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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 624

Contacts and Locations

Study Locations

• Nigeria
  • Lagos, Nigeria
    • Massey Street Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Neonates admitted to Massey Street Children's Hospital

Description

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.

  2. ≤ 14 days old
  3. 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. -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Jaundice infants; Bilirubin Induced Neurologic Dysfunction II score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND)	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.	Birth to 14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (ESTIMATE): December 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Neonate; Acute Bilirubin Encephalopathy; Bilirubin Induced Neurologic Dysfunction score; Hearing Test
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Hematologic Diseases; Infant, Newborn, Diseases; Brain Diseases, Metabolic; Hyperbilirubinemia; Erythroblastosis, Fetal; Brain Diseases; Kernicterus
• Other Study ID Numbers: 1109M04335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES