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
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