PREMOD2 With Near Infrared Spectroscopy Sub-study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoxia, Brain, Premature Birth

Intervention / Treatment
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* Procedure: Umbilical cord milking
* Procedure: Delayed Cord Clamping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Umbilical Cord Milking<br>Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds. | Procedure: Umbilical cord milking<br>* 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<br>|
| Active Comparator: Delayed Cord Clamping<br>Delayed clamping of the umbilical cord for at least 60 seconds. | Procedure: Delayed Cord Clamping<br>* At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| StO2 - 10M | Cerebral Tissue Oxygen Saturation in the Delivery Room | 1st 10 minutes of life | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-Infrared Spectroscopy