PREMOD2 With Near Infrared Spectroscopy Sub-study

Status unconfirmed · Not applicable

Conditions studied: Hypoxia, Brain, Premature Birth

In brief

Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns \<32 weeks, but did not show any differences in cerebral oxygenation.

Key facts

Study ID

NCT03145142

Run by

Sharp HealthCare

People needed

121

Starts

2017-06-06

Expected to finish

2024-12-15

Last updated by the study team

2021-12-13

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 23 weeks 0 days to 27 weeks 6 days.
• Enrolled in PREMOD2 trial.

You may not qualify if…

• NIRS Device not available
• Research Personnel not available

Where it is running

• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
• Governors of University of Alberta — Edmonton, Alberta, Canada
• University of ULM — Ulm, Baden-Wurttemberg, Germany
• Cork University Maternity Hospital — Cork, Ireland

Full record on ClinicalTrials.gov

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