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Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00562536
Acronym
DUC
Enrollment
296
Registered
2007-11-22
Start date
2007-11-30
Completion date
2010-11-30
Last updated
2007-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Umbilical cord clamping, Preterm infants, Randomized controlled trial, For women giving birth to singleton infants 32 weeks gestational age or less

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.

Interventions

Delay of umbilical cord clamping 30 to 45 seconds

Sponsors

Mount Sinai Hospital, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis3 years

Secondary

MeasureTime frame
Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.3 years

Countries

Canada

Contacts

Primary ContactKellie E. Murphy, MD MSc
kmurphy@mtsinai.on.ca416 586-8570
Backup ContactKelly Chu, MD
kelly.chu@utoronto.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026