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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

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
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.


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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 : December 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Jaundice infants
Bilirubin Induced Neurologic Dysfunction II score



Primary Outcome Measures :
  1. Bilirubin Induced Neurologic Dysfunction II Score (BIND II) [ Time Frame: 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) [ Time Frame: 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.




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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neonates admitted to Massey Street Children's Hospital
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754688


Locations
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Nigeria
Massey Street Children's Hospital
Lagos, Nigeria
Sponsors and Collaborators
University of Minnesota
Investigators
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Study Chair: Tina Slusher, MD University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01754688     History of Changes
Other Study ID Numbers: 1109M04335
First Posted: December 21, 2012    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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:
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Brain Diseases
Kernicterus
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic
Erythroblastosis, Fetal
Hematologic Diseases
Infant, Newborn, Diseases
Metabolic Diseases
Immune System Diseases
Hyperbilirubinemia
Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs