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Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT03880591
Collaborator
Kinshasa School of Public Health (Other)
306
Enrollment
1
Location
21.2
Actual Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    306 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Baseline Assessment of Neonatal Hyperbilirubinaemia in a Cohort of New-borns in Kinshasa, Democratic Republic of Congo
    Actual Study Start Date :
    Mar 7, 2019
    Actual Primary Completion Date :
    Dec 3, 2020
    Actual Study Completion Date :
    Dec 10, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of neonatal hyperbilirubinaemia in a cohort of newborns [72 hours]

      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)

    Secondary Outcome Measures

    1. Risk factors for neonatal hyperbilirubinaemia in the mother and the baby [At birth]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 60 Minutes
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kinshasa Medical Oxford Research Unit Kinsasa Congo, The Democratic Republic of the

    Sponsors and Collaborators

    • University of Oxford
    • Kinshasa School of Public Health

    Investigators

    • Principal Investigator: Caterina Fanello, University of Oxford

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT03880591
    Other Study ID Numbers:
    • NEHYA
    First Posted:
    Mar 19, 2019
    Last Update Posted:
    Dec 14, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyperbilirubinemia, Neonatal
    Hyperbilirubinemia

    Study Results

    No Results Posted as of Dec 14, 2020