Meconium Obstruction of PrematurityNCT03513640
Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants
An observational study of Meconium Obstruction of Prematurity and Respiratory Distress Syndrome in Premature Infant, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Although the pathophysiology of meconium obstruction of prematurity (MOP) is not clear, it is known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion during antenatal or perinatal period. Read more about this study
- Who is it for?
- Ages Up to 34 weeks
- Conditions the study is for
- Meconium Obstruction of Prematurity, Respiratory Distress Syndrome in Premature Infant
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Apr 2018to 31 Dec 2023
- 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 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature infants born less than 34 weeks who were admitted in neonatal intensive care unit at Seoul National University Children's Hospital
Who may be able to join
- premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia
Who cannot join
- major congenital anomalies
- infants with hypotension while using inotropics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort for Finding Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants
Although the pathophysiology of meconium obstruction of prematurity (MOP) is not clear, it is known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion during antenatal or perinatal period. Recently, the level of citrulline has been used as an index of function and injury of the small intestine State. This study aimed to evaluate citrulline level of cord blood as a marker for early detection and observe changes in intestinal blood flow in MOP patient.
And We aimed to confirm the efficacy of the AT/ET ratio (ratio of the pulmonary artery time-to-peak velocity interval to the right ventricular ejection time) of the prenatal pulmonary artery as a noninvasive predictor of neonatal respiratory distress syndrome.
- Medical subject headings
- Meconium Ileus
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of citrulline level between the meconium obstruction group and the normal feeding advance group
check the citrulline llevel from blood at birth
Measured: within 6 hours after birth
Comparison of prenatal AT/ET ratio of fetal pulmonary artery between respiratory distress syndrome group and the normal respiration group
Check the AT/ET ratio of fetal pulmonary artery within 10 days before birth
Measured: within 10 days before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start13 Apr 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- 48 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
- NCT03513640
- Sponsor's protocol ID
- 1705-073-853
- Status last verified
- May 2024
- First submitted
- 19 Apr 2018
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort for Finding Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants
- ClinicalTrials.gov ID
- NCT03513640
- Acronym / sponsor ID
- 1705-073-853
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 May 2018 (actual)
- 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.
Although the pathophysiology of meconium obstruction of prematurity (MOP) is not clear, it is known that the decrease of the intestinal peristalsis due to decreased intestinal perfusion during antenatal or perinatal period. Recently, the level of citrulline has been used as an index of function and injury of the small intestine State. This study aimed to evaluate citrulline level of cord blood as a marker for early detection and observe changes in intestinal blood flow in MOP patient.
And We aimed to confirm the efficacy of the AT/ET ratio (ratio of the pulmonary artery time-to-peak velocity interval to the right ventricular ejection time) of the prenatal pulmonary artery as a noninvasive predictor of neonatal respiratory distress syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature infants born less than 34 weeks who were admitted in neonatal intensive care unit at Seoul National University Children's Hospital
Key inclusion criteria (1 listed)
- premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia
Key exclusion criteria (2 listed)
- major congenital anomalies
- infants with hypotension while using inotropics
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 citrulline level between the meconium obstruction group and the normal feeding advance group
Time frame: within 6 hours after birth
check the citrulline llevel from blood at birth
Comparison of prenatal AT/ET ratio of fetal pulmonary artery between respiratory distress syndrome group and the normal respiration group
Time frame: within 10 days before delivery
Check the AT/ET ratio of fetal pulmonary artery within 10 days before 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 3 Jun 2024.
- Individual participant dataSharing planned: Yes
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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 and Respiratory Distress Syndrome in Premature Infant, 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 3 Jun 2024. 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 citrulline level between the meconium obstruction group and the normal feeding advance group (time frame: within 6 hours after birth). The study lists 2 primary outcomes in all. 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 3 Jun 2024.