The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants
NCT ID: NCT01866982
Last Updated: 2018-05-24
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
197 participants
INTERVENTIONAL
2013-07-02
2018-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Umbilical Cord Milking
Milking the umbilical cord 4 times towards the infants at a speed of 20cm/2 seconds
Umbilical Cord Milking
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.
Delayed Cord Clamping
Delayed clamping of the umbilical cord for 45-60 seconds
Delayed Cord Clamping
Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.
Interventions
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Umbilical Cord Milking
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.
Delayed Cord Clamping
Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sharp HealthCare
OTHER
Responsible Party
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Anup Katheria, M.D.
Director of Neonatal Research
Principal Investigators
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Anup C Katheria, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp HealthCare
Locations
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Loma Linda Medical Center
Loma Linda, California, United States
Sharp Mary Birch
San Diego, California, United States
University of California, San Diego
San Diego, California, United States
Countries
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References
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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.
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.
Other Identifiers
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PREMOD
Identifier Type: -
Identifier Source: org_study_id
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