Prediction of NEC With Urinary iFABP
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|ClinicalTrials.gov Identifier: NCT01805206|
Recruitment Status : Withdrawn (PI left institution prior to receiving funding)
First Posted : March 6, 2013
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prematurity Necrotizing Enterocolitis||Other: Assessment of urinary iFABP Other: Administration of enteral feedings||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Assessment of Urinary Intestinal Fatty Acid Binding Protein as a Early Predictor of Necrotizing Enterocolitis|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: iFABP Monitored
Subjects monitored for urinary iFABP content during the first 4-12 days of life. Enteral feedings administered when iFABP levels are normal during the first four days of life or, if elevated during the first four days of life, have normalized for five days.
Other: Assessment of urinary iFABP
Other: Administration of enteral feedings
- Incidence of necrotizing enterocolitis [ Time Frame: 90 days ]
- Time to caloric goal for enteral feedings [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805206
|United States, California|
|Loma Linda University Children's Hospital|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Gerald Gollin, MD||Loma Linda University School of Medicine|