Does Maternal Instruction Prevent Kernicterus in Nigeria?

Kernicterus Clinical Trial

Official title:

Effect of Education on Prevalence of Kernicterus in Five Regions in Nigeria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713464
• Other study ID #: SKIN1
• Status: Completed
• Phase: N/A
• First received: March 12, 2016
• Last updated: March 17, 2016
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Bilimetrix s.r.l.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nigeria: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1765
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kernicterus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Bilimetrix s.r.l.	Ahmad Bello University Teaching Hospital, Bayern University Teaching Hospital, Federal Medical Center Asaba, Jos University Teaching Hospital, Massey Street Childrens Hospital Lagos, University of Minnesota - Clinical and Translational Science Institute

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No