Does Maternal Instruction Prevent Kernicterus in Nigeria?

Study Overview
=================
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.

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

Conditions
-----------------
Kernicterus

Intervention / Treatment
-----------------
* Behavioral: maternal education


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Minutes
Maximum Age: 21 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: maternal education<br>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. | Behavioral: maternal education<br>* Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care.<br>|
| No Intervention: Historic control<br>Phase I: (before-after design) Baseline prevalence of acute bilirubin encephalopathy before maternal education instituted. | |
| No Intervention: No intervention<br>Phase IIb: Opportunistic controls - infants of mothers who failed to receive education about risks and care of newborn jaundice. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute bilirubin encephalopathy | Clinical signs of bilirubin toxicity described by unique neurological features in the presence of hyperbilirubinemia: reported as yes, no, or suspect (mild signs) | at time of admission or discharge (1-21 days of life) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from acute bilirubin encephalopathy or combined ABE/sepsis | Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis | 1-21 days of life |