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OpenTrials
Completed

NCT Number: NCT03513640

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.

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Key information

Conditions

Meconium Obstruction of Prematurity Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction Meconium Ileus Respiratory Distress Syndrome in Premature Infant

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Prospective Cohort for Finding Risk Factors of Meconium Obstruction and Respiratory Distress Syndrome in Preterm Infants

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 1, 2018
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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