Hyperbilirubinemic Encephalopathy Clinical Trial
Official title:
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.
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.
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