Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction

August 10, 2016 updated by: Ee-Kyung Kim, Seoul National University Hospital

The Clinical Utility of Urine Intestinal Fatty Acid Binding Protein in the Management of Very Low Birth Weight Infants With Meconium Obstruction

Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in meconium obstruction of prematurity (MOP). This study aimed to evaluate urinary i-FABP in MOP patient as a marker for early detection.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants weighing <1,250g who were admitted in neonatal intensive care unit at Seoul National University Children's Hospital

  • Initial urine samples are collected at the time of 12, 24, 48 hours (+/- 6 hours) after birth.
  • Further urine samples are collected every 48 hours when the enteral feeding starts. (till the amount of feeding reaches to 40mL/kg/day)

Description

Inclusion Criteria:

  • preterm infants weighing <1,250g

Exclusion Criteria:

  • major congenital anomalies
  • perinatal asphyxia (cord pH <7.0)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group
Time Frame: within 48 hours after birth
within 48 hours after birth

Other Outcome Measures

Outcome Measure
Time Frame
Comparison of i-FABP level between breast milk feeding and formular feeding in the normal feeding advance group
Time Frame: through study completion (an average of 1 month)
through study completion (an average of 1 month)
Comparison of i-FABP level between preterm infants with small for gestational age and without small for gestational age in the normal feeding advance group
Time Frame: within 48 hours after birth
within 48 hours after birth
Comparision of i-FABP level between preterm infants with chorioamnionitis and without chorioamnionitis in the normal feeding advance group
Time Frame: within 48 hours after birth
within 48 hours after birth
Comparision of i-FABP level between preterm infants with maternal pregnancy induced hypertension (PIH) and without maternal PIH in the normal feeding advance group
Time Frame: within 48 hours after birth
within 48 hours after birth
Comparison of i-FABP level between preterm infants with maternal premature rupture of membrane (PROM) and without PROM in the normal feeding advance group
Time Frame: within 48 hours after birth
within 48 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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