Prediction of NEC With Urinary iFABP

• ClinicalTrials.gov Identifier: NCT01805206
• Recruitment Status: Withdrawn
• First Posted: March 6, 2013
• Last Update Posted: May 14, 2015
• Sponsor: Loma Linda University
• Information provided by (Responsible Party): Loma Linda University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Prematurity; Necrotizing Enterocolitis	Other: Assessment of urinary iFABP; Other: Administration of enteral feedings	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Incidence of necrotizing enterocolitis [ Time Frame: 90 days ]

Secondary Outcome Measures :

1. Time to caloric goal for enteral feedings [ Time Frame: 90 days ]

Eligibility Criteria

• Ages Eligible for Study: up to 2 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Loma Linda University Children's Hospital

Loma Linda, California, United States, 92354

Sponsors and Collaborators

Loma Linda University

Investigators

• Principal Investigator: Gerald Gollin, MD; Loma Linda University School of Medicine

More Information

Publications:

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.

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.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT01805206
• Other Study ID Numbers: 215610
• First Posted: March 6, 2013
• Last Update Posted: May 14, 2015
• Last Verified: May 2015

Keywords provided by Loma Linda University:

Prematurity; Necrotizing Enterocolitis; Biomarkers; Intestinal Fatty Acid Binding Protein; Feeding

Additional relevant MeSH terms:

Enterocolitis; Enterocolitis, Necrotizing; Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases