Neonatal Hyperbilirubinemia Clinical Trial
Official title:
Baseline Assessment of Neonatal Hyperbilirubinaemia in a Cohort of New-borns in Kinshasa, Democratic Republic of Congo
NCT number | NCT03880591 |
Other study ID # | NEHYA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 7, 2019 |
Est. completion date | December 10, 2020 |
Verified date | April 2020 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Kinshasa Medical Oxford Research Unit | Kinsasa |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Kinshasa School of Public Health |
Congo, The Democratic Republic of the,
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
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 |
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