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

This study is currently recruiting participants.
Verified April 2014 by Sharp HealthCare
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare
ClinicalTrials.gov Identifier:
NCT01866982
First received: May 29, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Intraventricular Hemorrhage
Procedure: Umbilical Cord Milking
Procedure: Delayed Cord Clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants

Resource links provided by NLM:


Further study details as provided by Sharp HealthCare:

Primary Outcome Measures:
  • Superior Vena Cava Flow [ Time Frame: <12 hours of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delivery Room Interventions [ Time Frame: 10 minutes of life ] [ Designated as safety issue: Yes ]
  • Hemoglobin [ Time Frame: <1 hour ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Hemoglobin [ Time Frame: 4 weeks of life ] [ Designated as safety issue: No ]
  • Neurodevelopmental impairment 18-36 months [ Time Frame: 18-36 months ] [ Designated as safety issue: No ]
  • Severe intraventricular hemorrhage (grade 3 or 4) [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Phototherapy [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: Yes ]
    Requirement and length of phototherapy

  • Ionotropic support [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
    Requirement and length of ionotropic support

  • Neonatal intensive care unit (NICU) length of stay [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Necrotizing enterocolitis [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Number of blood transfusions while in the neonatal intensive care unit [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Ventilator time [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Apgar score <7 at 5 minutes [ Time Frame: at 5 minutes after birth ] [ Designated as safety issue: No ]
  • Umbilical cord pH < 7.0 [ Time Frame: up to 30 minutes after birth ] [ Designated as safety issue: Yes ]
  • Blood pressure in first 2 hours of admission to neonatal intensive care unit [ Time Frame: 2 hours after birth ] [ Designated as safety issue: No ]
  • Polycythemia [ Time Frame: up to 24 hours of life ] [ Designated as safety issue: Yes ]
  • Neonatal death [ Time Frame: up to 24 weeks of life ] [ Designated as safety issue: No ]
  • Use of uterotonic agents [ Time Frame: up to 1 hour after birth ] [ Designated as safety issue: Yes ]
  • Peak transcutaneous and/or serum bilirubin concentrations [ Time Frame: up to 24 weeks after birt ] [ Designated as safety issue: Yes ]
  • Maternal hemoglobin [ Time Frame: within 48 hours after delivery ] [ Designated as safety issue: Yes ]
  • Intraventricular Hemorrhage detected on Head Ultrasound [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Days on Oxygen [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]
  • Vaginal Delivered infants (no difference in interventions) [ Time Frame: up to 24 weeks after birth ] [ Designated as safety issue: No ]
  • Cerebral Tissue Oxygenation [ Time Frame: Up to 24 hours of life ] [ Designated as safety issue: No ]
  • Cardiac output by electric cardiometry [ Time Frame: up to 24 hours of life ] [ Designated as safety issue: No ]
  • Stroke volume by electric cardiometry [ Time Frame: Up to 24 hours of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Umbilical Cord Milking
Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds
Procedure: Umbilical Cord Milking
Active Comparator: Delayed Cord Clamping
Delayed clamping of the umbilical cord for 45-60 seconds
Procedure: Delayed Cord Clamping

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866982

Contacts
Contact: Anup Katheria, MD 858-9394175 akatheria@ucsd.edu
Contact: Kathy Arnell, RN 858-939-4966 kathy.arnell@sharp.com

Locations
United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Giang Truong, MD       GTTruong@llu.edu   
Principal Investigator: Giang Truong, MD         
Sharp Mary Birch Recruiting
San Diego, California, United States, 92123
Contact: Anup C Katheria, MD    858-939-4175    anup.katheria@sharp.com   
Principal Investigator: Anup C Katheria, MD         
Sub-Investigator: Larry Cousins, MD         
University of California, San Diego Active, not recruiting
San Diego, California, United States, 92130
Sponsors and Collaborators
Sharp HealthCare
Investigators
Principal Investigator: Anup C Katheria, MD Sharp HealthCare
  More Information

No publications provided

Responsible Party: Anup Katheria, M.D., Director of Neonatal Research, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT01866982     History of Changes
Other Study ID Numbers: PREMOD
Study First Received: May 29, 2013
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sharp HealthCare:
umbilical cord milking
delayed cord clamping

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014