- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02864446
Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction
August 10, 2016 updated by: Ee-Kyung Kim, Seoul National University Hospital
The Clinical Utility of Urine Intestinal Fatty Acid Binding Protein in the Management of 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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
Description
Inclusion Criteria:
- preterm infants weighing <1,250g
Exclusion Criteria:
- major congenital anomalies
- perinatal asphyxia (cord pH <7.0)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group
Time Frame: within 48 hours after birth
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within 48 hours after birth
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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through study completion (an average of 1 month)
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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
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within 48 hours after birth
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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
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within 48 hours after birth
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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
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within 48 hours after birth
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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
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within 48 hours after birth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
August 2, 2016
First Submitted That Met QC Criteria
August 10, 2016
First Posted (Estimate)
August 12, 2016
Study Record Updates
Last Update Posted (Estimate)
August 12, 2016
Last Update Submitted That Met QC Criteria
August 10, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Gastrointestinal Diseases
- Infant, Newborn, Diseases
- Body Weight
- Genetic Diseases, Inborn
- Intestinal Diseases
- Pregnancy Complications
- Pancreatic Diseases
- Birth Weight
- Cystic Fibrosis
- Intestinal Obstruction
- Meconium Ileus
- Fetal Diseases
Other Study ID Numbers
- 1208-071-422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Meconium Obstruction of Prematurity
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KK Women's and Children's HospitalSingapore General Hospital; Duke-NUS Graduate Medical School; Genome Institute... and other collaboratorsRecruitingMeconium Obstruction of PrematuritySingapore
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Seoul National University HospitalRecruitingRespiratory Distress Syndrome in Premature Infant | Meconium Obstruction of PrematurityKorea, Republic of
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Medical University of ViennaCompletedMeconium IleusAustria
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Nadja Haiden,MDCompletedMeconium Ileus | Very Low Birth Weight Infant
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Stanford UniversityMedtronic - MITGCompletedIntraventricular Hemorrhage of Prematurity | Complications of PrematurityUnited States
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University of Kansas Medical CenterCompletedComplication of PrematurityUnited States
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Zekai Tahir Burak Women's Health Research and Education...UnknownPrematurity of FetusTurkey
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Ludwig-Maximilians - University of MunichGerman Research Foundation; German Federal Ministry of Education and Research; Société des Produits Nestlé (SPN)CompletedPrematurity of FetusGermany
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Nantes University HospitalActive, not recruitingPrematurity of FetusFrance
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