NCT01805206

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

March 4, 2013

Last Update Submit

May 13, 2015

Conditions

PrematurityNecrotizing Enterocolitis

Keywords

PrematurityNecrotizing EnterocolitisBiomarkersIntestinal Fatty Acid Binding ProteinFeeding

Outcome Measures

Primary Outcomes (1)

  • Incidence of necrotizing enterocolitis

    90 days

Secondary Outcomes (1)

  • Time to caloric goal for enteral feedings

    90 days

Study Arms (1)

iFABP Monitored

EXPERIMENTAL

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 iFABPOther: Administration of enteral feedings

Interventions

Assessment of urinary iFABPOTHER
iFABP Monitored
Administration of enteral feedingsOTHER
iFABP Monitored

Eligibility Criteria

AgeUp to 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age less than 33 weeks
  • Admission to Loma Linda University Children's Hospital NICU within 48 hours of life

You may not qualify if:

  • Anuria
  • Congenital gastrointestinal anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

Related 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.

    PMID: 21238645BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Premature BirthEnterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Gerald Gollin, MD

    Loma Linda University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 6, 2013

Study Start

November 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

US(1)