NCT02713464

Does Maternal Instruction Prevent Kernicterus in Nigeria?

Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,765 (actual)
• Sponsor: Bilimetrix s.r.l. · Academic / Other
• Sex: All
• Age: 30 Minutes – 21 Days
• Healthy volunteers: Not accepted

Summary

This study examines (a) whether introduction of public, health provider, and maternal education about risks of jaundice will decrease the occurrence of ABE compared with baseline prevalence (before-after design) or (b) whether antenatal or postpartum instruction to mothers will decrease the incidence of ABE compared with those who did not received instruction (concurrent opportunistic controls in phase 2).

Detailed description

This 2 phase study first determines the prevalence of acute bilirubin encephalopathy (ABE) among newborns admitted for treatment of jaundice at 5 regional centers in Nigeria and identifies social/behavioral/medical factors associated with ABE. Information gained in phase 1 identified high risk sub-populations and guided selection of instructional materials for phase 2. Core data sheets submitted monthly by participating centers included clinical data, demographic information, number of antenatal clinic visits, birth place (hospital, clinic, home) and attendant, distance from care centers and reasons for delay, if any, in seeking care. Receipt of jaundice instruction by mothers is self-reported. Statistical analysis includes Chi square and logistic regression analysis of risk factors. Sample size: 1,000 subjects in each phase are required to demonstrate a 20% decrease in disease prevalence (baseline ABE incidence anticipated to be 15% of jaundiced babies) at 95% confidence level.

Conditions

• Kernicterus

Interventions

Type	Name	Description
BEHAVIORAL	maternal education	Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2016-03-18
• Last updated: 2016-03-18