Trial Outcomes & Findings for Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries (NCT NCT01754688)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

624 participants

Primary outcome timeframe

Birth to 14 days

Results posted on

2019-01-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Neonates observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
Overall Study STARTED	624
Overall Study COMPLETED	624
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neonates n=624 Participants
Age, Continuous	39 weeks n=93 Participants
Sex/Gender, Customized Male	416 participant n=93 Participants
Sex/Gender, Customized Female	202 participant n=93 Participants
Sex/Gender, Customized Unknown	6 participant n=93 Participants
Admission Weight (kg)	3.0 kg n=93 Participants

PRIMARY outcome

Timeframe: Birth to 14 days

Population: observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE

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.

Outcome measures

Outcome measures
Measure	Neonates n=584 Participants observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
Bilirubin Induced Neurologic Dysfunction II Score (BIND II)	1 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Birth to 14 days

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.

Outcome measures

Outcome measures
Measure	Neonates n=624 Participants observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND)	3 units on a scale Interval 1.0 to 4.0

Adverse Events

Neonates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tina M. Slusher, MD

Minnesota Medical Research Foundation and University of Minnesota

Phone: 612-624-4586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place