Clinical trial NCT03880591: Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo
Official title: Baseline Assessment of Neonatal Hyperbilirubinaemia in a Cohort of New-borns in Kinshasa, Democratic Republic of Congo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Hyperbilirubinemia
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Kinshasa School of Public Health
First posted: 2019-03-19
Enrollment: 306
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 306 in-hospital consecutive live births

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.

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.

Eligibility 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:

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

Primary outcomes:
measure: Prevalence of neonatal hyperbilirubinaemia in a cohort of newborns
timeFrame: 72 hours
Secondary outcomes:
measure: Risk factors for neonatal hyperbilirubinaemia in the mother and the baby
timeFrame: At birth
Other outcomes:
Locations:
city: Kinsasa
country: Congo, The Democratic Republic of the
facility: Kinshasa Medical Oxford Research Unit
Study officials:
affiliation: University of Oxford
name: Caterina Fanello
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.