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Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

Primary Purpose

Prematurity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Milking group
Immediate cord clamping
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity focused on measuring neonate, umbilical cord, cord milking, prematurity

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm neonates delivered between 24 0/7 and 32 6/7
  • Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
  • Written parental consent

Exclusion Criteria:

  • Multiple gestation pregnancies (twins or higher order multiples)
  • Rh or other antibody sensitization
  • Hydrops fetalis
  • Known major congenital abnormality
  • Suspected abruptio placentae

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immediate umbilical cord clamping

Cord milking group

Arm Description

The umbilical cord will be clamped immediately after delivery.

The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.

Outcomes

Primary Outcome Measures

Hemoglobin during NICU course

Secondary Outcome Measures

1-min Apgar
5 min Apgar
Blood Sugar upon admission to NICU
Temperature on admission to NICU
Cord blood pH
Blood pressure upon admission to NICU
Number of volume challenges in first 24 hours of life
Days requiring ventilation
Neonatal death
Length of hospital stay
Intraventricular hemorrhage
Number and volume of blood transfusions
duration of phototherapy
Maximum serum bilirubin

Full Information

First Posted
October 6, 2011
Last Updated
December 7, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01819532
Brief Title
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks
Official Title
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
extremely poor recruitment & since the study was approved, medical practice has evolved to where cord milking is now common practice.
Study Start Date
September 2011 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
neonate, umbilical cord, cord milking, prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate umbilical cord clamping
Arm Type
Active Comparator
Arm Description
The umbilical cord will be clamped immediately after delivery.
Arm Title
Cord milking group
Arm Type
Experimental
Arm Description
The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.
Intervention Type
Procedure
Intervention Name(s)
Milking group
Intervention Description
The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.
Intervention Type
Procedure
Intervention Name(s)
Immediate cord clamping
Intervention Description
The umbilical cord will be clamped and cut immediately after delivery of the neonate.
Primary Outcome Measure Information:
Title
Hemoglobin during NICU course
Time Frame
within 24 hours of birth and through NICU stay
Secondary Outcome Measure Information:
Title
1-min Apgar
Time Frame
at 1 minute of life
Title
5 min Apgar
Time Frame
at 5 minutes of life
Title
Blood Sugar upon admission to NICU
Time Frame
within 1 hour of birth
Title
Temperature on admission to NICU
Time Frame
within 1 hour of birth
Title
Cord blood pH
Time Frame
within 1 hour of birth
Title
Blood pressure upon admission to NICU
Time Frame
within 1 hour of birth
Title
Number of volume challenges in first 24 hours of life
Time Frame
at 24 hours of birth
Title
Days requiring ventilation
Time Frame
2 months
Title
Neonatal death
Time Frame
6 months
Title
Length of hospital stay
Time Frame
6 months
Title
Intraventricular hemorrhage
Time Frame
6 months
Title
Number and volume of blood transfusions
Time Frame
10 units
Title
duration of phototherapy
Time Frame
1 month
Title
Maximum serum bilirubin
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm neonates delivered between 24 0/7 and 32 6/7 Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age Written parental consent Exclusion Criteria: Multiple gestation pregnancies (twins or higher order multiples) Rh or other antibody sensitization Hydrops fetalis Known major congenital abnormality Suspected abruptio placentae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Bienstock, MD MPH
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

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