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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Premature infants born less than 34 weeks who were admitted in neonatal intensive care unit at Seoul National University Children's Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Gastrointestinal Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Pregnancy Complications; Pancreatic Diseases; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Syndrome; Cystic Fibrosis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Intestinal Obstruction; Meconium Ileus; Fetal Diseases
• Other Study ID Numbers: 1705-073-853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No