Does Maternal Instruction Prevent Kernicterus in Nigeria?
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).
Full Title of Study: “Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: November 2015
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.
- 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.
Arms, Groups and Cohorts
- Active Comparator: maternal education
- Phase IIa: Pregnant women attending antenatal clinics or postpartum in clinics or hospital who receive programmed maternal education about risks and care of newborn jaundice.
- No Intervention: Historic control
- Phase I: (before-after design) Baseline prevalence of acute bilirubin encephalopathy before maternal education instituted.
- No Intervention: No intervention
- Phase IIb: Opportunistic controls – infants of mothers who failed to receive education about risks and care of newborn jaundice.
Clinical Trial Outcome Measures
- 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)
- 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
Participating in This Clinical Trial
- Newborn infant receiving treatment for neonatal jaundice Exclusion Criteria:
- Non-viable premature infants – Severe congenital defects. – Postnatal age greater than 21 days
Gender Eligibility: All
Minimum Age: 30 Minutes
Maximum Age: 21 Days
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Bilimetrix s.r.l.
- Jos University Teaching Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Richard Patridge Wennberg, Principal Investigator – Bilimetrix s.r.l.
- Overall Official(s)
- Stephen Oguche, MBBS, Study Director, Jos University Teaching Hospital
- Abieyuwa Emokpae, MBBS, Study Director, Massey Street Pediatric Hospital, Lagos
- Zubaida Farouk, MBBS, Study Director, Aminu Kano Teaching Hospital
- Angela Okolo, MBBS, Study Director, Federal Medical Center Asaba
- Isa Abdulkadir, MBBS, Study Director, Ahmadu Bello University Teaching Hospital
Citations Reporting on Results
Johnson L, Bhutani VK, Karp K, Sivieri EM, Shapiro SM. Clinical report from the pilot USA Kernicterus Registry (1992 to 2004). J Perinatol. 2009 Feb;29 Suppl 1:S25-45. doi: 10.1038/jp.2008.211.
Shapiro SM. Chronic bilirubin encephalopathy: diagnosis and outcome. Semin Fetal Neonatal Med. 2010 Jun;15(3):157-63. doi: 10.1016/j.siny.2009.12.004. Epub 2010 Jan 29.
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