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Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks (DUC)

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status

Unknown

Conditions

Premature Birth

Treatments

Procedure: Umbilical cord clamping

Study type

Interventional

Funder types

Other

Identifiers

NCT00562536
Mount Sinai Hospital Toronto

Details and patient eligibility

About

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.

Enrollment

296 estimated patients

Sex

Female

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

296 participants in 2 patient groups

A 1
Experimental group
Description:
Delayed umbilical cord clamping 30-45 seconds.
Treatment:
Procedure: Umbilical cord clamping
A 2
No Intervention group
Description:
Immediate umbilibcal cord clamping

Trial contacts and locations

1

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Central trial contact

Kelly Chu, MD; Kellie E. Murphy, MD MSc

Data sourced from clinicaltrials.gov

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