Delayed Cord Clamping in VLBW Infants
Primary Purpose
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard Cord Clamping
Delayed Cord Clamping
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity
Eligibility Criteria
Inclusion Criteria:
- Infants born at participating centers at 24-27 weeks gestation
- Singletons
- Obstetrician approval for enrollment
- Parental consent
Exclusion Criteria:
- Prenatally diagnosed major congenital anomalies
- Intent to withhold or withdraw care
- Significant bleeding due to placenta previa or abruption
Sites / Locations
- University of Alabama
- Cincinnati Children's Medical Center
- Case Western Reserve University, Rainbow Babies and Children's Hospital
- Brown University, Women & Infants Hospital of Rhode Island
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Cord Clamping
Delayed Cord Clamping
Arm Description
Outcomes
Primary Outcome Measures
Infants enrolled
Number of infants enrolled in the pilot within 6 months.
Secondary Outcome Measures
Intention to treat
Identify obstetricians willing to participate in randomizing subjects.
Hematocrit level
Arterial blood pressure
Use of volume expansion or pressor therapy
Blood transfusions
Full Information
NCT ID
NCT01222364
First Posted
October 14, 2010
Last Updated
September 22, 2017
Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT01222364
Brief Title
Delayed Cord Clamping in VLBW Infants
Official Title
Delayed Cord Clamping in VLBW Infants Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
December 2000 (Actual)
Study Completion Date
December 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.
Detailed Description
This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.
This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Cord Clamping
Arm Type
Active Comparator
Arm Title
Delayed Cord Clamping
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Standard Cord Clamping
Intervention Description
Immediate clamping (<5 seconds) of the umbilical cord after delivery.
Intervention Type
Procedure
Intervention Name(s)
Delayed Cord Clamping
Intervention Description
Clamping of the umbilical cord at 30-45 seconds after birth.
Primary Outcome Measure Information:
Title
Infants enrolled
Description
Number of infants enrolled in the pilot within 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Intention to treat
Description
Identify obstetricians willing to participate in randomizing subjects.
Time Frame
6 months
Title
Hematocrit level
Time Frame
4 hours of age
Title
Arterial blood pressure
Time Frame
12 hours of age
Title
Use of volume expansion or pressor therapy
Time Frame
24 hours of age
Title
Blood transfusions
Time Frame
Until hospital discharge or 120 days of life
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Minute
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infants born at participating centers at 24-27 weeks gestation
Singletons
Obstetrician approval for enrollment
Parental consent
Exclusion Criteria:
Prenatally diagnosed major congenital anomalies
Intent to withhold or withdraw care
Significant bleeding due to placenta previa or abruption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Oh, MD
Organizational Affiliation
Brown University, Women & Infants Hospital of Rhode Island
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Avroy A. Fanaroff, MD
Organizational Affiliation
Case Western Reserve University, Rainbow Babies and Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward F. Donovan, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldemar A. Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-7335
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University, Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Brown University, Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
Links:
URL
http://neonatal.rti.org/
Description
NICHD Neonatal Research Network
Learn more about this trial
Delayed Cord Clamping in VLBW Infants
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