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PREMOD2 With Near Infrared Spectroscopy Sub-study (PREMOD2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03145142
Recruitment Status : Active, not recruiting
First Posted : May 9, 2017
Last Update Posted : September 25, 2019
University of Ulm
University College Cork
University of Alberta
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sharp HealthCare

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.

Condition or disease Intervention/treatment Phase
Hypoxia, Brain Premature Birth Procedure: Umbilical cord milking Procedure: Delayed Cord Clamping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREMOD2 NIRS Substudy - A Randomized Trial of Cerebral Oxygen Saturation in Infants Randomized to Umbilical Cord Milking or Delayed Cord Clamping
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : September 17, 2018
Estimated Study Completion Date : December 15, 2024

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.

Primary Outcome Measures :
  1. StO2 - 10M [ Time Frame: 1st 10 minutes of life ]
    Cerebral Tissue Oxygen Saturation in the Delivery Room

Secondary Outcome Measures :
  1. StO2 - 24H [ Time Frame: 1st 24 hours of life ]
    Cerebral Tissue Oxygen Saturation in the NICU

  2. HR - 10M [ Time Frame: 1st 10 minutes of life ]
    Heart Rate in the Delivery Room

  3. HR 24H [ Time Frame: 1st 24 hours of life ]
    Heart rate in the NICU

  4. Blood Pressure NICU [ Time Frame: 2st 24 hours of life ]
    Mean Blood Pressure in the 1st 24 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03145142

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United States, California
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
Canada, Alberta
Governors of University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
University of ULM
Ulm, Baden-Wurttemberg, Germany, 89075
Cork University Maternity Hospital
Cork, Ireland
Sponsors and Collaborators
Sharp HealthCare
University of Ulm
University College Cork
University of Alberta
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Anup C Katheria, MD Sharp Mary Birch Hospital for Women & Newborns

Additional Information:
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Responsible Party: Sharp HealthCare Identifier: NCT03145142     History of Changes
Other Study ID Numbers: PREMOD2 - NIRS Sub-study
1R01HD088646-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sharp HealthCare:
Near-Infrared Spectroscopy
Additional relevant MeSH terms:
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Hypoxia, Brain
Premature Birth
Signs and Symptoms, Respiratory
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases