PREMOD2 With Near Infrared Spectroscopy Sub-study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Women's Studies |
| Therapuetic Areas: | Neurology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/30/2018 |
| Start Date: | June 6, 2017 |
| End Date: | May 15, 2019 |
PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
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.
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.
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.
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.
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
We found this trial at
2
sites
San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4198
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