Clinical Trial: Does Maternal Instruction Prevent Kernicterus in Nigeria?

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria

Brief 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 Summary: 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.
Sponsor: Bilimetrix s.r.l.

Current Primary Outcome: Acute bilirubin encephalopathy [ Time Frame: at time of admission or discharge (1-21 days of life) ]

Clinical signs of bilirubin toxicity described by unique neurological features in the presence of hyperbilirubinemia: reported as yes, no, or suspect (mild signs)


Original Primary Outcome: Same as current

Current Secondary Outcome: Death from acute bilirubin encephalopathy or combined ABE/sepsis [ Time Frame: 1-21 days of life ]

Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis


Original Secondary Outcome: Same as current

Information By: Bilimetrix s.r.l.

Dates:
Date Received: March 12, 2016
Date Started: January 2014
Date Completion:
Last Updated: March 17, 2016
Last Verified: March 2016