Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
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.
Demonstrate BIND II Score of >=5, is Valid for Detecting Moderate to Severe ABE in Neonates <14 Days Old.
Demonstrate Community-BIND Instrument, a Modified BIND II, is a Valid and Reliable Tool for Detecting ABE.
Demonstrate That Community-BIND Can be Used for Acquiring Population-based Prevalence of ABE in the Community.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries|
- Validate the Bilirubin Induced Neurologic Dysfunction II score (BIND II) instrument or scoring tool in a Nigerian hospital [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754688
|Contact: Tina M Slusher, MDfirstname.lastname@example.org|
|Massey Street Children's Hospital||Not yet recruiting|
|Contact: Bolajoka O Olusanya, MBBS 011-234-803-334-4300 email@example.com|
|Principal Investigator: Bolajoko O Olusanya, MBBS|
|Study Chair:||Tina Slusher, MD||University of Minnesota - Clinical and Translational Science Institute|