Saving babies' lives (SBL) - a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial.

BACKGROUND: Neonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies' Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia. METHODS: This study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies' Lives programme, which is the intervention. The Saving Babies' Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies' Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation. DISCUSSION: Our study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04663620 . Registered on 11th December 2020, retrospectively registered.

Extreme neonatal hyperbilirubinaemia in refugee and migrant populations: retrospective cohort.

OBJECTIVE: To describe neonatal survival and long-term neurological outcome in neonatal hyperbilirubinaemia (NH) with extreme serum bilirubin (SBR) values. DESIGN: Retrospective chart review, a one-off neurodevelopmental evaluation. SETTING: Special care baby unit in a refugee camp and clinics for migrant populations at the Thailand-Myanmar border with phototherapy facilities but limited access to exchange transfusion (ET). PATIENTS: Neonates ≥28 weeks of gestational age with extreme SBR values and/or acute neurological symptoms, neurodevelopment evaluation conducted at 23-97 months of age. MAIN OUTCOME MEASURES: Neonatal mortality rate, prevalence of acute bilirubin encephalopathy (ABE) signs, prevalence of delayed development scores based on the Griffiths Mental Development Scale (GMDS). RESULTS: From 2009 to 2014, 1946 neonates were diagnosed with jaundice; 129 (6.6%) had extreme SBR values during NH (extreme NH). In this group, the median peak SBR was 430 (IQR 371-487) µmol/L and the prevalence of ABE was 28.2%. Extreme NH-related mortality was 10.9% (14/129). Median percentile GMDS general score of 37 survivors of extreme NH was poor: 11 (2-42). 'Performance', 'practical reasoning' and 'hearing and language' domains were most affected. Four (10.8%) extreme NH survivors had normal development scores (≥50th centile). Two (5.4%) developed the most severe form of kernicterus spectrum disorders. CONCLUSION: In this limited-resource setting, poor neonatal survival and neurodevelopmental outcomes, after extreme NH, were high. Early identification and adequate treatment of NH where ET is not readily available are key to minimising the risk of extreme SBR values or neurological symptoms.

Beliefs and practices during pregnancy, post-partum and in the first days of an infant's life in rural Cambodia.

BACKGROUND: The aim of this study was to record the beliefs, practices during pregnancy, post-partum and in the first few days of an infant's life, held by a cross section of the community in rural Cambodia to determine beneficial community interventions to improve early neonatal health. METHODS: Qualitative study design with data generated from semi structured interviews (SSI) and focus group discussions (FGD). Data were analysed by thematic content analysis, with an a priori coding structure developed using available relevant literature. Further reading of the transcripts permitted additional coding to be performed in vivo. This study was conducted in two locations, firstly the Angkor Hospital for Children and secondarily in five villages in Sotnikum, Siem Reap Province, Cambodia. RESULTS: A total of 20 participants underwent a SSIs (15 in hospital and five in the community) and six (three in hospital and three in the community; a total of 58 participants) FGDs were conducted. Harmful practices that occurred in the past (for example: discarding colostrum and putting mud on the umbilical stump) were not described as being practiced. Village elders did not enforce traditional views. Parents could describe signs of illness and felt responsible to seek care for their child even if other family members disagreed, however participants were unaware of the signs or danger of neonatal jaundice. Cost of transportation was the major barrier to healthcare that was identified. CONCLUSIONS: In the population examined, traditional practices in late pregnancy and the post-partum period were no longer commonly performed. However, jaundice, a potentially serious neonatal condition, was not recognised. Community neonatal interventions should be tailored to the populations existing practice and knowledge.

Neonatal Hyperbilirubinemia in a Marginalized Population on the Thai-Myanmar Border: a study protocol.

BACKGROUND: This study aims to identify risk factors and the neurodevelopmental impact of neonatal hyperbilirubinemia in a limited-resource setting among a refugee and migrant population residing along the Thai-Myanmar border, an area with a high prevalence of glucose-6-phosphate dehydrogenase-deficiency. METHODS: This is an analytic, observational, prospective birth cohort study including all infants of estimated gestational age equal to or greater than 28 weeks from mothers who followed antenatal care in the Shoklo Malaria Research Unit clinics. At birth, a series of clinical exams and laboratory investigations on cord blood will be carried out. Serum bilirubin will be measured in all infants during their first week of life. All the infants of the cohort will be clinically followed until the age of one year, including monitoring of their neurodevelopment. DISCUSSION: The strength of this study is the prospective cohort design. It will allow us to collect information about the pregnancy and detect all infants with neonatal hyperbilirubinemia, to observe their clinical response under treatment and to compare their neurodevelopment with infants who did not develop neonatal hyperbilirubinemia. Our study design has some limitations in particular the generalizability of our findings will be limited to infants born after the gestational age of 28 weeks onwards and neurodevelopment to the end of the first year of life. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02361788 , registration date September 1st, 2014.

Susceptibility of community-acquired pathogens to antibiotics in Africa and Asia in neonates--an alarmingly short review.

OBJECTIVE: To assess the susceptibility of community-acquired pathogens in neonatal sepsis to commonly prescribed antibiotics in sub-Saharan Africa and Asia since 2002. METHODS: Literature review in PubMed and Embase. Susceptibility was estimated for pathogens individually and stratified by region. Isolates were also classified into Gram positive and Gram negative pathogens to estimate their pooled susceptibility. RESULTS AND CONCLUSIONS: Only nine studies met the inclusion criteria. The available data indicated poor susceptibility to almost all commonly used antibiotics in pathogens such as Staphylococcus aureus and Klebsiella spp. Only Streptococcus pneumoniae exhibited good susceptibility to all drugs other than cotrimoxazole. The extreme scarcity of data prevents drawing any firm conclusions beyond the urgent need for more studies to identify the best treatments for neonatal sepsis in the developing world.