Effects of Milking the Umbilical Cord on Systemic Blood Flow
A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants
1 other identifier
interventional
60
1 country
1
Brief Summary
Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 3, 2011
CompletedFirst Posted
Study publicly available on registry
September 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 9, 2017
October 1, 2017
2.2 years
June 3, 2011
October 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Superior Vena Cava Flow
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 6 hours.
6 hours
Secondary Outcomes (7)
Blood Pressure
6 hours of life
Neurodevelopmental Outcomes
between 18 and 36 months of life
number of blood transfusions
36 weeks corrected gestational age
Superior Vena Cava Flow
18 hours of life
Superior Vena Cava Flow
30 hours of life
- +2 more secondary outcomes
Study Arms (2)
Umbilical Cord Milking
EXPERIMENTALUmbilical Cord Milking involved milking the umbilical cord at birth.
Immediate Cord Clamping
ACTIVE COMPARATORUmbilical cord is clamped soon after birth without any milking of the cord.
Interventions
UCM will be performed by the obstetric team by having the delivering obstetrician hold the infant below the mother's introitus at vaginal delivery or below the level of the incision at cesarean section and having the assistant (the second obstetrician) milk about 20 cm of umbilical cord over 2 seconds and repeating two additional times.
The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.
Eligibility Criteria
You may qualify if:
- infants \< 32 weeks gestation
You may not qualify if:
- obstetrician's refusal to participate
- multiple gestations (if Di-Mo placentation) surrogate delivery
- parental desire for cord blood banking
- major congenital anomalies
- severe maternal illness
- placental abruption or previa
- ruptured uterus at delivery, or hemoperitoneum
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sharp HealthCarelead
Study Sites (1)
UCSD Medical Center
San Diego, California, 92130, United States
Related Publications (3)
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.
PMID: 29246467DERIVEDKatheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014.
PMID: 24709780DERIVEDKatheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20.
PMID: 24560179DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anup C Katheria, M.D.
UCSD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Neonatal Research
Study Record Dates
First Submitted
June 3, 2011
First Posted
September 15, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 9, 2017
Record last verified: 2017-10