Clinical trial NCT02713464: Does Maternal Instruction Prevent Kernicterus in Nigeria?
Official title: Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kernicterus
Lead sponsor: Bilimetrix s.r.l.
Sponsor class: OTHER
Collaborators: name: Jos University Teaching Hospital
name: Bayern University Teaching Hospital
name: Ahmadu Bello University Teaching Hospital
name: Massey Street Children's Hospital
name: Federal Medical Center Asaba
name: University of Minnesota
First posted: 2016-03-18
Enrollment: 1765
Sex: ALL
Minimum age (years): 30
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* Newborn infant receiving treatment for neonatal jaundice

Exclusion Criteria:

* Non-viable premature infants
* Severe congenital defects.
* Postnatal age greater than 21 days

Primary outcomes:
measure: Acute bilirubin encephalopathy
timeFrame: at time of admission or discharge (1-21 days of life)
Secondary outcomes:
measure: Death from acute bilirubin encephalopathy or combined ABE/sepsis
timeFrame: 1-21 days of life
Other outcomes:
Locations:
Study officials:
affiliation: Jos University Teaching Hospital
name: Stephen Oguche, MBBS
role: STUDY_DIRECTOR
affiliation: Massey Street Pediatric Hospital, Lagos
name: Abieyuwa Emokpae, MBBS
role: STUDY_DIRECTOR
affiliation: Aminu Kano Teaching Hospital
name: Zubaida Farouk, MBBS
role: STUDY_DIRECTOR
affiliation: Federal Medical Center Asaba
name: Angela Okolo, MBBS
role: STUDY_DIRECTOR
affiliation: Ahmadu Bello University Teaching Hospital
name: Isa Abdulkadir, MBBS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.