Hypoxia, Brain, Premature Birth
Conditions
Keywords
Near-Infrared Spectroscopy
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.
Interventions
PROCEDUREUmbilical 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
PROCEDUREDelayed 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.
Sponsors
University of Ulm
University College Cork
University of Alberta
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sharp HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 28 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| StO2 - 10M | 1st 10 minutes of life | Cerebral Tissue Oxygen Saturation in the Delivery Room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| HR 24H | 1st 24 hours of life | Heart rate in the NICU |
| Blood Pressure NICU | 2st 24 hours of life | Mean Blood Pressure in the 1st 24 hours |
Countries
Canada, Germany, Ireland, United States
Outcome results
None listed