Intestinal Fatty Acid Binding Protein in Very Low Birth W... | NCT02864446

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

NCT02864446

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 12, 2016Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Meconium Obstruction of Prematurity

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 10, 2016

First Posted Date

Aug 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2016

Last Update Posted Date

Aug 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

preterm infants weighing <1,250g

Exclusion Criteria:

major congenital anomalies
perinatal asphyxia (cord pH <7.0)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

36 Weeks

Standard Ages

Child

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000074270	Meconium Ileus

Ancestor Terms

ID	Term
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided