We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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
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

Study Type : Observational
Actual Enrollment : 677 participants
Time Perspective: Prospective
Official Title: Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
Study Start Date : December 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Jaundice infants
Bilirubin Induced Neurologic Dysfunction II score
Other: Bilirubin Induced Neurologic Dysfunction II score
Non-jaundiced infants
Bilirubin Induced Neurologic Dysfunction II score
Other: Bilirubin Induced Neurologic Dysfunction II score



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Nigeria
Massey Street Children's Hospital
Lagos, Nigeria
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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01754688     History of Changes
Other Study ID Numbers: 1109M04335
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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