Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction
The Clinical Utility of Urine Intestinal Fatty Acid Binding Protein in the Management of Very Low Birth Weight Infants With Meconium Obstruction
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2012
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedAugust 12, 2016
August 1, 2016
2.9 years
August 2, 2016
August 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group
within 48 hours after birth
Other Outcomes (5)
Comparison of i-FABP level between breast milk feeding and formular feeding in the normal feeding advance group
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
within 48 hours after birth
Comparision of i-FABP level between preterm infants with chorioamnionitis and without chorioamnionitis in the normal feeding advance group
within 48 hours after birth
- +2 more other outcomes
Eligibility Criteria
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)
You may qualify if:
- preterm infants weighing \<1,250g
You may not qualify if:
- major congenital anomalies
- perinatal asphyxia (cord pH \<7.0)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Biospecimen
urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 12, 2016
Study Start
October 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
August 12, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share