Clinical Trial: Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

Brief Summary: The investigators hypothesize that a new BIND (Bilirubin Induced Neurologic Dysfunction) scoring method adapted for the developing world (BIND II, developed by our team for use by health care workers), with additional modifications for community use (the community BIND, C-BIND), will improve the ability to identify infants with ABE and to distinguish ABE from other common causes of neonatal morbidity and mortality compared to currently available survey tools.

Detailed Summary:
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Validate the Bilirubin Induced Neurologic Dysfunction II score (BIND II) instrument or scoring tool in a Nigerian hospital [ Time Frame: 1 year ]

The orginal BIND was developed in the USA to score infants with Acute Bilirubin Encephalopathy using a focused physical exam (primarily) neuroligic and history to determine the degree of encephalopathy a infant with jaundice displayed. The BIND has been adapted for Low-Middle-Income Countries. Our plan is to validate it by use a hearing test and physical exam and laboratory exams to rule out other causes of encephalopathy and rule in acute bilirubin encephalopathy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Develop the community Bilirubin Induced Neurologic Dysfunction Score or BIND (C-BIND) score in lay language and validate it in a Nigerian hospital/clinic setting [ Time Frame: 1 year ]
    We will translate the BIND II into lay language and they have community workers administer it using pictures and/or short videos along with simple questions to the same infants that the doctors performed the BIND II and who have had a hearing test and compare the score of the community workers with those of the physicians and the results of the hearing test and other labs to validate this score. The community workers will not exam the infants. They will do everything through questions and pictures and/or videos.
  • Conduct a pilot study to determine prevalence of Acute Bilirubin Encephalopathy (ABE) in a Nigerian community using C-BIND. [ Time Frame: 1 year ]
    We will take the C-BIND into the community around Massey Street Children's Hospital in year 2 of the study to determine the prevalence of ABE in that community after the C-BIND has been validated as above


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: June 21, 2012
Date Started: December 2012
Date Completion:
Last Updated: November 11, 2015
Last Verified: November 2015