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NCT00322660 Clinical Trial

Adrenaline Injections to Children Born at Elective CS

Hypoglycemia Clinical Trial

Official title:
Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00322660
Other study ID # 2005091
Secondary ID
Status Completed
Phase N/A
First received May 5, 2006
Last updated June 27, 2007
Start date June 2006
Est. completion date June 2007

Study information
Verified date June 2007
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 270
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 1 Day
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Adrenaline

Locations
Country Name City State
Denmark Hvidovre University Hospital Copenhagen Hvidovre
Denmark Hvidovre Hospital Kettegård Alle 31 Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Irestedt L, Lagercrantz H, Belfrage P. Causes and consequences of maternal and fetal sympathoadrenal activation during parturition. Acta Obstet Gynecol Scand Suppl. 1984;118:111-5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary respiratory distress
Primary hypoglycemia
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