N/A
N=624
Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
Hyperbilirubinemic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT01754688 ↗Enrolled (actual)
624
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Bilirubin Induced Neurologic Dysfunction II Score (BIND II) — 1 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bilirubin Induced Neurologic Dysfunction II Score (BIND II) |
1 | — |
| SECONDARY Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND) |
3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects will be eligible to participate in the study if all of the following conditions exist:
- At time of birth, neonates who are ≥ 35 weeks gestational age or
≥ 2250 grams if gestational age unavailable.
- ≤ 14 days old
- Parent or guardian has given consent for the infant to participate
Exclusion Criteria
- Infants with a condition requiring urgent referral to another facility for treatment not available at the hospital study site.
- Infants being admitted for a surgical procedure only without an underlying medical illness.
- 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. -
Data sourced from ClinicalTrials.gov (NCT01754688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.