# INFANT HEME CATABOLISM AND CARBON MONOXIDE DETECTION

> **NIH NIH R01** · STANFORD UNIVERSITY · 1994 · $143,469

## Abstract

The effects of hyperbilirubinemia in premature infants, or in infants
with hemolytic disease, may be deleterious and different than in well,
term infants.  Therefore, it is important to distinguish between those
infants who are at low risk and those who are at high risk to develop
potentially dangerous jaundice due to increased bilirubin production or
to poor elimination.  In our first specific aim, we propose to examine
well, term neonates using noninvasive measurements of carbon monoxide in
breath (an index of bilirubin production) and of transcutaneous bilirubin
(an index of bilirubin accumulation).  The study design and statistical
methods for this aim have been reevaluated and explained in detail by a
professional statistician.  From these data, we will formulate criteria
to identify neonates who are either at low risk or at high risk for
developing potentially dangerous jaundice.  The application of the low
risk criteria to neonates will permit a pediatrician to reduce infant
hospitalization after birth.  In our second specific aim, we propose to
continue our assessment and characterization of selected metalloporphyrin
heme oxygenase (HO) inhibitors of bilirubin production, with respect to
their efficacy and safety in neonatal rat and nonhuman primate models of
increased bilirubin production.  Metalloporphyrins will be selected
according to the following criteria through an in-depth staged screening
program: i) potent heme oxygenase (HO) inhibition; ii) negligible
photoreactivity; iii) minimal catabolism; and iv) lack of short- and
long-term metabolic side effects.  A reduced, three-year budget is
proposed.  No funding is requested for our third specific aim which is
contingent upon FDA approval and our ability to identify the safest
effective metalloporphyrin, as well as an appropriate group of high risk
neonates selected from among those with severe hyperbilirubinemia due to
isoimmune hemolytic disease.  In this aim, we propose  to design and
conduct a double-blind, randomized, placebo-controlled clinical trial of
the selected HO inhibitor of bilirubin production, in neonates who are
at high risk for developing potentially dangerous jaundice, and who have
a greater than 80% probability of receiving an exchange transfusion.
Through the accomplishment of these goals, we believe we can facilitate,
for low risk neonates, an early discharge from the hospital and
outpatient management of transitional hyperbilirubinemia.  In addition,
through our laboratory studies and contingent clinical trial, we believe
that we can develop a safe and efficacious chemopreventive strategy for
high risk neonates as an alternative to risk-laden exchange transfusions.

## Key facts

- **NIH application ID:** 2197088
- **Project number:** 5R01HD014426-13
- **Recipient organization:** STANFORD UNIVERSITY
- **SAM.gov UEI:** HJD6G4D6TJY5
- **Principal Investigator:** DAVID K STEVENSON
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1994
- **Award amount:** $143,469
- **Award type:** 5
- **Project period:** 1987-01-01 → 1995-05-21

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/2197088

## Citation

> US National Institutes of Health, RePORTER application 2197088, INFANT HEME CATABOLISM AND CARBON MONOXIDE DETECTION (5R01HD014426-13). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/2197088. Licensed CC0.

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