Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
NCT ID: NCT03019367
Last Updated: 2022-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1201 participants
INTERVENTIONAL
2017-06-06
2022-09-16
Brief Summary
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\* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Umbilical cord milking UCM
Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds.
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.
Delayed cord clamping DCC
Delayed clamping of the umbilical cord for at least 60 seconds.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Multiples without Twin-to-twin Transfusion Syndrome (TTTS)
Exclusion Criteria
* 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
23 Weeks
33 Weeks
ALL
No
Sponsors
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Sharp Mary Birch Hospital for Women & Newborns
OTHER
Loma Linda University
OTHER
University of Pittsburgh
OTHER
Providence Hospital
OTHER
University of Alabama at Birmingham
OTHER
University of Alberta
OTHER
University College Cork
OTHER
University of Ulm
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Christiana Care Health Services
OTHER
Sharp Grossmont Hospital
OTHER
University of Utah
OTHER
University of Mississippi Medical Center
OTHER
PIH Health Good Samaritan Hospital
UNKNOWN
University of California, Irvine
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Cook County Health
OTHER_GOV
St. Louis University
OTHER
LAC+USC Medical Center
OTHER
Sharp HealthCare
OTHER
Responsible Party
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Anup Katheria, M.D.
Director of Neonatal Research Institute
Principal Investigators
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Anup C Katheria, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp HealthCare
Locations
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University of Alabama
Birmingham, Alabama, United States
Loma Linda Medical Center
Loma Linda, California, United States
LAC+USC Medical Center
Los Angeles, California, United States
PIH Health Good Samaritan Hospital
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Sharp Grossmont Hospital
San Diego, California, United States
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
Christiana Care
Newark, Delaware, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis University
St Louis, Missouri, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Governors of University of Alberta
Edmonton, Alberta, Canada
University of ULM
Ulm, Baden-Wurttemberg, Germany
Cork University Maternity Hospital
Cork, , Ireland
Countries
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References
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Katheria AC, Allman P, Szychowski JM, Essers J, Carlo WA, Schmolzer GM, Dempsey E, Yanowitz T, Kaempf J, Vora F, Bhat S, Arnell K, Rich W, Varner M. Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent. Am J Perinatol. 2022 Jun;39(8):904-908. doi: 10.1055/s-0040-1719184. Epub 2020 Nov 3.
Katheria A, Reister F, Essers J, Mendler M, Hummler H, Subramaniam A, Carlo W, Tita A, Truong G, Davis-Nelson S, Schmolzer G, Chari R, Kaempf J, Tomlinson M, Yanowitz T, Beck S, Simhan H, Dempsey E, O'Donoghue K, Bhat S, Hoffman M, Faksh A, Arnell K, Rich W, Finer N, Vaucher Y, Khanna P, Meyers M, Varner M, Allman P, Szychowski J, Cutter G. Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants. JAMA. 2019 Nov 19;322(19):1877-1886. doi: 10.1001/jama.2019.16004.
Related Links
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Website for trial
NIRS Sub-study PREMOD2
Followup Study-PREMOD2
Other Identifiers
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PREMOD2
Identifier Type: -
Identifier Source: org_study_id
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