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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880591
• Other study ID #: NEHYA
• Status: Completed
• Start date: March 7, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: April 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 10, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Minutes

Eligibility

Inclusion Criteria:

• All live male or female new-borns
• Mothers of any age, willing and able to give informed consent for participation in the survey and agree to stay 72 hours in hospital after giving birth

Exclusion Criteria:

• Newborn health conditions which makes difficult to drawn a blood sample
• Newborn health conditions requiring specific care not compatible with the survey procedures

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Kinshasa Medical Oxford Research Unit	Kinsasa

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Kinshasa School of Public Health

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

References & Publications (1)

Slusher TM, Zamora TG, Appiah D, Stanke JU, Strand MA, Lee BW, Richardson SB, Keating EM, Siddappa AM, Olusanya BO. Burden of severe neonatal jaundice: a systematic review and meta-analysis. BMJ Paediatr Open. 2017 Nov 25;1(1):e000105. doi: 10.1136/bmjpo-2017-000105. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of neonatal hyperbilirubinaemia in a cohort of newborns	Number of newborns with elevation of serum bilirubin to a level requiring treatment according to consensus-based bilirubin thresholds for gestational age within 72 hours from birth (https://www.nice.org.uk/guidance/cg98/resources)	72 hours
Secondary	Risk factors for neonatal hyperbilirubinaemia in the mother and the baby	Prevalence of Low Birth Weight (weight at birth), Prematurity (Estimated Gestational Age), Glucose-6-Phosphate Dehydrogenase deficiency and Sickle Cell Disease (both diagnosed by DNA analysis from Neonatal Screening Card), mother - child ABO and Rh factor blood incompatibility (Beth-Vincent and agglutination test), maternal malarial infection (microscopy) and sepsis (clinically diagnosed)	At birth