Prediction of NEC With Urinary iFABP

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01805206
• Other study ID #: 215610
• Status: Withdrawn
• Phase: Phase 2
• First received: March 4, 2013
• Last updated: May 13, 2015
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: May 2015
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Premature Birth
• Prematurity

Intervention

Other:
• Assessment of urinary iFABP

• Administration of enteral feedings

Locations

Country	Name	City	State
United States	Loma Linda University Children's Hospital	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mannoia K, Boskovic DS, Slater L, Plank MS, Angeles DM, Gollin G. Necrotizing enterocolitis is associated with neonatal intestinal injury. J Pediatr Surg. 2011 Jan;46(1):81-5. doi: 10.1016/j.jpedsurg.2010.09.069. — View Citation

Stadie D, Boskovic DS, Plank MS, et al. Elevated urinary intestinal fatty acid binding protein precedes clinical indicators of necrotizing enterocolitis. JSR 179:319, 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of necrotizing enterocolitis		90 days	No
Secondary	Time to caloric goal for enteral feedings		90 days	No