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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03513640
Collaborator
(none)
30
1
47.6
0.6

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Cohort for Finding Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants
Actual Study Start Date :
Apr 13, 2018
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 34 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ee-Kyung Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03513640
Other Study ID Numbers:
  • 1705-073-853
First Posted:
May 1, 2018
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021