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: Completed

Administrative data

• NCT number: NCT03513640
• Other study ID #: 1705-073-853
• Status: Completed
• Start date: April 13, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 48
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Intestinal Obstruction
• Meconium Ileus
• Meconium Obstruction of Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn
• Syndrome

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