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

Completed

• Conditions: Meconium Obstruction of Prematurity; Respiratory Distress Syndrome in Premature Infant

• Registration Number: NCT03513640
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-13
• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-30
• Study First Posted: 2018-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of citrulline level between the meconium obstruction group and the normal feeding advance group	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	within 10 days before delivery	Check the AT/ET ratio of fetal pulmonary artery within 10 days before birth

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of