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NCT Number: NCT02864446

Intestinal Fatty Acid Binding Protein in 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.

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Key information

Conditions

Meconium Obstruction of Prematurity Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Meconium Ileus

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preterm infants weighing <1,250g

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group

    Time frame: within 48 hours after birth

Other outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2016
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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