Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 296
- Locations
- 1
- Primary Endpoint
- Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 50 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
A 1
Delayed umbilical cord clamping 30-45 seconds.
Intervention: Umbilical cord clamping (Procedure)
A 2
Immediate umbilibcal cord clamping
Outcomes
Primary Outcomes
Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis
Time Frame: 3 years
Secondary Outcomes
- Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia.(3 years)