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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02864446
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ee-Kyung Kim, Seoul National University Hospital

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.

Condition or disease
Meconium Obstruction of Prematurity

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Clinical Utility of Urine Intestinal Fatty Acid Binding Protein in the Management of Very Low Birth Weight Infants With Meconium Obstruction
Study Start Date : October 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight




Primary Outcome Measures :
  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 Outcome Measures:
  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 ]

Biospecimen Retention:   Samples Without DNA
urine


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

  • preterm infants weighing <1,250g

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864446


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Ee-Kyung Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02864446    
Other Study ID Numbers: 1208-071-422
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Meconium Ileus
Intestinal Obstruction
Cystic Fibrosis
Fetal Diseases
Birth Weight
Body Weight
Pregnancy Complications
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pancreatic Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases