PREMOD2 With Near Infrared Spectroscopy Sub-study (PREMOD2)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Birth; Hypoxia, Brain
• Intervention / Treatment: Procedure: Umbilical cord milking; Procedure: Delayed Cord Clamping

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • Governors of University of Alberta
• Germany
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89075
      • University of Ulm
• Ireland
  • Cork, Ireland
    • Cork University Maternity Hospital
• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Umbilical Cord Milking; Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds.	Procedure: Umbilical 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
Active Comparator: Delayed Cord Clamping; Delayed clamping of the umbilical cord for at least 60 seconds.	Procedure: Delayed 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Alberta; University of Ulm; University College Cork
• Investigators: Principal Investigator: Anup C Katheria, MD, Sharp Mary Birch Hospital for Women & Newborns

Publications and helpful links

General Publications

• 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.

Helpful Links

• PREMOD2 main trial

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): September 17, 2018
• Study Completion (Anticipated): December 15, 2024

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Near-Infrared Spectroscopy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Hypoxia; Hypoxia, Brain
• Other Study ID Numbers: PREMOD2 - NIRS Sub-study; 1R01HD088646-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No