Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
Primary Purpose
Prematurity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Umbilical Cord Milking
Sponsored by

About this trial
This is an interventional treatment trial for Prematurity focused on measuring prematurity, umbilical cord milking, delayed cord clamping, neonatal transfusion
Eligibility 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
Sites / Locations
- Eastern Virginia Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Umbilical Cord Milking
Arm Description
Control group, the cord was not milked
Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery
Outcomes
Primary Outcome Measures
Red blood cell transfusion
need for packed red blood cell transfusion in the first 28 days of neonatal life
Secondary Outcome Measures
Volume of blood transfusion
total volume of packed RBC's transfused in first 28 days of neonatal life
Intraventricular Hemorrhage
diagnosis of IVH in first 28 days of neonatal life
Days until transfusion
number of days until first RBC transfusion in first 28 days of life
Respiratory Distress Syndrome
diagnosis of RDS in first 28 days of neonatal life
Retinopathy of Prematurity
diagnosis of ROP in first 28 days of neonatal life
Chronic Lung Disease
diagnosis of CLD in first 28 days of neonatal life
Sepsis
diagnosis of sepsis in first 28 days of neonatal life
Necrotizing Enterocolitis
diagnosis of nec in first 28 days of neonatal life
Apgar scores
1, 5, and 10 minute Apgars scores
cord PH
umbilical cord pH immediately after delivery
Neonatal resuscitation
Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine
Initial Hemoglobin/Hematocrit
Initial neonatal H/H
Initial blood pressure
Initial neonatal blood pressure
Neonatal jaundice
Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights
Neonatal death
Incidence of neonatal death in the first 28 days of life, age of neonate at death
Length of admission
Length of neonatal admission (up to 28 days)
Length of intubation
Length of need for neonatal intubation in first 28 days of life
Periventricular Leukomalacia
diagnosis of PVL in first 28 days of neonatal life
Hyperkalemia
diagnosis of Hyperkalemia in first 28 days of neonatal life
Full Information
NCT ID
NCT01523769
First Posted
December 16, 2011
Last Updated
January 30, 2012
Sponsor
Eastern Virginia Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01523769
Brief Title
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Virginia Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
prematurity, umbilical cord milking, delayed cord clamping, neonatal transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group, the cord was not milked
Arm Title
Umbilical Cord Milking
Arm Type
Experimental
Arm Description
Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery
Intervention Type
Procedure
Intervention Name(s)
Umbilical Cord Milking
Other Intervention Name(s)
Umbilical Cord Milking, autotransfusion
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Red blood cell transfusion
Description
need for packed red blood cell transfusion in the first 28 days of neonatal life
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Volume of blood transfusion
Description
total volume of packed RBC's transfused in first 28 days of neonatal life
Time Frame
28 days
Title
Intraventricular Hemorrhage
Description
diagnosis of IVH in first 28 days of neonatal life
Time Frame
28 days
Title
Days until transfusion
Description
number of days until first RBC transfusion in first 28 days of life
Time Frame
28 days
Title
Respiratory Distress Syndrome
Description
diagnosis of RDS in first 28 days of neonatal life
Time Frame
28 days
Title
Retinopathy of Prematurity
Description
diagnosis of ROP in first 28 days of neonatal life
Time Frame
28 days
Title
Chronic Lung Disease
Description
diagnosis of CLD in first 28 days of neonatal life
Time Frame
28 days
Title
Sepsis
Description
diagnosis of sepsis in first 28 days of neonatal life
Time Frame
28 days
Title
Necrotizing Enterocolitis
Description
diagnosis of nec in first 28 days of neonatal life
Time Frame
28 days
Title
Apgar scores
Description
1, 5, and 10 minute Apgars scores
Time Frame
10 minutes
Title
cord PH
Description
umbilical cord pH immediately after delivery
Time Frame
1 hour
Title
Neonatal resuscitation
Description
Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine
Time Frame
1 hour
Title
Initial Hemoglobin/Hematocrit
Description
Initial neonatal H/H
Time Frame
1 day
Title
Initial blood pressure
Description
Initial neonatal blood pressure
Time Frame
1 day
Title
Neonatal jaundice
Description
Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights
Time Frame
28 days
Title
Neonatal death
Description
Incidence of neonatal death in the first 28 days of life, age of neonate at death
Time Frame
28 days
Title
Length of admission
Description
Length of neonatal admission (up to 28 days)
Time Frame
28 days
Title
Length of intubation
Description
Length of need for neonatal intubation in first 28 days of life
Time Frame
28 days
Title
Periventricular Leukomalacia
Description
diagnosis of PVL in first 28 days of neonatal life
Time Frame
28 days
Title
Hyperkalemia
Description
diagnosis of Hyperkalemia in first 28 days of neonatal life
Time Frame
28 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita deVeciana, MD
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
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Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
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