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Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2 (PREMOD2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03019367
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : November 23, 2022
Sponsor:
Collaborators:
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
University of Pittsburgh
Providence Hospital
University of Alabama at Birmingham
University of Alberta
University College Cork
University of Ulm
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Christiana Care Health Services
Sharp Grossmont Hospital
University of Utah
University of Mississippi Medical Center
PIH Health Good Samaritan Hospital
University of California, Irvine
Children's Hospital Medical Center, Cincinnati
John H. Stroger Hospital
St. Louis University
LAC+USC Medical Center
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

Study Description
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Brief Summary:

This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC.

* The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.


Condition or disease Intervention/treatment Phase
Intraventricular Haemorrhage Neonatal Death; Neonatal Procedure: Umbilical cord milking UCM Procedure: Delayed cord clamping DCC Not Applicable

Detailed Description:

Aim 1. Compare the incidence of severe intraventricular hemorrhage (IVH) and/or death in premature newborns <33 weeks gestational age (GA) delivered by C/S receiving UCM to those receiving DCC.

Hypothesis1: First demonstrate infants in the UCM group are not inferior to the DCC group (reject H10).

Hypothesis2: If H1 is true, demonstrate lower incidence of severe IVH and/or death in UCM infants compared to DCC.

Aim 2. Compare the safety and efficacy profiles of premature newborns <33 weeks GA delivered by C/S receiving UCM vs. DCC during their hospitalization.

Hypothesis3: UCM group will have a decreased need for resuscitation interventions with no differences in bilirubin or polycythemia compared to DCC.

Hypothesis4: UCM group will have improved blood pressures in the first 24 hours of life compared to DCC.

Aim 3 (exploratory). To compare the outcomes of premature newborns <33 weeks GA delivered by C/S (Cesarean section) (from Aims 1 and 2) with those born by V/D (vaginal delivery) receiving UCM or DCC.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: It is not possible to blind the delivering obstetrician, however all other caregivers will be blinded. The procedure will be documented as "placental transfusion" in the delivery summary or admission-progress notes and all study assessments whether primary (head US) or secondary (neurodevelopmental exams) will be performed by blinded team members.
Primary Purpose: Prevention
Official Title: Premature Infants Receiving Milking or Delayed Cord Clamping: Randomized Controlled Multicenter Non-inferiority Trial
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : September 16, 2022
Actual Study Completion Date : September 16, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Umbilical cord milking UCM
Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds.
 Procedure: Umbilical cord milking UCM
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. This procedure infuses a placental transfusion of blood into the preterm neonate and can be done in 15-20 seconds.
Active Comparator: Delayed cord clamping DCC
Delayed clamping of the umbilical cord for at least 60 seconds.
 Procedure: Delayed cord clamping DCC
At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of severe IVH or death [ Time Frame: Through study completion at death or discharge, up to 6 months corrected gestational age (CGA) ]
    Severe intraventricular hemorrhage of grade 3 or 4 or death


Secondary Outcome Measures :
  1. All Grade IVH [ Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA) ]
    Any intraventricular hemorrhage (grades 1-4)

  2. Severe IVH (Grade 3 or 4) [ Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA) ]
    Severe intraventricular hemorrhage (bleeding in the brain parenchyma and/or ventricular dilation)

  3. Hemoglobin/Hematocrit at 4 hours [ Time Frame: 4 +/- 2 hours of life ]
    hemoglobin/hematocrit

  4. Incidence of Severe IVH or death in infants <28 weeks gestation [ Time Frame: Through study completion at discharge, up to 6 months corrected gestational age (CGA) ]
    Severe intraventricular hemorrhage (grade 3 or 4) in infants born under 28 weeks gestational age

  5. Delivery room interventions [ Time Frame: In the first 10 minutes of life ]
    Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications

  6. Blood pressures in the first 24 hours of life [ Time Frame: In the first 24 hours of life ]
    Blood pressure on admission, 6, 12, 18 and 24 hours of life


Eligibility Criteria
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Ages Eligible for Study:   23 Weeks to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 23 to 32 +6 Gestational age (currently enrolling 29 to 32+6 weeks)
  • Multiples without Twin-to-twin Transfusion Syndrome (TTTS)

Exclusion Criteria:

  • Congenital anomalies
  • Major cardiac defects
  • Placental abruption or previa with hemorrhage
  • Cord prolapse
  • Hydrops
  • Bleeding Accreta
  • Monochorionic multiples with evidence of TTTS
  • Fetal or maternal risk (i.e. compromise)
  • Parents declined study
  • Unlikely to return for 2 yr Follow Up
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019367


Locations
Show Show 18 study locations
Sponsors and Collaborators
Sharp HealthCare
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
University of Pittsburgh
Providence Hospital
University of Alabama at Birmingham
University of Alberta
University College Cork
University of Ulm
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Christiana Care Health Services
Sharp Grossmont Hospital
University of Utah
University of Mississippi Medical Center
PIH Health Good Samaritan Hospital
University of California, Irvine
Children's Hospital Medical Center, Cincinnati
John H. Stroger Hospital
St. Louis University
LAC+USC Medical Center
Investigators
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Principal Investigator: Anup C Katheria, MD Sharp HealthCare
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anup Katheria, M.D., Director of Neonatal Research Institute, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT03019367    
Other Study ID Numbers: PREMOD2
1R01HD088646-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 2 years after primary publication
Access Criteria: An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
Premature infants
Umbilical cord milking
Delayed cord clamping
Intraventricular Hemorrhage
Death
Additional relevant MeSH terms:
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Premature Birth
Hemorrhage
Pathologic Processes
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases