Adrenaline Injections to Children Born at Elective CS

June 27, 2007 updated by: Hvidovre University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, 2650
        • Hvidovre University Hospital
      • Kettegård Alle 31, Hvidovre, Denmark, 2650
        • Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
respiratory distress
hypoglycemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Lene A Olsen, M.D., Hvidovre University Hospital, Copenhagen, Kettegaards allé 30, 2650 Hvidovre, DK
  • Principal Investigator: Pernille Pedersen, Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

June 28, 2007

Last Update Submitted That Met QC Criteria

June 27, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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