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Delayed Cord Clamping in Very Low Birth Weight Infants (DCC)

Primary Purpose

Very Low Birth Weight Infants, Premature Infants, Intraventricular Hemorrhage

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed cord clamping at 30 seconds
Delayed cord clamping at 60 seconds
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Very Low Birth Weight Infants focused on measuring delayed cord clamping

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women who are expected to deliver a very low birth weight infant
  • Neonates born weighing >= 500g and <1500 grams
  • Mother 18 years of age or older
  • English speaking mother

Exclusion Criteria:

  • Placental abruption
  • Vasa previa
  • Fetal hydrops or other signs of fetal volume overload
  • Other major fetal anomalies
  • Placenta Accreta
  • Mother < 18 years of age
  • Non-English speaking mother
  • Infants >= 1500g (3.3 lbs) or <500g

Sites / Locations

  • University of Chicago Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

30 seconds

60 seconds

Arm Description

For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery.

For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery.

Outcomes

Primary Outcome Measures

Intraventricular hemorrhage
Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.

Secondary Outcome Measures

Hemoglobin and hematocrit
Neonates will be followed for up to 6-months and initial H/H will be recorded.
Need for blood transfusion
Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion.
Bilirubin levels
Neonates will be followed for up to 6-months and assessed for clinical jaundice.
Delivery room temperature
Neonates will be assessed for hypothermia at the time of delivery.

Full Information

First Posted
December 15, 2014
Last Updated
August 28, 2017
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02337088
Brief Title
Delayed Cord Clamping in Very Low Birth Weight Infants
Acronym
DCC
Official Title
Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Logistical reasons
Study Start Date
April 16, 2015 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.
Detailed Description
Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood. Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping. Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infants, Premature Infants, Intraventricular Hemorrhage
Keywords
delayed cord clamping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 seconds
Arm Type
Active Comparator
Arm Description
For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery.
Arm Title
60 seconds
Arm Type
Experimental
Arm Description
For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery.
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping at 30 seconds
Intervention Description
For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping at 60 seconds
Intervention Description
For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery
Primary Outcome Measure Information:
Title
Intraventricular hemorrhage
Description
Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.
Time Frame
During NICU admission up to 6 months
Secondary Outcome Measure Information:
Title
Hemoglobin and hematocrit
Description
Neonates will be followed for up to 6-months and initial H/H will be recorded.
Time Frame
During NICU admission up to 6 months
Title
Need for blood transfusion
Description
Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion.
Time Frame
During NICU admission up to 6 months
Title
Bilirubin levels
Description
Neonates will be followed for up to 6-months and assessed for clinical jaundice.
Time Frame
During NICU admission up to 6 months
Title
Delivery room temperature
Description
Neonates will be assessed for hypothermia at the time of delivery.
Time Frame
Delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women who are expected to deliver a very low birth weight infant Neonates born weighing >= 500g and <1500 grams Mother 18 years of age or older English speaking mother Exclusion Criteria: Placental abruption Vasa previa Fetal hydrops or other signs of fetal volume overload Other major fetal anomalies Placenta Accreta Mother < 18 years of age Non-English speaking mother Infants >= 1500g (3.3 lbs) or <500g
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Delayed Cord Clamping in Very Low Birth Weight Infants

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