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NCT03145142 Clinical Trial

PREMOD2 With Near Infrared Spectroscopy Sub-study

Premature Birth Clinical Trial

— PREMOD2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03145142
Other study ID # PREMOD2 - NIRS Sub-study
Secondary ID 1R01HD088646-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 6, 2017
Est. completion date December 15, 2024

Study information
Verified date December 2021
Source Sharp HealthCare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 121
Est. completion date December 15, 2024
Est. primary completion date September 17, 2018
Accepts healthy volunteers No
Gender All
Age group 23 Weeks to 28 Weeks
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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.

Locations
Country Name City State
Canada Governors of University of Alberta Edmonton Alberta
Germany University of ULM Ulm Baden-Wurttemberg
Ireland Cork University Maternity Hospital Cork
United States Sharp Mary Birch Hospital for Women and Newborns San Diego California

Sponsors (5)
Lead Sponsor Collaborator
Sharp HealthCare Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University College Cork, University of Alberta, University of Ulm

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary StO2 - 10M Cerebral Tissue Oxygen Saturation in the Delivery Room 1st 10 minutes of life
Secondary StO2 - 24H Cerebral Tissue Oxygen Saturation in the NICU 1st 24 hours of life
Secondary HR - 10M Heart Rate in the Delivery Room 1st 10 minutes of life
Secondary HR 24H Heart rate in the NICU 1st 24 hours of life
Secondary Blood Pressure NICU Mean Blood Pressure in the 1st 24 hours 2st 24 hours of life
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