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Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

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ClinicalTrials.gov Identifier: NCT01754688
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Hyperbilirubinemic Encephalopathy
Enrollment 624
Recruitment Details Recruitment was carried out at Massey Street Children's Hospital and the surrounding community in Lagos, Nigeria. Recruitment began in January 2013 and ended in March 2015.
Pre-assignment Details  
Arm/Group Title Neonates
Hide Arm/Group Description observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
Period Title: Overall Study
Started 624
Completed 624
Not Completed 0
Arm/Group Title Neonates
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 624
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 624 participants
39
(38 to 40)
[1]
Measure Description: Estimated Gestational Age (weeks)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 624 participants
Male 416
Female 202
Unknown 6
Admission Weight (kg)  
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 624 participants
3.0
(2.6 to 3.3)
1.Primary Outcome
Title Bilirubin Induced Neurologic Dysfunction II Score (BIND II)
Hide Description

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.

Time Frame Birth to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
Arm/Group Title Neonates
Hide Arm/Group Description:
observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
Overall Number of Participants Analyzed 584
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(0 to 4)
2.Secondary Outcome
Title Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND)
Hide Description

We will translate the BIND II into lay language and 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 compare the score of the community workers with those of the physicians to validate this score. The community workers will not examine the infants. They will do everything through questions and pictures and/or videos.

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.

Time Frame Birth to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neonates
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 624
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(1 to 4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neonates
Hide Arm/Group Description observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
All-Cause Mortality
Neonates
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neonates
Affected / at Risk (%)
Total   0/624 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neonates
Affected / at Risk (%)
Total   0/624 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Tina M. Slusher, MD
Organization: Minnesota Medical Research Foundation and University of Minnesota
Phone: 612-624-4586
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01754688     History of Changes
Other Study ID Numbers: 1109M04335
First Submitted: June 21, 2012
First Posted: December 21, 2012
Results First Submitted: July 27, 2016
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019