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

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ClinicalTrials.gov Identifier: NCT03019367
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : June 20, 2019
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
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

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 consequently allowed for continuation of the trial in infants 30-32+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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 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
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.




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



Information from the National Library of Medicine

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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
  • Multiples unless monochorionic

Exclusion Criteria:

  • Congenital anomalies
  • Major cardiac defects
  • Placental abruption or previa with hemorrhage
  • Cord prolapse
  • Hydrops
  • Bleeding Accreta
  • Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)
  • Fetal or maternal risk (i.e. compromise)
  • Parents declined study
  • Unlikely to return for 2 yr Follow Up

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


Contacts
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Contact: Anup C Katheria, MD 858 939-4170 anup.katheria@sharp.com
Contact: Kathy M Arnell, RN 858 939-4966 kathy.arnell@sharp.com

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294-0004
Contact: Wally Carlo, MD       wcarlo@peds.uab.edu   
Contact: Akila Subramaniam, MD       asubramaniam@uabmc.edu   
United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Giang Truong, MD       GTTruong@llu.edu   
Contact: Shareece Davis-Nelson, MD       SHDavis@llu.edu   
Principal Investigator: Giang Truong, MD         
Sub-Investigator: Shareece Davis-Nelson, MD         
Sharp Grossmont Hospital Recruiting
San Diego, California, United States, 91942
Contact: Anup Katheria, MD       anup.katheria@sharp.com   
Contact: Kevin Fulford, MD       Kevin.fulford@sharp.com   
Sharp Mary Birch Hospital for Women and Newborns Recruiting
San Diego, California, United States, 92123
Contact: Anup Katheria, MD    858-939-4198    anup.katheria@sharp.com   
Contact: Kathy Arnell, RN    858 939 4966    kathy.arnell@sharp.com   
Principal Investigator: Anup Katheria, MD         
United States, Delaware
Christiana Care Active, not recruiting
Newark, Delaware, United States, 19718
United States, Oregon
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225-6603
Contact: Joseph Kaempf, MD       Joseph.Kaempf@providence.org   
Contact: Mark Tomlinson, MD       Mark.Tomlinson@providence.org   
United States, Pennsylvania
Magee-Womens Hospital Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Erin Clark, MD       erin.clark@hsc.utah.edu   
Contact: Tara DuPont, MD       tara.dupont@hsc.utah.edu   
Canada, Alberta
Governors of University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Georg Schmolzer, MD       georg.schmoelzer@me.com   
Contact: Radha Chari, MD       radha.chari@albertahealthservices.ca   
Germany
University of ULM Recruiting
Ulm, Baden-Wurttemberg, Germany, 89075
Contact: Helmut Hummler, MD       helmut.hummler@uni-ulm.de   
Contact: Frank Reister, MD       Frank.reister@uniklinik-ulm.de   
Ireland
Cork University Maternity Hospital Recruiting
Cork, Ireland
Contact: Eugene Dempsey, MD       G.Dempsey@ucc.ie   
Contact: Keelin O'Donoghue, MD       K.Odonoghue@ucc.ie   
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
Investigators
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Principal Investigator: Anup C Katheria, MD Sharp HealthCare

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     History of Changes
Other Study ID Numbers: PREMOD2
1R01HD088646-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
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