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NCT00579839 Clinical Trial

Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate

PreTerm Birth Clinical Trial

Official title:
A Randomized Controlled Trial of Immediate Versus Delayed Cord Clamping in the Preterm Neonate

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00579839
Other study ID # CordClampingElimian
Secondary ID
Status Completed
Phase N/A
First received December 18, 2007
Last updated January 19, 2012
Start date October 2006
Est. completion date May 2011

Study information
Verified date January 2012
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.

Description:

This study is intended to be a randomized controlled trial comparing immediate cord clamping which represents the current standard of care at Oklahoma University Medical Center with delayed cord clamping among preterm neonates born between 24 weeks and 34 weeks 0 days weeks' gestation. Allocation sequence will be generated by simple randomization using random number table in the stratum 24-28 weeks 6 days and 29 weeks to 34 weeks 0 days weeks' gestation stratum.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Singleton pregnancies

- Signed consent to participate in the trial

Exclusion Criteria:

- Major fetal anomaly or known fetal chromosomal abnormalities

- Multiple gestation

- Mothers with pregestational and gestational diabetes

- Refusal to participate in the trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Delayed Cord Clamping
Delayed Cord Clamping: 30-35 seconds after birth
• Immediate Cord Clamping
Immediate Cord Clamping: within 5 seconds of birth

Locations
Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation. 2 years No
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