Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks

Premature Birth Clinical Trial

— DUC  

Official title:

Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00562536
• Other study ID #: Mount Sinai Hospital Toronto
• Status: Not yet recruiting
• Phase: N/A
• First received: November 21, 2007
• Last updated: November 21, 2007
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2007
• Source: Mount Sinai Hospital, Canada
• Contact: Kellie E. Murphy, MD MSc
• Phone: 416 586-8570
• Email: kmurphy[@]mtsinai.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.

Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 296
• Est. completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.

• Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).

Exclusion Criteria:

• Moderate to life threatening fetal anomalies

• Multiple live gestations at birth (e.g. twins, triplets, etc)

• Intrauterine fetal demise

• Previous participation

• Stem cell collection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth

Intervention

Procedure:
• Umbilical cord clamping
Delay of umbilical cord clamping 30 to 45 seconds

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis		3 years
Secondary	Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.		3 years