PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
| Registry | NCT03145142, acronym PREMOD2 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 121 (Actual) |
| Sponsor | Sharp HealthCare (Other); collaborators: University of Ulm, University College Cork, University of Alberta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Conditions | Hypoxia, Brain, Premature Birth |
| Interventions | Umbilical cord milking, Delayed Cord Clamping (Procedure) |
| Dates | start 2017-06-06, primary completion 2018-09-17, completion 2024-12-15 (estimated), first posted 2017-05-09, last updated 2021-12-13 |
| Locations | 4 sites in United States, Canada, Germany, Ireland |
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All trials for Hypoxia, Brain All trials for Premature Birth All trials of Umbilical cord milking All trials of 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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Umbilical Cord Milking | Active comparator | Procedure: Umbilical cord milking | Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds. |
| Delayed Cord Clamping | Active comparator | Procedure: Delayed Cord Clamping | Delayed clamping of the umbilical cord for at least 60 seconds. |
Sex: All, ages: 23 Weeks to 28 Weeks
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
| Facility | City | Country | Status |
|---|---|---|---|
| Sharp Mary Birch Hospital for Women and Newborns | San Diego, California | United States | |
| Governors of University of Alberta | Edmonton, Alberta | Canada | |
| University of ULM | Ulm, Baden-Wurttemberg | Germany | |
| Cork University Maternity Hospital | Cork | Ireland |
NIH grants: R01HD088646