Does Maternal Instruction Prevent Kernicterus in Nigeria?

March 17, 2016 updated by: Richard Patridge Wennberg, Bilimetrix s.r.l.

Effect of Education on Prevalence of Kernicterus in Five Regions 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1765

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 minutes to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newborn infant receiving treatment for neonatal jaundice

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: 1-21 days of life
Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis
1-21 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bilimetrix s.r.l.

Collaborators

University of Minnesota
Ahmadu Bello University Teaching Hospital
Jos University Teaching Hospital
Bayern University Teaching Hospital
Massey Street Children's Hospital
Federal Medical Center Asaba

Investigators

  • Study Director: Stephen Oguche, MBBS, Jos University Teaching Hospital
  • Study Director: Abieyuwa Emokpae, MBBS, Massey Street Pediatric Hospital, Lagos
  • Study Director: Zubaida Farouk, MBBS, Aminu Kano Teaching Hospital
  • Study Director: Angela Okolo, MBBS, Federal Medical Center Asaba
  • Study Director: Isa Abdulkadir, MBBS, Ahmadu Bello University Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 12, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 18, 2016

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKIN1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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