Back to resultsAdrenaline Injections to Children Born at Elective CS
Primary Purpose
Respiratory Distress, Hypoglycemia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Adrenaline
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Distress
Eligibility Criteria
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.
Sites / Locations
- Hvidovre University Hospital
- Hvidovre Hospital
Outcomes
Primary Outcome Measures
respiratory distress
hypoglycemia
Secondary Outcome Measures
Full Information
NCT ID
NCT00322660
First Posted
May 5, 2006
Last Updated
June 27, 2007
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00322660
Brief Title
Adrenaline Injections to Children Born at Elective CS
Official Title
Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress, Hypoglycemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Primary Outcome Measure Information:
Title
respiratory distress
Title
hypoglycemia
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene A Olsen, M.D.
Organizational Affiliation
Hvidovre University Hospital, Copenhagen, Kettegaards allé 30, 2650 Hvidovre, DK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pernille Pedersen
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Hvidovre Hospital
City
Kettegård Alle 31
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
6587720
Citation
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. doi: 10.3109/00016348409157136.
Results Reference
background
PubMed Identifier
18786961
Citation
Pedersen P, Avlund OL, Pedersen BL, Pryds O. Intramuscular adrenaline does not reduce the incidence of respiratory distress and hypoglycaemia in neonates delivered by elective caesarean section at term. Arch Dis Child Fetal Neonatal Ed. 2009 May;94(3):F164-7. doi: 10.1136/adc.2008.138487. Epub 2008 Sep 11.
Results Reference
derived
Learn more about this trial
Adrenaline Injections to Children Born at Elective CS
We'll reach out to this number within 24 hrs