NCT03145142

PREMOD2 With Near Infrared Spectroscopy Sub-study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 23 Weeks – 28 Weeks
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Hypoxia, Brain
• Premature Birth

Interventions

Type	Name	Description
PROCEDURE	Umbilical cord milking	At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. The procedure infuses a placental transfusion of blood into the preterm infant and can be done in 15-20 seconds
PROCEDURE	Delayed Cord Clamping	At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.

Timeline

• Start date: 2017-06-06
• Primary completion: 2018-09-17
• Completion: 2024-12-15
• First posted: 2017-05-09
• Last updated: 2021-12-13

Locations

4 sites across 4 countries: United States, Canada, Germany, Ireland