Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo

NCT03880591 | Completed

• 1 other identifier: NEHYA
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Risk factors for neonatal hyperbilirubinaemia in the mother and the baby

  At birth

Eligibility Criteria

• Age: Up to 60 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

306 in-hospital consecutive live births

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• Kinshasa School of Public Health: collaborator

Study Sites (1)

Kinshasa Medical Oxford Research Unit

Kinsasa, Democratic Republic of the Congo

Location

Related Publications (2)

• 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.

  PMID: 29637134 BACKGROUND

• Fanello C, Lee SJ, Bancone G, Kayembe D, Ndjowo P, Badjanga B, Gornsawun G, Chotthanawathit P, Waithira N, White NJ, Onyamboko M. Prevalence and Risk Factors of Neonatal Hyperbilirubinemia in a Semi-Rural Area of the Democratic Republic of Congo: A Cohort Study. Am J Trop Med Hyg. 2023 Sep 5;109(4):965-974. doi: 10.4269/ajtmh.23-0293. Print 2023 Oct 4.

  PMID: 37669757 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Neonatal Screening Cards (dried blood spots)

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Caterina Fanello

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 19, 2019
• Study Start: March 7, 2019
• Primary Completion: December 3, 2020
• Study Completion: December 10, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)