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Completed

NCT Number: NCT01434732

Effects of Milking the Umbilical Cord on Systemic Blood Flow

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.

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Key information

Conditions

Abnormal Vascular Flow

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Medical Center

San Diego, California, 92130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Milking

Procedure

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 names: stripping the umbilical cord

Immediate Cord Clamping

Procedure

The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.

Other names: routine clamping of the umbilical cord

Primary outcomes

  1. Superior Vena Cava Flow

    Time frame: 6 hours

    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 outcomes

  1. Blood Pressure

    Time frame: 6 hours of life

    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.

  2. Neurodevelopmental Outcomes

    Time frame: between 18 and 36 months of life

    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.

  3. number of blood transfusions

    Time frame: 36 weeks corrected gestational age

    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.

  4. Superior Vena Cava Flow

    Time frame: 18 hours of life

    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.

  5. Superior Vena Cava Flow

    Time frame: 30 hours of life

    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.

  6. Blood Pressure

    Time frame: at 18 hours of life

    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.

  7. Blood Pressure

    Time frame: 30 hours of life

    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.

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Registry information

Official study title

A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2011
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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