Clinical Trial: PREMOD2 - NIRS Sub-study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping

Brief Summary: 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.

Detailed Summary: This substudy will include 400 infants <28 weeks GA enrolled in the PREMOD2 trial. Once the newborn has been delivered, received the intervention (UCM or DCC), and been placed on the resuscitation bed a NIRS sensor and a pulse oximeter will be placed within 60 seconds. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the NICU. Heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.
Sponsor: Sharp HealthCare

Current Primary Outcome: StO2 - 10M [ Time Frame: 1st 10 minutes of life ]

Cerebral Tissue Oxygen Saturation in the Delivery Room


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • StO2 - 24H [ Time Frame: 1st 24 hours of life ]
    Cerebral Tissue Oxygen Saturation in the NICU
  • HR - 10M [ Time Frame: 1st 10 minutes of life ]
    Heart Rate in the Delivery Room
  • HR 24H [ Time Frame: 1st 24 hours of life ]
    Heart rate in the NICU
  • Blood Pressure NICU [ Time Frame: 2st 24 hours of life ]
    Mean Blood Pressure in the 1st 24 hours


Original Secondary Outcome: Same as current

Information By: Sharp HealthCare

Dates:
Date Received: May 4, 2017
Date Started: June 2017
Date Completion: January 2021
Last Updated: May 5, 2017
Last Verified: May 2017