Efficacy of antenatal corticosteroids on the lung development of premature children in Bangladesh - the BiLDing-ACTION cohort

Johns Hopkins University, Baltimore MD

Investigators

Abstract

PROJECT SUMMARY: BiLDing-ACTION aims to leverage two highly rigorous World Health Organization (WHO) randomized trials to establish a novel longitudinal cohort of prematurely born children in Bangladesh. The project will assess whether antenatal corticosteroids (ACS), versus placebo, improves lung growth and development among premature children born before 34 weeks (Aim 1) and between 34-36 weeks and 6 days (Aim 2) and whether ACS reduces the incidence of lower respiratory infections among prematurely born children in Bangladesh (Aim 3). In Bangladesh and other low- and middle-income countries (LMICs) preterm birth complications are the leading cause of mortality among children. Infants born prematurely are at risk of lung growth and functional deficits and chronic respiratory disease. The magnitude and pattern of lung function impairment and respiratory illness incidence among premature infants and preschool children in LMICs, and whether antenatal corticosteroids (ACS) have an impact on them, are unknown. In this project (Bangladesh infant Lung Development-ACS for Improving Outcomes in Preterm Newborns) we aim to utilize innovative infant and preschool-aged lung function testing and a novel FDA- approved digital stethoscope with automated lung sound analytics to evaluate ACS efficacy, compared to placebo, on lung development among premature children enrolled in the WHO ACTION Trials-I and III. Both studies are double-blinded, placebo-controlled trials of women and babies in Bangladesh. In Aim 1, we will determine whether ACS, versus placebo, improves lung growth and development between 6-8 years-of-age among children born <34 weeks' gestation in Bangladesh. In Aim 2 we will assess if ACS, compared to placebo, improves lung growth and development among late preterm infants in Bangladesh over the first three years of life. We hypothesize lung injury associated with prematurity is mitigated by ACS, and therefore lung function at six years of age (Aim 1a) and at 6 months of age (Aim 2a) and changing longitudinally between 6-8 years of age (Aim 1b) and 6 months to 3 years of age (Aim 2b), will be more favorable among ACS than placebo. Lastly, in Aim 3 we will evaluate whether ACS, compared to placebo, reduces the incidence of lower respiratory infections among school-aged children born <34 weeks gestation (Aim 3a) and severe lower respiratory infections among late preterm infants over the first three years of life (Aim 3b) in Bangladesh. We hypothesize that ACS, compared to placebo, will promote healthier lung development amongst prematurely born infants and children to reduce the incidence of lower respiratory infections. BiLDing-ACTION provides a unique opportunity to advance the healthcare of children born prematurely in low-resource settings, leveraging two prominent, singular WHO trials to strengthen the evidence-base for the early life lung health benefits of ACS for women at risk of premature delivery in LMICs.