Study Stopped
Logistical reasons
Delayed Cord Clamping in Very Low Birth Weight Infants
DCC
Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedStudy Start
First participant enrolled
April 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2017
CompletedAugust 29, 2017
August 1, 2017
2.1 years
December 15, 2014
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraventricular hemorrhage
Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.
During NICU admission up to 6 months
Secondary Outcomes (4)
Hemoglobin and hematocrit
During NICU admission up to 6 months
Need for blood transfusion
During NICU admission up to 6 months
Bilirubin levels
During NICU admission up to 6 months
Delivery room temperature
Delivery
Study Arms (2)
30 seconds
ACTIVE COMPARATORFor subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery.
60 seconds
EXPERIMENTALFor subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery.
Interventions
For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery
For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2014
First Posted
January 13, 2015
Study Start
April 16, 2015
Primary Completion
May 17, 2017
Study Completion
August 28, 2017
Last Updated
August 29, 2017
Record last verified: 2017-08