Does Maternal Instruction Prevent Kernicterus in Nigeria?
Primary Purpose
Kernicterus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
maternal education
Sponsored by
About this trial
This is an interventional prevention trial for Kernicterus
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
maternal education
Historic control
No intervention
Arm Description
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.
Phase I: (before-after design) Baseline prevalence of acute bilirubin encephalopathy before maternal education instituted.
Phase IIb: Opportunistic controls - infants of mothers who failed to receive education about risks and care of newborn jaundice.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Death from acute bilirubin encephalopathy or combined ABE/sepsis
Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis
Full Information
NCT ID
NCT02713464
First Posted
March 12, 2016
Last Updated
March 17, 2016
Sponsor
Bilimetrix s.r.l.
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT02713464
Brief Title
Does Maternal Instruction Prevent Kernicterus in Nigeria?
Official Title
Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bilimetrix s.r.l.
Collaborators
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kernicterus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1765 (Actual)
8. Arms, Groups, and Interventions
Arm Title
maternal education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Historic control
Arm Type
No Intervention
Arm Description
Phase I: (before-after design) Baseline prevalence of acute bilirubin encephalopathy before maternal education instituted.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Phase IIb: Opportunistic controls - infants of mothers who failed to receive education about risks and care of newborn jaundice.
Intervention Type
Behavioral
Intervention Name(s)
maternal education
Intervention Description
Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care.
Primary Outcome Measure Information:
Title
Acute bilirubin encephalopathy
Description
Clinical signs of bilirubin toxicity described by unique neurological features in the presence of hyperbilirubinemia: reported as yes, no, or suspect (mild signs)
Time Frame
at time of admission or discharge (1-21 days of life)
Secondary Outcome Measure Information:
Title
Death from acute bilirubin encephalopathy or combined ABE/sepsis
Description
Clinical signs of severe bilirubin toxicity with or without clinical signs of sepsis
Time Frame
1-21 days of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
21 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Oguche, MBBS
Organizational Affiliation
Jos University Teaching Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abieyuwa Emokpae, MBBS
Organizational Affiliation
Massey Street Pediatric Hospital, Lagos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zubaida Farouk, MBBS
Organizational Affiliation
Aminu Kano Teaching Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Angela Okolo, MBBS
Organizational Affiliation
Federal Medical Center Asaba
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isa Abdulkadir, MBBS
Organizational Affiliation
Ahmadu Bello University Teaching Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19177057
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.
Results Reference
result
PubMed Identifier
20116355
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.
Results Reference
result
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Does Maternal Instruction Prevent Kernicterus in Nigeria?
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