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Does Maternal Instruction Prevent Kernicterus in Nigeria?

Primary Purpose

Kernicterus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
maternal education
Sponsored by
Bilimetrix s.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kernicterus

Eligibility Criteria

30 Minutes - 21 Days (Child)All SexesDoes not accept healthy volunteers

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

    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
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    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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