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

NCT03513640 | Completed DMC

• 1 other identifier: 1705-073-853
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Meconium Obstruction of Prematurity; Respiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• premature infants born less than 34 weeks from mother with pregnancy induced hypertension, pre-eclampsia or eclampsia

You may not qualify if:

• major congenital anomalies
• infants with hypotension while using inotropics

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample at birth for citrulline level analysis urine sample at the first day of life for fatty acid binding protein analysis

MeSH Terms

Conditions

Meconium Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: April 13, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)