Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01754688
• Collaborator: (none)
• Enrollment: 624
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperbilirubinemic Encephalopathy

Detailed Description

This is a minimal risk observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE. Babies with suspected jaundice (n=709) and without jaundice (n=125) will be enrolled. Data from a hearing test, physical exam, and laboratory tests will be used to compare with the results from the scoring tool.

The BIND II will be done by the physician examining the infant before the ABR study is done as it is simply a scored physical exam focused on signs of acute bilirubin encephalopathy. The BIND II will be done by the physician examining the patient at/near the time of the ABR testing. The physician will be a consultant when possible but when not possible it will be another trained physician and that will be documented.

The BIND II will be done by the physician trained by a pediatric consultant or Drs. Slusher/Olunsanya. The ABR will be performed by audiology technicians under the direction of Dr. Olunsanya. Since Dr. Olunsanya will see some of the infants during this time and, therefore, not be blinded to their clinical status, Dr. Steve Shapiro, a pediatric neurologist with expertise in reading ABE in infants and children with ABE/Kernicterus, will read all ABR while remaining blinded to clinical details of each infant.

The mothers will then be interviewed by trained community workers during either a follow-up visit at the hospital or at a later time during the admission if the baby is still admitted. The mothers will be shown photographs, video, and will listen to audio recordings as part of the interview process. These images and recordings are used to ask questions about the mother's perception of her baby's condition at the time of the initial admission. The community workers will complete the Community- or C-BIND form and determine a rating. This rating will then be compared with the physicians' BIND II score. The community worker will be blinded to the results of the BIND II and the ABR reading.

Community health worker will be defined as a lay person not formally trained as a registered nurse or doctor but may have training as an assistant nurse although this will not be required. Lay workers qualified to be community health workers but not yet working as community health workers will be able to participate as community health workers in this study.

Study Design

• Study Type: Observational
• Actual Enrollment: 624 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Jaundice infants Bilirubin Induced Neurologic Dysfunction II score

Outcome Measures

Primary Outcome Measures

1. Bilirubin Induced Neurologic Dysfunction II Score (BIND II) [Birth to 14 days]

   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.

Secondary Outcome Measures

1. Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 14 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects will be eligible to participate in the study if all of the following conditions exist:

1. At time of birth, neonates who are ≥ 35 weeks gestational age or

≥ 2250 grams if gestational age unavailable.

1. ≤ 14 days old

2. Parent or guardian has given consent for the infant to participate

Exclusion Criteria:

1. Infants with a condition requiring urgent referral to another facility for treatment not available at the hospital study site.

2. Infants being admitted for a surgical procedure only without an underlying medical illness.

3. Infants who have a condition that requires no blood draws for treatment of their problem and only reason for blood draw would be study enrollment. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massey Street Children's Hospital	Lagos		Nigeria

Sponsors and Collaborators

• University of Minnesota

Investigators

• Study Chair: Tina Slusher, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01754688
• Other Study ID Numbers: 1109M04335
• First Posted: Dec 21, 2012
• Last Update Posted: Jan 25, 2019
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by University of Minnesota: Acute Bilirubin Encephalopathy; Bilirubin Induced Neurologic Dysfunction score; Hearing Test; Neonate
• Additional relevant MeSH terms: Brain Diseases; Kernicterus

Study Results

Participant Flow

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.

Arm/Group Title	Neonates
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

Baseline Characteristics

Arm/Group Title	Neonates
Arm/Group Description
Overall Participants	624
Age (weeks) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [weeks]	39
Sex/Gender, Customized (participant) [Number]
Male	416
Female	202
Unknown	6
Admission Weight (kg) (kg) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg]	3.0

Outcome Measures

1. Primary Outcome

Title	Bilirubin Induced Neurologic Dysfunction II Score (BIND II)
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Neonates
Arm/Group Description	observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE
Measure Participants	584
Median (Inter-Quartile Range) [units on a scale]	1

2. Secondary Outcome

Title	Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Neonates
Arm/Group Description
Measure Participants	624
Median (Inter-Quartile Range) [units on a scale]	3

Adverse Events

Arm/Group Title	Neonates
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Neonates
	Affected / at Risk (%)	# Events
Total	0/624 (0%)
Other (Not Including Serious) Adverse Events
	Neonates
	Affected / at Risk (%)	# Events
Total	0/624 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.