PREMOD2 With Near Infrared Spectroscopy Sub-study

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.

Conditions

• Hypoxia, Brain
• Premature Birth

Interventions

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

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.

Sponsors & Collaborators

• University of Ulm

  collaborator OTHER

• University College Cork

  collaborator OTHER

• University of Alberta

  collaborator OTHER

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

  collaborator NIH

• Sharp HealthCare

  lead OTHER

Principal Investigators

• Anup C Katheria, MD · Sharp Mary Birch Hospital for Women & Newborns

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

28 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-06

Primary Completion

2018-09-17

Completion

2024-12-15

Countries

• United States
• Canada
• Germany
• Ireland

Study Locations