Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight.

BACKGROUND: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain. METHODS: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life. RESULTS: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care. CONCLUSIONS: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).

Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

BACKGROUND: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. METHODS: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale. RESULTS: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).

Quality improvement initiative to improve the duration of kangaroo mother care for twin preterm neonates born at a tertiary care hospital in resource-limited settings.

AIM: Kangaroo mother care (KMC) can be challenging in multiple births and more so in resource-limited settings. This study aims at increasing the mean duration of KMC with early initiation in twin preterm neonates born at a tertiary care hospital using a quality improvement (QI) initiative. METHODS: Barriers for poor KMC practice in twin preterm neonates born at the tertiary care hospital were analysed and baseline data were collected over a period of 4 months using a predesigned proforma. A QI team was formed and suggested solutions were prioritised through focus group discussions in the form of Plan-Do-Study-Act (P-D-S-A) cycles. Each cycle was of one-month duration and three cycles were implemented, followed by the sustenance phase studied at 1-month post-implementation. RESULTS: There were a total of 238 twin deliveries in the study period, of which 169 twin pairs were included in the study. At the end of implementation, the average day of initiation of KMC improved from 8th to 3rd day of life and the duration of KMC increased significantly from an average of 2.70 h/infant/day to 7.88 h/infant/day. CONCLUSION: This QI project focused on the improvement of KMC practice in twin preterm neonates in a tertiary care hospital where results were achieved with maximal utilisation of available hospital resources and low-cost interventions. This study design is generalizable to other hospitals in resource-limited settings where family participatory care can be strengthened to overcome the challenges of KMC in multiple births.

Breast Milk Quality Improvement Bundle for Very Low Birth Weight Neonates.

PURPOSE: To assess the effect of a quality improvement (QI) bundle on improving breast milk output among very low birth weight (VLBW) mothers. DESIGN: Before and after nonrandomized QI project. SAMPLE: Mothers who delivered a VLBW infant in October and November 2015 were the prospective cohort. Those who delivered a VLBW infant in August and September 2015 were the retrospective cohort. The QI bundle consisted of early expression of milk, use of breast pumps, frequent expressions, videos, and regular counseling. This bundle was done for the prospective cohort. OUTCOMES MEASURES: Quantity of expressed breast milk on day 7. RESULTS: There were 13 mothers in the retrospective cohort and 18 mothers in the prospective one. The mean birth weight (1297.80 and 1207.70 g, p = .19) and gestation (32.5 and 31.5 wk, p = .27) were similar. There was a significant increase in the milk output on day 7 in the prospective group 113.6 ± 45 vs 182 ± 63 mL (p = .001).

Analgesic Efficacy of Oral Dextrose and Breast Milk during Nasopharyngeal Suctioning of Preterm Infants on CPAP: A Blinded Randomized Controlled Trial.

Continuous positive airway pressure (CPAP) requires nasopharyngeal suctioning for airway patency, which is painful. Other procedures have used breast milk and 25% dextrose as analgesics. We aimed to compare their analgesic efficacy during nasopharyngeal suctioning in preterm neonates on CPAP. In this blinded randomized controlled trial, babies received 25% dextrose or breast milk orally. Pain before, during and after was assessed using the Premature Infant Pain Profile (PIPP) score. Analysis was done for 40 babies. The mean PIPP score in the 25% dextrose group during the procedure was 11.25 ± 2.73 and 13.2 ± 2.55 (p = 0.02) with the intervention and without. In the breast milk group the PIPP score during the procedure was 11.35 ± 3.05 and 13.45 ± 3.27 (p = 0.04); this difference persisted even after the procedure. There was no significant difference between the interventions. Both interventions significantly reduce pain. The analgesic effect of breast milk was sustained.

Efficacy of expressed breast milk in reducing pain during ROP screening--a randomized controlled trial.

OBJECTIVE: To assess the effectiveness of expressed breast milk (EBM) on neonatal pain during screening for retinopathy of prematurity (ROP). METHODS: Neonates who were on oral feeds undergoing ROP screening were included. Babies were randomized into intervention group (EBM + Standard practice) and control group. The standard practice is proparacaine, nesting and swaddling. Pain was assessed by PIPP scale, during and at 1 and 5 min after the procedure by the principal investigator who was blinded. RESULTS: The groups were similar in baseline characteristics. The group receiving EBM had significantly lower PIPP scores during the procedure 12.7 ± 1.69 compared to the control group 15.5 ± 1.78 (p < 0.05). The beneficial effect persisted at 1 min and 5 min after the procedure 6.20 ± 1.9 vs. 12.4 ± 2.54 (p ≤ 0.05) at 1 min; 3.2 ± 1.5 and 6.85 ± 2.4 (p < 0.05) at 5 min. CONCLUSION: Oral EBM significantly reduces pain during and after ROP screening.

Decreasing antibiotic over-use by implementation of an antibiotic stewardship programme in preterm neonates in resource limited settings - a quality improvement initiative.

