NCT01866982

Brief Summary

Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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 29, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

July 2, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

May 29, 2013

Last Update Submit

May 22, 2018

Conditions

Intraventricular Hemorrhage

Keywords

umbilical cord milkingdelayed cord clamping

Outcome Measures

Primary Outcomes (1)

  • Superior Vena Cava Flow

    <12 hours of life

Secondary Outcomes (21)

  • Delivery Room Interventions

    10 minutes of life

  • Hemoglobin

    <1 hour

  • Hemoglobin

    12 hours

  • Hemoglobin

    4 weeks of life

  • Neurodevelopmental impairment 18-36 months

    18-36 months

  • +16 more secondary outcomes

Other Outcomes (5)

  • Days on Oxygen

    during hospitalization

  • Vaginal Delivered infants (no difference in interventions)

    up to 24 weeks after birth

  • Cerebral Tissue Oxygenation

    Up to 24 hours of life

  • +2 more other outcomes

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds

Procedure: Umbilical Cord Milking

Delayed Cord Clamping

ACTIVE COMPARATOR

Delayed clamping of the umbilical cord for 45-60 seconds

Procedure: Delayed Cord Clamping

Interventions

Umbilical Cord MilkingPROCEDURE

Umbilical cord milked toward the neonate four times at a speed of 20cm/2seconds, prior to clamping and cutting umbilical cord. Procedure takes about 10-20 seconds.

Umbilical Cord Milking
Delayed Cord ClampingPROCEDURE

Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.

Delayed Cord Clamping

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 - 31 6/7 weeks gestation

You may not qualify if:

  • Planned vaginal breech delivery
  • Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
  • Fetal death in utero
  • Red cell isoimmunization
  • Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
  • Placenta accreta or abruption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Loma Linda Medical Center

Loma Linda, California, 92350, United States

Location

Sharp Mary Birch

San Diego, California, 92123, United States

Location

University of California, San Diego

San Diego, California, 92130, United States

Location

Related Publications (2)

  • Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368.

    PMID: 26122803BACKGROUND

  • Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.

    PMID: 29246467BACKGROUND

MeSH Terms

Interventions

Umbilical Cord Clamping

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Anup C Katheria, MD

    Sharp HealthCare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neonatal Research

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

July 2, 2013

Primary Completion

December 1, 2014

Study Completion

January 10, 2018

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

US(3)