PREMOD2 With Near Infrared Spectroscopy Sub-study

NCT ID: NCT03145142

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2024-12-15

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.

Conditions

Hypoxia, Brain; Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Umbilical Cord Milking

Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds.

Group Type: ACTIVE_COMPARATOR

Umbilical cord milking

Intervention Type: PROCEDURE

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

Delayed Cord Clamping

Delayed clamping of the umbilical cord for at least 60 seconds.

Group Type: ACTIVE_COMPARATOR

Delayed Cord Clamping

Intervention Type: PROCEDURE

At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 28 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: collaborator

University College Cork

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Sharp HealthCare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anup C Katheria, MD

Role: PRINCIPAL_INVESTIGATOR

Sharp Mary Birch Hospital for Women & Newborns

Locations

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

Countries

United States; Canada; Germany; Ireland

References

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.

Reference Type: DERIVED

PMID: 32482392 (View on PubMed)

Related Links

https://clinicaltrials.gov/show/NCT03019367

PREMOD2 main trial

Other Identifiers

1R01HD088646-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PREMOD2 - NIRS Sub-study

Identifier Type: -

Identifier Source: org_study_id