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The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants (PREMOD)

Primary Purpose

Intraventricular Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Umbilical Cord Milking
Delayed Cord Clamping
Sponsored by
Sharp HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraventricular Hemorrhage focused on measuring umbilical cord milking, delayed cord clamping

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Loma Linda Medical Center
  • Sharp Mary Birch
  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Umbilical Cord Milking

Delayed Cord Clamping

Arm Description

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

Delayed clamping of the umbilical cord for 45-60 seconds

Outcomes

Primary Outcome Measures

Superior Vena Cava Flow

Secondary Outcome Measures

Delivery Room Interventions
Hemoglobin
Hemoglobin
Hemoglobin
Neurodevelopmental impairment 18-36 months
Severe intraventricular hemorrhage (grade 3 or 4)
Phototherapy
Requirement and length of phototherapy
Ionotropic support
Requirement and length of ionotropic support
Neonatal intensive care unit (NICU) length of stay
Necrotizing enterocolitis
Number of blood transfusions while in the neonatal intensive care unit
Ventilator time
Apgar score <7 at 5 minutes
Umbilical cord pH < 7.0
Blood pressure in first 2 hours of admission to neonatal intensive care unit
Polycythemia
Neonatal death
Use of uterotonic agents
Peak transcutaneous and/or serum bilirubin concentrations
Maternal hemoglobin
Intraventricular Hemorrhage detected on Head Ultrasound

Full Information

First Posted
May 29, 2013
Last Updated
May 22, 2018
Sponsor
Sharp HealthCare
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01866982
Brief Title
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Acronym
PREMOD
Official Title
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2, 2013 (Actual)
Primary Completion Date
December 1, 2014 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage
Keywords
umbilical cord milking, delayed cord clamping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical Cord Milking
Arm Type
Active Comparator
Arm Description
Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds
Arm Title
Delayed Cord Clamping
Arm Type
Active Comparator
Arm Description
Delayed clamping of the umbilical cord for 45-60 seconds
Intervention Type
Procedure
Intervention Name(s)
Umbilical Cord Milking
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Delayed Cord Clamping
Intervention Description
Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.
Primary Outcome Measure Information:
Title
Superior Vena Cava Flow
Time Frame
<12 hours of life
Secondary Outcome Measure Information:
Title
Delivery Room Interventions
Time Frame
10 minutes of life
Title
Hemoglobin
Time Frame
<1 hour
Title
Hemoglobin
Time Frame
12 hours
Title
Hemoglobin
Time Frame
4 weeks of life
Title
Neurodevelopmental impairment 18-36 months
Time Frame
18-36 months
Title
Severe intraventricular hemorrhage (grade 3 or 4)
Time Frame
up to 24 weeks after birth
Title
Phototherapy
Description
Requirement and length of phototherapy
Time Frame
up to 24 weeks after birth
Title
Ionotropic support
Description
Requirement and length of ionotropic support
Time Frame
up to 24 weeks after birth
Title
Neonatal intensive care unit (NICU) length of stay
Time Frame
up to 24 weeks after birth
Title
Necrotizing enterocolitis
Time Frame
up to 24 weeks after birth
Title
Number of blood transfusions while in the neonatal intensive care unit
Time Frame
up to 24 weeks after birth
Title
Ventilator time
Time Frame
up to 24 weeks after birth
Title
Apgar score <7 at 5 minutes
Time Frame
at 5 minutes after birth
Title
Umbilical cord pH < 7.0
Time Frame
up to 30 minutes after birth
Title
Blood pressure in first 2 hours of admission to neonatal intensive care unit
Time Frame
2 hours after birth
Title
Polycythemia
Time Frame
up to 24 hours of life
Title
Neonatal death
Time Frame
up to 24 weeks of life
Title
Use of uterotonic agents
Time Frame
up to 1 hour after birth
Title
Peak transcutaneous and/or serum bilirubin concentrations
Time Frame
up to 24 weeks after birt
Title
Maternal hemoglobin
Time Frame
within 48 hours after delivery
Title
Intraventricular Hemorrhage detected on Head Ultrasound
Time Frame
up to 24 weeks after birth
Other Pre-specified Outcome Measures:
Title
Days on Oxygen
Time Frame
during hospitalization
Title
Vaginal Delivered infants (no difference in interventions)
Time Frame
up to 24 weeks after birth
Title
Cerebral Tissue Oxygenation
Time Frame
Up to 24 hours of life
Title
Cardiac output by electric cardiometry
Time Frame
up to 24 hours of life
Title
Stroke volume by electric cardiometry
Time Frame
Up to 24 hours of life

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup C Katheria, MD
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Sharp Mary Birch
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26122803
Citation
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.
Results Reference
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PubMed Identifier
29246467
Citation
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.
Results Reference
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The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants

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