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

Meconium Obstruction of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864446
• Other study ID #: 1208-071-422
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 10, 2016
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Weeks

Eligibility

Inclusion Criteria:

• preterm infants weighing <1,250g

Exclusion Criteria:

• major congenital anomalies

• perinatal asphyxia (cord pH <7.0)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Weight
• Cystic Fibrosis
• Intestinal Obstruction
• Meconium Obstruction of Prematurity

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Other	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	No
Other	Comparision of i-FABP level between preterm infants with chorioamnionitis and without chorioamnionitis in the normal feeding advance group		within 48 hours after birth	No
Other	Comparision of i-FABP level between preterm infants with maternal pregnancy induced hypertension (PIH) and without maternal PIH in the normal feeding advance group		within 48 hours after birth	No
Other	Comparison of i-FABP level between preterm infants with maternal premature rupture of membrane (PROM) and without PROM in the normal feeding advance group		within 48 hours after birth	No
Primary	Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group		within 48 hours after birth	No