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NCT Number: NCT05639309

Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants.

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Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Circulation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Newborn Morbidity Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul St. Mary's Hospital

Seoul, Seocho-Gu, 06591, South Korea

About this study

The usefulness of cerebral and renal regional oxygen saturation (RSO2) values for assessing hemodynamically significant patent ductus arteriosus (hsPDA) has been described previously. Meanwhile, autoregulation of the splanchnic organs' perfusion is less developed compared to the cerebral and renal system, which makes the splanchnic bed more prone to perfusion decrease and ischemia in cases of volume depletion or poor circulation. If RSO2 is measure in the liver, the solid organ reflecting the splanchnic bed perfusion status, hsPDA may be more readily identified than when only cerebral and/or renal RSO2 is monitored.

This study aims to evaluate the usefulness of liver RSO2 measurement in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants, in comparison to cerebral and renal RSO2.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age at birth less than 32 weeks
  • Birthweight less than 1,500 grams

Exclusion criteria

  • Major congenital anomaly
  • chromosomal / genetic anomaly

Treatment and study plan

near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)

Device

regional oxygen saturation measurement

Primary outcomes

  1. Day 2 liver regional oxygen saturation

    Time frame: 48 to 72 hours of birth

    regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)

  2. Day 7 liver regional oxygen saturation

    Time frame: 7 (±2) days after birth

    regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)

  3. Day 14 liver regional oxygen saturation

    Time frame: 14 (±3) days after birth

    regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)

Secondary outcomes

  1. PDA liver regional oxygen saturation

    Time frame: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life

    regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)

Other outcomes

  1. Day 2 cerebral regional oxygen saturation

    Time frame: 48 to 72 hours of birth

    regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)

  2. Day 7 cerebral regional oxygen saturation

    Time frame: 7 (±2) days after birth

    regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)

  3. Day 14 cerebral regional oxygen saturation

    Time frame: 14 (±3) days after birth

    regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)

  4. PDA cerebral regional oxygen saturation

    Time frame: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life

    regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)

  5. Day 2 renal regional oxygen saturation

    Time frame: 48 to 72 hours of birth

    regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)

  6. Day 7 renal regional oxygen saturation

    Time frame: 7 (±2) days after birth

    regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)

  7. Day 14 renal regional oxygen saturation

    Time frame: 14 (±3) days after birth

    regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)

  8. PDA renal regional oxygen saturation

    Time frame: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life

    regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2022
Registry last updated
May 30, 2025

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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