Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03277768

Enrollment

Registered

2017-09-11

Start date

2015-05-01

Completion date

2018-08-23

Last updated

2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Patent Ductus Arteriosus, Premature Infant

Keywords

Premature infant, Tissue Oxygenation, Patent Ductus Arteriosus

Brief summary

The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at \< 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.

Interventions

DEVICEResonance Raman Spectroscopy (RRS)

Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Inclusion criteria

* Infants \< 30 weeks estimated gestational age

Exclusion criteria

* Infants with major congenital anomalies * Infants \>34 weeks post-menstrual age

Design outcomes

Primary

Measure	Time frame	Description
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.	Up to a maximum of 14 data collection times	Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.

Secondary

Measure	Time frame	Description
Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.	Up to a maximum of 14 data collection times	RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026