Clinical trial NCT03145142: PREMOD2 With Near Infrared Spectroscopy Sub-study
Official title: PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia, Brain
Premature Birth
Keywords: Near-Infrared Spectroscopy
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: University of Ulm
name: University College Cork
name: University of Alberta
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-09
Enrollment: 121
Sex: ALL
Minimum age (years): 23
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: StO2 - 10M
timeFrame: 1st 10 minutes of life
Secondary outcomes:
measure: StO2 - 24H
timeFrame: 1st 24 hours of life
measure: HR - 10M
timeFrame: 1st 10 minutes of life
measure: HR 24H
timeFrame: 1st 24 hours of life
measure: Blood Pressure NICU
timeFrame: 2st 24 hours of life
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Edmonton
country: Canada
facility: Governors of University of Alberta
state: Alberta
city: Ulm
country: Germany
facility: University of ULM
state: Baden-Wurttemberg
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
Study officials:
affiliation: Sharp Mary Birch Hospital for Women & Newborns
name: Anup C Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katheria AC, Szychowski JM, Essers J, Mendler MR, Dempsey EM, Schmolzer GM, Arnell K, Rich WD, Hassen K, Allman P, Varner M, Cutter GR, Finer N. Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm. J Pediatr. 2020 Aug;223:51-56.e1. doi: 10.1016/j.jpeds.2020.04.010. Epub 2020 May 29.