NCT01754688|CompletedResults
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Sponsor study identifier
observational
624
1 country
1
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2012
Actual (reported)December 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 21, 2012
Actual (reported)February 2015
Actual (reported)February 2015
Actual (reported)January 25, 2019
Actual (reported)Bilirubin Induced Neurologic Dysfunction II Score (BIND II)
The original BIND was developed in the USA to score infants with Acute Bilirubin Encephalopathy using a focused physical exam (primarily neurologic) and history to determine the degree of encephalopathy a infant with jaundice displayed. The BIND has been adapted for Low-Middle-Income Countries. The bilirubin-induced neurologic dysfunction (BIND) scoring algorithm was developed, assigning 0, 1, 2 or 3 points to each of the four sections to indicate none, mild, moderate, or severe abnormalities in an infant's mental status, muscle tone, cry, and eye/facial findings. Each of the four sections has a maximum score of 3, giving a total BIND score range of 0 to 12. Higher scores indicate worsening signs of acute neurotoxicity associated with excessive hyperbilirubinemia.
Birth to 14 days
Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND)
Birth to 14 days
Bilirubin Induced Neurologic Dysfunction II score
Neonates admitted to Massey Street Children's Hospital
Massey Street Children's Hospital
Lagos, Nigeria
Tina Slusher, MD
University of Minnesota
624 participants (actual enrollment reported by the registry).
First Submitted
June 21, 2012
First Posted
December 21, 2012
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)Last Updated
January 25, 2019
Results First Posted
January 25, 2019
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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