DUC: Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks

• Sponsor: Mount Sinai Hospital, Canada (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00562536
• Collaborator: (none)
• Enrollment: 296
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Procedure: Umbilical cord clamping	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 296 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
• Study Start Date: Nov 1, 2007
• Anticipated Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 1 Delayed umbilical cord clamping 30-45 seconds.	Procedure: Umbilical cord clamping; Delay of umbilical cord clamping 30 to 45 seconds
No Intervention: A 2 Immediate umbilibcal cord clamping

Outcome Measures

Primary Outcome Measures

1. Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis [3 years]

Secondary Outcome Measures

1. Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia. [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5

Sponsors and Collaborators

• Mount Sinai Hospital, Canada

Investigators

• Principal Investigator: Kellie E Murphy, MD MSc, Mount Sinai Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00562536
• Other Study ID Numbers: Mount Sinai Hospital Toronto
• First Posted: Nov 22, 2007
• Last Update Posted: Nov 22, 2007
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: Umbilical cord clamping; Preterm infants; Randomized controlled trial; For women giving birth to singleton infants 32 weeks gestational age or less
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Nov 22, 2007