Clinical trial NCT01754688: Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
Official title: Determining Prevalence of Acute Bilirubin Encephalopathy in Developing Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemic Encephalopathy
Keywords: Acute Bilirubin Encephalopathy
Bilirubin Induced Neurologic Dysfunction score
Hearing Test
Neonate
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 624
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates admitted to Massey Street Children's Hospital

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.

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.

Eligibility 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. -

Primary outcomes:
measure: Bilirubin Induced Neurologic Dysfunction II Score (BIND II)
timeFrame: Birth to 14 days
Secondary outcomes:
measure: Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND)
timeFrame: Birth to 14 days
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Massey Street Children's Hospital
Study officials:
affiliation: University of Minnesota
name: Tina Slusher, MD
role: STUDY_CHAIR
References: