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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03513640
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : March 31, 2020
Information provided by (Responsible Party):
Ee-Kyung Kim, 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.

Condition or disease
Meconium Obstruction of Prematurity Respiratory Distress Syndrome in Premature Infant

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Study Type : Observational
Estimated 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 : April 13, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Primary Outcome Measures :
  1. Comparison of citrulline level between the meconium obstruction group and the normal feeding advance group [ Time Frame: 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 [ Time Frame: within 10 days before delivery ]
    Check the AT/ET ratio of fetal pulmonary artery within 10 days before birth

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 34 Weeks   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03513640

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Contact: Seung Han Shin, M.D. +82220727230
Contact: Ee-Kyung Kim, PhD. +82220723628

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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Seung Han Shin, MD    82220727230   
Contact: Ee-Kyung Kim, PhD    82220723628   
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Ee-Kyung Kim, Professor, Seoul National University Hospital Identifier: NCT03513640    
Other Study ID Numbers: 1705-073-853
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meconium Ileus
Intestinal Obstruction
Cystic Fibrosis
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Fetal Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pregnancy Complications
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pancreatic Diseases
Genetic Diseases, Inborn