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NCT Number: NCT01666847

Milking the Umbilical Cord for Extreme Preterm Infants

Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months.

The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University, Division of Neonatology, SSM Cardinal Glennon Children's Medical Center, St Louis, Missouri, United States

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About this study

Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound
  • informed consent obtained by the pregnant women prior to delivery of the infant.

Exclusion criteria

  • pregnancy with a multiple gestation
  • infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities
  • infants with hydrops fetalis

Treatment and study plan

Milking the umbilical cord before cord clamping

Procedure

The procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant.

Primary outcomes

  1. To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping

    Time frame: Within 4 hour of birth

  2. To evaluate and compare the incidence and numbers of blood transfusions after cord milking

    Time frame: Prior to initial infant discharge

Secondary outcomes

  1. To evaluate and compare blood pressure after intervention and need for support medications

    Time frame: For first seven days of life

  2. To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy

    Time frame: Three weeks

    Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.

  3. To evaluate the incidence of complications of prematurity in the study and control groups

    Time frame: Until 3 years corrected gestational age

  4. To evaluate long term outcomes of prematurity in both groups in a follow-up study

    Time frame: Until 3 years corrected gestational age

  5. To compare the difference in hemoglobin and hematocrit from umbilical cord blood

    Time frame: Within 4 hours of birth

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Aug 16, 2012
Registry last updated
Aug 14, 2019

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

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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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