PREMOD2 With Near Infrared Spectroscopy Sub-study

Not Applicable

Active, not recruiting

• Conditions: Hypoxia, Brain; Premature Birth
• Interventions: Procedure: Delayed Cord Clamping; Procedure: Umbilical cord milking

• Registration Number: NCT03145142
• Lead Sponsor: Sharp HealthCare

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 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.

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Study Start: 2017-06-06
• Primary Completion: 2018-09-17
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-13
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

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

Exclusion Criteria

• NIRS Device not available
• Research Personnel not available

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Cord Clamping	Delayed Cord Clamping	Delayed clamping of the umbilical cord for at least 60 seconds.
Umbilical Cord Milking	Umbilical cord milking	Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds.

Primary Outcome Measures

Name	Time	Method
StO2 - 10M	1st 10 minutes of life	Cerebral Tissue Oxygen Saturation in the Delivery Room

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Governors of University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Sharp Mary Birch Hospital for Women and Newborns; 🇺🇸 San Diego, California, United States

University of ULM; 🇩🇪 Ulm, Baden-Wurttemberg, Germany

Cork University Maternity Hospital; 🇮🇪 Cork, Ireland