling within the silhouette. There was a significant difference in the amount of bilirubin left after exposure to light over a 2hour time period (% reduction of bilirubin) among the four devices (P=0.001); at 120 minutes after exposure, the amount of bilirubin left was lowest for the CFL (16%) and spot LED (17%) devices and highest for the indigenous LED unit (41%). CONCLUSIONS: The four phototherapy devices differed markedly in their physical and photobiological characteristics. Since the efficacy of a device is dependent not only on the maximum irradiance but also on the mean irradiance, rate of decay of irradiance, and treatable surface area of the foot print of light, each phototherapy device should have these parameters verified and confirmed before being launched for widespread use.