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NCT03513640 Clinical Trial

Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants

Respiratory Distress Syndrome in Premature Infant Clinical Trial

Official title:
Prospective Cohort for Finding Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03513640
Other study ID # 1705-073-853
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 13, 2018
Est. completion date December 31, 2024

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact Seung Han Shin, M.D.
Phone +82220727230
Email revival421@snu.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 34 Weeks
Eligibility Inclusion Criteria: - premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia Exclusion Criteria: - major congenital anomalies - infants with hypotension while using inotropics

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of citrulline level between the meconium obstruction group and the normal feeding advance group check the citrulline llevel from blood at birth within 6 hours after birth
Primary 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 within 10 days before delivery
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