- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880591
Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo
December 11, 2020 updated by: University of Oxford
Baseline Assessment of Neonatal Hyperbilirubinaemia in a Cohort of New-borns in Kinshasa, Democratic Republic of Congo
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
306
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kinsasa, Congo, The Democratic Republic of the
- Kinshasa Medical Oxford Research Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 hour (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
306 in-hospital consecutive live births
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
At birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Caterina Fanello, University of Oxford
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2019
Primary Completion (Actual)
December 3, 2020
Study Completion (Actual)
December 10, 2020
Study Registration Dates
First Submitted
March 12, 2019
First Submitted That Met QC Criteria
March 18, 2019
First Posted (Actual)
March 19, 2019
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEHYA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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