Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks

Not Applicable

• Conditions: Premature Birth
• Interventions: Procedure: Umbilical cord clamping

• Registration Number: NCT00562536
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-11
• Study Start: 2007-11
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Last Update Submitted: 2007-11-21
• Study First Posted: 2007-11-22
• Last Update Posted: 2007-11-22
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 296

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A 1	Umbilical cord clamping	Delayed umbilical cord clamping 30-45 seconds.

Primary Outcome Measures

Name	Time	Method
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis	3 years

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.	3 years

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada