Prediction of NEC With Urinary iFABP

Status:Not yet recruiting
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Age Range:Any
Start Date:November 2014
End Date:July 2016
Contact:Gerald Gollin, MD

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An Assessment of Urinary Intestinal Fatty Acid Binding Protein as a Early Predictor of Necrotizing Enterocolitis

During the first four days of life, intestinal fatty acid binding protein (iFABP) is
elevated in the urine of premature babies who go on to develop necrotizing enterocolitis
(NEC) days to weeks later. This study aims to determine whether the withholding of feedings
in babies with an elevated urinary iFABP can reduce the incidence of NEC.

Necrotizing enterocolits (NEC) occurs with an incidence of 3-7% in very low birth weight
(<1500g) infants and is associated with significant morbidity and mortality. Earlier
detection of a subclinical prodrome in NEC might allow for the institution of measures that
could prevent or attenuate the severity of disease. We have demonstrated that levels of
urinary intestinal fatty acid binding protein (iFABPu), a sensitive and specific marker for
intestinal mucosal injury, were elevated in the first 4 days of life in all infants who
subsequently developed NEC. We hypothesize that, in the context of an elevated iFABPu in
the neonatal period, a significant proportion of NEC cases could be averted by not
initiating feedings.

The proposed study will be a three-year prospective trial of iFABPu monitoring during the
neonatal period in 220 infants of gestational age less than 33 weeks. Urine will be
collected in 12-hour aliquots over the first four days of life and the iFABPu will be
measured. On the afternoon of day of life four, infants in whom iFABPu exceeded 1000 pg/ml
at any time will be continued with no feedings, iFABPu will continue to be measured, and
trophic, breast milk feedings will only be initiated after iFABPu has normalized for five
days. Infants with non-elevated iFABPu over the first four days of life will have feedings
initiated on day of life four, in the absence of other contraindications. All subjects will
have urine collected daily over their entire hospital stay for iFABPu assay. However, after
the active study period (after feedings have been initiated) iFABPu findings will not be
communicated to the physicians caring for the subjects, but will be evaluated
retrospectively in order to better define the utility of iFABPu as a marker for impending
NEC later in newborn life.

If iFABPu monitoring is shown to be effective in reducing the incidence of NEC it would
revolutionize the care of premature infants by providing physicians with a tool that would
permit feeding decisions to be based directly upon the viability of the intestine, rather
than intuition.

Inclusion Criteria:

- Gestational age less than 33 weeks

- Admission to Loma Linda University Children's Hospital NICU within 48 hours of life

Exclusion Criteria:

- Anuria

- Congenital gastrointestinal anomaly
We found this trial at
Loma Linda, California 92354
Loma Linda, CA
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