NCT05639309

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 13, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

November 22, 2022

Last Update Submit

May 26, 2025

Conditions

Patent Ductus ArteriosusCirculationNewborn MorbidityPremature Birth

Outcome Measures

Primary Outcomes (3)

  • Day 2 liver regional oxygen saturation

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

    48 to 72 hours of birth

  • Day 7 liver regional oxygen saturation

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

    7 (±2) days after birth

  • Day 14 liver regional oxygen saturation

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

    14 (±3) days after birth

Secondary Outcomes (1)

  • PDA liver regional oxygen saturation

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

Other Outcomes (8)

  • Day 2 cerebral regional oxygen saturation

    48 to 72 hours of birth

  • Day 7 cerebral regional oxygen saturation

    7 (±2) days after birth

  • Day 14 cerebral regional oxygen saturation

    14 (±3) days after birth

  • +5 more other outcomes

Study Arms (2)

Case (hemodynamically significant patent ductus arteriosus)

Hemodynamically significant patent ductus arteriosus (hsPDA) diagnosed by echocardiographic criteria including pulsatile left-to-right shunt through patent ductus arteriosus, enlarged left atrium and/or left ventricle, increased left pulmonary artery velocity, absent or reversed end-diastolic flow of anterior cerebral artery and/or renal artery

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

Control (no hemodynamically significant patent ductus arteriosus)

no hsPDA based on the same echocardiographic criteria described for the Case group

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

Interventions

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

regional oxygen saturation measurement

Case (hemodynamically significant patent ductus arteriosus)Control (no hemodynamically significant patent ductus arteriosus)

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants born at less than 32 weeks' gestation and/or 1,500 grams at birth, who accepts informed consent from the their legal guardians (parents) will be included. Those with major congenital anomaly or genetic abnormality who are at high risk for adverse outcome and compensated circulatory status will be excluded.

You may qualify if:

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

You may not qualify if:

  • Major congenital anomaly
  • chromosomal / genetic anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seocho-Gu, 06591, South Korea

Location

MeSH Terms

Conditions

Ductus Arteriosus, PatentPremature Birth

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sook Kyung Yum, MD, PhD

    Seoul St. Mary's Hospital, Catholic Univeristy of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sook Kyung Yum

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 6, 2022

Study Start

January 13, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)