NCT03145142

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

1.3 years

First QC Date

May 4, 2017

Last Update Submit

December 9, 2021

Conditions

Hypoxia, BrainPremature Birth

Keywords

Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • StO2 - 10M

    Cerebral Tissue Oxygen Saturation in the Delivery Room

    1st 10 minutes of life

Secondary Outcomes (4)

  • StO2 - 24H

    1st 24 hours of life

  • HR - 10M

    1st 10 minutes of life

  • HR 24H

    1st 24 hours of life

  • Blood Pressure NICU

    2st 24 hours of life

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

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

Procedure: Umbilical cord milking

Delayed Cord Clamping

ACTIVE COMPARATOR

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

Procedure: Delayed Cord Clamping

Interventions

Umbilical cord milkingPROCEDURE

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

Umbilical Cord Milking
Delayed Cord ClampingPROCEDURE

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

Delayed Cord Clamping

Eligibility Criteria

Age23 Weeks - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • weeks 0 days to 27 weeks 6 days.
  • Enrolled in PREMOD2 trial.

You may not qualify if:

  • NIRS Device not available
  • Research Personnel not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Governors of University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

University of ULM

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Cork University Maternity Hospital

Cork, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 32482392DERIVED

Related Links

MeSH Terms

Conditions

Hypoxia, BrainPremature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Anup C Katheria, MD

    Sharp Mary Birch Hospital for Women & Newborns

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 9, 2017

Study Start

June 6, 2017

Primary Completion

September 17, 2018

Study Completion

December 15, 2024

Last Updated

December 13, 2021

Record last verified: 2021-12

Locations

US(1)DE(1)CA(1)IE(1)