Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of NEC With Urinary iFABP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (PI left institution prior to receiving funding)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
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Layout table for investigator information
Principal Investigator: Gerald Gollin, MD Loma Linda University School of Medicine
Publications:
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.

Layout table for additonal information
Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01805206    
Other Study ID Numbers: 215610
First Posted: March 6, 2013    Key Record Dates
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:
Layout table for MeSH terms
Enterocolitis
Enterocolitis, Necrotizing
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases