Kernicterus
Conditions
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.
Interventions
BEHAVIORALmaternal 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.
Sponsors
Jos University Teaching Hospital
Bayern University Teaching Hospital
Ahmadu Bello University Teaching Hospital
Massey Street Children's Hospital
Federal Medical Center Asaba
University of Minnesota
Bilimetrix s.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Minutes to 21 Days
Healthy volunteers
No
Inclusion criteria
* Newborn infant receiving treatment for neonatal jaundice
Exclusion criteria
* Non-viable premature infants * Severe congenital defects. * Postnatal age greater than 21 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute bilirubin encephalopathy | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death from acute bilirubin encephalopathy or combined ABE/sepsis | 1-21 days of life | Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis |
Outcome results
None listed