Effects of Milking the Umbilical Cord on Systemic Blood Flow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare
ClinicalTrials.gov Identifier:
NCT01434732
First received: June 3, 2011
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Abnormal Vascular Flow
Procedure: Umbilical Cord Milking
Procedure: Immediate Cord Clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants

Resource links provided by NLM:


Further study details as provided by Sharp HealthCare:

Primary Outcome Measures:
  • Superior Vena Cava Flow [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 6 hours of life ] [ Designated as safety issue: No ]
    Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 6 hours of life.

  • Neurodevelopmental Outcomes [ Time Frame: between 18 and 36 months of life ] [ Designated as safety issue: No ]
    Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have improved neurodevelopmental outcomes. Neurodevelopmental follow-up data including cognitive, language, motor, social-emotional, and adaptive behavior composite scores from the Bayley Scales of Infant and Toddler Development (BSID-III) will be recorded when available. The presence of cerebral palsy, hearing and visual impairment will also be recorded when available.

  • number of blood transfusions [ Time Frame: 36 weeks corrected gestational age ] [ Designated as safety issue: No ]
    Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have fewer blood transfusions at 36 weeks corrected gestational age.

  • Superior Vena Cava Flow [ Time Frame: 18 hours of life ] [ Designated as safety issue: No ]
    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 18 hours.

  • Superior Vena Cava Flow [ Time Frame: 30 hours of life ] [ Designated as safety issue: No ]
    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 30 hours.

  • Blood Pressure [ Time Frame: at 18 hours of life ] [ Designated as safety issue: No ]
    Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 18 hours of life.

  • Blood Pressure [ Time Frame: 30 hours of life ] [ Designated as safety issue: No ]
    Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 30 hours of life.


Enrollment: 60
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Umbilical Cord Milking
Umbilical Cord Milking involved milking the umbilical cord at birth.
Procedure: Umbilical Cord Milking
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.
Other Name: stripping the umbilical cord
Active Comparator: Immediate Cord Clamping Procedure: Immediate Cord Clamping
The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.
Other Name: routine clamping of the umbilical cord

Detailed Description:

The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.

This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants < 32 weeks gestation

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434732

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92130
Sponsors and Collaborators
Sharp HealthCare
Investigators
Principal Investigator: Anup C Katheria, M.D. UCSD
  More Information

No publications provided by Sharp HealthCare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anup Katheria, M.D., Director of Neonatal Research, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT01434732     History of Changes
Other Study ID Numbers: CORDMILK
Study First Received: June 3, 2011
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sharp HealthCare:
Superior vena cava flow
umbilical cord milking
hemodynamics
systemic blood flow

ClinicalTrials.gov processed this record on July 22, 2014