Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Procedure: Umbilical cord clamping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A 1<br>Delayed umbilical cord clamping 30-45 seconds. | Procedure: Umbilical cord clamping<br>* Delay of umbilical cord clamping 30 to 45 seconds<br>|
| No Intervention: A 2<br>Immediate umbilibcal cord clamping | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical cord clamping, Preterm infants, Randomized controlled trial, For women giving birth to singleton infants 32 weeks gestational age or less