Meconium Obstruction of PrematurityNCT02864446
Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction
An observational study of Meconium Obstruction of Prematurity, run by Seoul National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Meconium Obstruction of Prematurity
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 weeks
- All sexes
- No healthy volunteers
- 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)
Who may be able to join
- preterm infants weighing <1,250g
Who cannot join
- major congenital anomalies
- perinatal asphyxia (cord pH <7.0)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Meconium Obstruction of Prematurity
- Medical subject headings
- Meconium Ileus
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group
Measured: within 48 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startOct 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meconium Obstruction of PrematurityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ee-Kyung Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864446
- Sponsor's protocol ID
- 1208-071-422
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of Urine Intestinal Fatty Acid Binding Protein in the Management of Very Low Birth Weight Infants With Meconium Obstruction
- ClinicalTrials.gov ID
- NCT02864446
- Acronym / sponsor ID
- 1208-071-422
- Conditions
- Meconium Obstruction of Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (1 listed)
- preterm infants weighing <1,250g
Key exclusion criteria (2 listed)
- major congenital anomalies
- perinatal asphyxia (cord pH <7.0)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group
Time frame: within 48 hours after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Individual participant dataSharing planned: Yes
Related trials for Meconium Obstruction of Prematurity
Recruiting
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
Meconium Obstruction of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meconium Obstruction of Prematurity, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group (time frame: within 48 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.