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Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo

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ClinicalTrials.gov Identifier: NCT03880591
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Kinshasa School of Public Health
Information provided by (Responsible Party):
University of Oxford

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
Neonatal Hyperbilirubinemia

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.

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Study Type : Observational
Estimated 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 : March 7, 2019
Estimated Primary Completion Date : September 7, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice




Primary Outcome Measures :
  1. Prevalence of neonatal hyperbilirubinaemia in a cohort of newborns [ Time Frame: 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 [ Time Frame: 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)


Biospecimen Retention:   Samples With DNA
Neonatal Screening Cards (dried blood spots)


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
306 in-hospital consecutive live births
Criteria

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:

  • Health conditions of the newborn which makes in the judgement of the clinician difficult to drawn a blood sample or require specific care not compatible with the survey procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880591


Contacts
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Contact: Caterina Fanello, Ph.D. +447900278768 caterina.fanello@ndm.ox.ac.uk

Locations
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Congo, The Democratic Republic of the
Kinshasa Medical Oxford Research Unit Recruiting
Kinsasa, Congo, The Democratic Republic of the
Contact: Marie Onyamboko, D.Phil.    +243990024201    akatshimarie@yahoo.fr   
Sponsors and Collaborators
University of Oxford
Kinshasa School of Public Health
Investigators
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Principal Investigator: Caterina Fanello University of Oxford

Publications:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03880591     History of Changes
Other Study ID Numbers: NEHYA
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases