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Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01754688
First received: June 21, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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
Demonstrate BIND II Score of >=5, is Valid for Detecting Moderate to Severe ABE in Neonates <14 Days Old.
Demonstrate Community-BIND Instrument, a Modified BIND II, is a Valid and Reliable Tool for Detecting ABE.
Demonstrate That Community-BIND Can be Used for Acquiring Population-based Prevalence of ABE in the Community.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Validate the Bilirubin Induced Neurologic Dysfunction II score (BIND II) instrument or scoring tool in a Nigerian hospital [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The orginal BIND was developed in the USA to score infants with Acute Bilirubin Encephalopathy using a focused physical exam (primarily) neuroligic and history to determine the degree of encephalopathy a infant with jaundice displayed. The BIND has been adapted for Low-Middle-Income Countries. Our plan is to validate it by use a hearing test and physical exam and laboratory exams to rule out other causes of encephalopathy and rule in acute bilirubin encephalopathy


Secondary Outcome Measures:
  • Develop the community Bilirubin Induced Neurologic Dysfunction Score or BIND (C-BIND) score in lay language and validate it in a Nigerian hospital/clinic setting [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will translate the BIND II into lay language and they 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 who have had a hearing test and compare the score of the community workers with those of the physicians and the results of the hearing test and other labs to validate this score. The community workers will not exam the infants. They will do everything through questions and pictures and/or videos.

  • Conduct a pilot study to determine prevalence of Acute Bilirubin Encephalopathy (ABE) in a Nigerian community using C-BIND. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will take the C-BIND into the community around Massey Street Children's Hospital in year 2 of the study to determine the prevalence of ABE in that community after the C-BIND has been validated as above


Estimated Enrollment: 626
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Jaundice infants
Non-jaundiced infants

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754688

Contacts
Contact: Tina M Slusher, MD 612-840-8883 tslusher@umn.edu

Locations
Nigeria
Massey Street Children's Hospital Not yet recruiting
Lagos, Nigeria
Contact: Bolajoka O Olusanya, MBBS    011-234-803-334-4300    boolusanya@aol.com   
Principal Investigator: Bolajoko O Olusanya, MBBS         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Study Chair: Tina Slusher, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01754688     History of Changes
Other Study ID Numbers: 1109M04335
Study First Received: June 21, 2012
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kernicterus
Blood Group Incompatibility
Brain Diseases
Brain Diseases, Metabolic
Central Nervous System Diseases
Erythroblastosis, Fetal
Hematologic Diseases
Hyperbilirubinemia
Immune System Diseases
Infant, Newborn, Diseases
Metabolic Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014