BACKGROUND: Antibiotics play a critical role in neonatal sepsis but excessive use is associated with adverse outcomes and the current prescribing rates of antibiotics are unacceptably high. AIM: To reduce antibiotic over-use in preterm neonates by implementing an antibiotic stewardship programme using a quality improvement (QI) initiative. METHODS: This study was conducted at a neonatal intensive care unit in a resource-limited setting. The reasons for antibiotic over-use were analysed and an antibiotic stewardship programme was implemented by using a QI initiative. The duration of the QI was a 1-month baseline phase followed by 3 months of implementation which was undertaken in the form of Plan-Do-Study-Act (P-D-S-A) cycles. The sustainment phase was observed for 2 months. All neonates admitted to the preterm unit were included. The outcome measure was the antibiotic usage expressed as days of therapy (DOT)/1000 patient days. RESULTS: In the baseline phase, DOT/1000 patient days was 1464 which fell to 706, 511, and 442 DOT/1000 patient days, respectively, over 3 months, resulting in a 65% reduction in antibiotic usage. This was achieved by a combination of efforts directed towards defining the conditions for no antibiotics, revising existing antibiotic policy, stopping orders at 48 hours, de-escalation to the narrowest spectrum antibiotic, stopping prophylactic antifungal agents and limited use of broad-spectrum antibiotics. The results were achieved without an increase in culture-positive sepsis or mortality. CONCLUSIONS: Implementation of a tailored antibiotic stewardship programme through a QI initiative was effective and safe in reducing antibiotic use in preterm neonates in a resource-limited setting. ABBREVIATIONS: AIIMS, All India Institute of Medical Sciences; DOT, days of therapy; HIC, high-income countries; ICMR, Indian Council of Medical Research; LMIC, low- to middle-income countries; LOS, late-onset sepsis; NICU, neonatal intensive care unit; NNF, National Neonatology Forum; P-D-S-A, plan-do-study-act; QI, quality improvement; SNCU, Special newborn care unit.

Preterm care during the COVID-19 pandemic: A comparative risk analysis of neonatal deaths averted by kangaroo mother care versus mortality due to SARS-CoV-2 infection.

BACKGROUND: COVID-19 is disrupting health services for mothers and newborns, particularly in low- and middle-income countries (LMIC). Preterm newborns are particularly vulnerable. We undertook analyses of the benefits of kangaroo mother care (KMC) on survival among neonates weighing ≤2000 g compared with the risk of SARS-CoV-2 acquired from infected mothers/caregivers. METHODS: We modelled two scenarios over 12 months. Scenario 1 compared the survival benefits of KMC with universal coverage (99%) and mortality risk due to COVID-19. Scenario 2 estimated incremental deaths from reduced coverage and complete disruption of KMC. Projections were based on the most recent data for 127 LMICs (~90% of global births), with results aggregated into five regions. FINDINGS: Our worst-case scenario (100% transmission) could result in 1,950 neonatal deaths from COVID-19. Conversely, 125,680 neonatal lives could be saved with universal KMC coverage. Hence, the benefit of KMC is 65-fold higher than the mortality risk of COVID-19. If recent evidence of 10% transmission was applied, the ratio would be 630-fold. We estimated a 50% reduction in KMC coverage could result in 12,570 incremental deaths and full disruption could result in 25,140 incremental deaths, representing a 2·3-4·6% increase in neonatal mortality across the 127 countries. INTERPRETATION: The survival benefit of KMC far outweighs the small risk of death due to COVID-19. Preterm newborns are at risk, especially in LMICs where the consequences of disruptions are substantial. Policymakers and healthcare professionals need to protect services and ensure clearer messaging to keep mothers and newborns together, even if the mother is SARS-CoV-2-positive. FUNDING: Eunice Kennedy Shriver National Institute of Child Health & Human Development; Bill & Melinda Gates Foundation; Elma Philanthropies; Wellcome Trust; and Joint Global Health Trials scheme of Department of Health and Social Care, Department for International Development, Medical Research Council, and Wellcome Trust.

Small and sick newborn care during the COVID-19 pandemic: global survey and thematic analysis of healthcare providers' voices and experiences.

INTRODUCTION: The COVID-19 pandemic is disrupting health systems globally. Maternity care disruptions have been surveyed, but not those related to vulnerable small newborns. We aimed to survey reported disruptions to small and sick newborn care worldwide and undertake thematic analysis of healthcare providers' experiences and proposed mitigation strategies. METHODS: Using a widely disseminated online survey in three languages, we reached out to neonatal healthcare providers. We collected data on COVID-19 preparedness, effects on health personnel and on newborn care services, including kangaroo mother care (KMC), as well as disruptors and solutions. RESULTS: We analysed 1120 responses from 62 countries, mainly low and middle-income countries (LMICs). Preparedness for COVID-19 was suboptimal in terms of guidelines and availability of personal protective equipment. One-third reported routine testing of all pregnant women, but 13% had no testing capacity at all. More than 85% of health personnel feared for their own health and 89% had increased stress. Newborn care practices were disrupted both due to reduced care-seeking and a compromised workforce. More than half reported that evidence-based interventions such as KMC were discontinued or discouraged. Separation of the mother-baby dyad was reported for both COVID-positive mothers (50%) and those with unknown status (16%). Follow-up care was disrupted primarily due to families' fear of visiting hospitals (~73%). CONCLUSION: Newborn care providers are stressed and there is lack clarity and guidelines regarding care of small newborns during the pandemic. There is an urgent need to protect life-saving interventions, such as KMC, threatened by the pandemic, and to be ready to recover and build back better.