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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
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

June 21, 2012
December 21, 2012
November 13, 2015
December 2012
February 2015   (Final data collection date for primary outcome measure)
Validate the Bilirubin Induced Neurologic Dysfunction II score (BIND II) instrument or scoring tool in a Nigerian hospital [ Time Frame: 1 year ]
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
Same as current
Complete list of historical versions of study NCT01754688 on ClinicalTrials.gov Archive Site
  • 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 ]
    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 ]
    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
Same as current
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Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
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.
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Observational
Time Perspective: Prospective
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Probability Sample
Neonates admitted to Massey Street Children's Hospital
  • 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.
Other: Bilirubin Induced Neurologic Dysfunction II score
  • Jaundice infants
    Bilirubin Induced Neurologic Dysfunction II score
    Intervention: Other: Bilirubin Induced Neurologic Dysfunction II score
  • Non-jaundiced infants
    Bilirubin Induced Neurologic Dysfunction II score
    Intervention: Other: Bilirubin Induced Neurologic Dysfunction II score
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
677
626
February 2015
February 2015   (Final data collection date for primary outcome measure)

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. -
Sexes Eligible for Study: All
up to 14 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Nigeria
 
 
NCT01754688
1109M04335
No
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Study Chair: Tina Slusher, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
November 2015