NCT00322660CompletedNot Applicable
Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline
Hvidovre University Hospital2 sites in 1 country270 target enrollmentStarted: June 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 270
- Locations
- 2
- Primary Endpoint
- respiratory distress
Study Overview
Brief Summary
Children born after elective C-section have a greater risk of respiratory problems and hypoglycemia - most likely due to a lower concentration of stress hormones compared to children born vaginally. Hypothesis: can we eliminate or reduce the risk of respiratory distress and hypoglycaemia by administrating adrenaline to the newborn.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- — to 1 Day (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All children born at elective section with gestational age more than 37 + 0
Exclusion Criteria
- •Children in whom a serious malformation was found during pregnancy assuming this malformation will lead to very early death or respiratory problems.
- •Serious malformations (ex.anencephalia) will be excluded at birth
- •Other malformations will be estimated by investigator whether it will lead to exclusion.
Outcomes
Primary Outcomes
respiratory distress
hypoglycemia
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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