Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo

Neonatal Hyperbilirubinemia Clinical Trial

Official title: Baseline Assessment of Neonatal Hyperbilirubinaemia in a Cohort of New-borns in Kinshasa, Democratic Republic of Congo

Status Completed

Clinical Trial Summary

Neonatal hyperbilirubinaemia (NH) is common among healthy neonates and normally resolves within a week. Untreated pathological hyperbilirubinaemia, however, can result in long-term neurological sequelae, which compromise childhood development, or may result in perinatal death. True population-based data from middle to low-income countries are scarce and NH contribution to morbidity and mortality remains unclear. With this study the investigators aim at assessing the prevalence of neonatal hyperbilirubinaemia in a cohort of newborns in a maternity hospital in Kinshasa, the Democratic Republic of Congo, and at evaluating the possible risk factors for NH in the mother and the baby.

Clinical Trial Description

Neonatal hyperbilirubinaemia is common among healthy neonates and normally resolves within a week. Untreated pathological hyperbilirubinaemia, however, can result in long-term neurological sequelae, which compromise childhood development, or may result in perinatal death. Worldwide, this condition affects at least 481,000 term or near term newborn babies annually, causing 114,000 deaths and more than 63,000 cases of moderate or severe disability. In high-income settings, early diagnosis and treatment in neonatal intensive care units have dramatically improved the outcome for babies at risk. However, true population-based data from middle to low-income countries are scarce and NH contribution to morbidity and mortality remains unclear. The Democratic Republic of Congo is one of the 5 countries with the highest neonatal mortality rate: 29 per 1000 live births, with an estimated 96,963 annual deaths. NH diagnosis is mostly performed by visual inspection, which is not very reliable, and it is not systematically reported in maternity records. The primary objective is to evaluate the prevalence of neonatal hyperbilirubinaemia in a cohort of in-hospital consecutive live births. The secondary objective is to evaluate the possible risk factors for NH in the mother and the baby. The results of this survey will provide essential baseline data for the community. If the frequency of the NH and severe NH in the area is higher than routinely reported, prompt and appropriate management guidelines can be put in place to improve treatment to decrease neonatal mortality and neurological disabilities. ;

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

• NCT number: NCT03880591
• Study type: Observational
• Source: University of Oxford
• Status: Completed
• Start date: March 7, 2019
• Completion date: December 10, 2020