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Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01523769
First received: December 16, 2011
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord clamping has also been shown to increase the initial hematocrit and decrease the need for red blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33 weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically interfere with neonatal resuscitation. There have been few studies that addressed the active milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as an alternative to delayed cord clamping, has been shown to increase the circulatory blood volume expressed as the hemoglobin value. Active milking of the cord prior to clamping, however, is not considered standard of care and only 1 Japanese randomized control study has reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion as compared with control conditions. Our study aims to test the hypothesis that active milking of the umbilical cord will reduce the need for transfusion in preterm infants.


Condition Intervention
Prematurity
Procedure: Umbilical Cord Milking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants Born Between 24 and 28 6/7 Weeks Gestation, a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • Red blood cell transfusion [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    need for packed red blood cell transfusion in the first 28 days of neonatal life


Secondary Outcome Measures:
  • Volume of blood transfusion [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    total volume of packed RBC's transfused in first 28 days of neonatal life

  • Intraventricular Hemorrhage [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of IVH in first 28 days of neonatal life

  • Days until transfusion [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    number of days until first RBC transfusion in first 28 days of life

  • Respiratory Distress Syndrome [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of RDS in first 28 days of neonatal life

  • Retinopathy of Prematurity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of ROP in first 28 days of neonatal life

  • Chronic Lung Disease [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of CLD in first 28 days of neonatal life

  • Sepsis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of sepsis in first 28 days of neonatal life

  • Necrotizing Enterocolitis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of nec in first 28 days of neonatal life

  • Apgar scores [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    1, 5, and 10 minute Apgars scores

  • cord PH [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    umbilical cord pH immediately after delivery

  • Neonatal resuscitation [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine

  • Initial Hemoglobin/Hematocrit [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Initial neonatal H/H

  • Initial blood pressure [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Initial neonatal blood pressure

  • Neonatal jaundice [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights

  • Neonatal death [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Incidence of neonatal death in the first 28 days of life, age of neonate at death

  • Length of admission [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Length of neonatal admission (up to 28 days)

  • Length of intubation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Length of need for neonatal intubation in first 28 days of life

  • Periventricular Leukomalacia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of PVL in first 28 days of neonatal life

  • Hyperkalemia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    diagnosis of Hyperkalemia in first 28 days of neonatal life


Enrollment: 113
Study Start Date: September 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Control group, the cord was not milked
Experimental: Umbilical Cord Milking
Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery
Procedure: Umbilical Cord Milking
Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery. (The blood remaining in the umbilical cord after delivery is squeezed in the direction from the placenta (remaining inside the uterus) toward the newborn baby.)
Other Name: Umbilical Cord Milking, autotransfusion

Detailed Description:

The proposed design is a randomized controlled trial. Pregnant women at risk for delivering a singleton preterm infant between 24 and 28 weeks gestation will be randomized prior to delivery into one of two treatment arms. Common reasons for needing to be delivered at this early gestational age include but are not limited to: preterm labor not responding to tocolytic medications, incompetent cervix with cervical dilation and no contractions, clinical chorioamnionitis requiring delivery for maternal/fetal benefit, severe preeclampsia, severe growth restriction with a non-reassuring fetal heart rate tracing. The first arm will include active milking of the umbilical cord toward the neonate's umbilicus prior to cord clamping at delivery while the second arm will not include this intervention and will have their respective cord immediately clamped in the usual fashion post delivery (control).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Delivery anticipated between 24 and 28+6 weeks gestation
  • There is enough time from admission to anticipated delivery to properly obtain consent from the patient

Exclusion Criteria:

  • Multifetal gestation
  • Antenatally diagnosed major congenital anomaly
  • Known Rh sensitized pregnancy
  • Hydrops fetalis (any etiology)
  • Known positive maternal Parvovirus titers
  • Elevated peak systolic velocity of the fetal Middle Cerebral Artery (MCA)
  • Clinical suspicion of placental abruption at delivery due to excessive maternal bleeding or uterine hypertonicity
  • Maternal age under 18
  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: NCT01523769

Locations
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Eastern Virginia Medical School
Investigators
Principal Investigator: Margarita deVeciana, MD Eastern Virginia Medical School
  More Information

No publications provided

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01523769     History of Changes
Other Study ID Numbers: EasternVMC
Study First Received: December 16, 2011
Last Updated: January 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
prematurity
umbilical cord milking
delayed cord clamping
neonatal transfusion

ClinicalTrials.gov processed this record on November 25, 2014