Adrenaline Injections to Children Born at Elective CS

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00322660
First received: May 5, 2006
Last updated: June 27, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Respiratory Distress
Hypoglycemia
Drug: Adrenaline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • respiratory distress
  • hypoglycemia

Enrollment: 270
Study Start Date: June 2006
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00322660

Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Hvidovre Hospital
Kettegård Alle 31, Hvidovre, Denmark, 2650
Sponsors and Collaborators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00322660     History of Changes
Other Study ID Numbers: 2005091
Study First Received: May 5, 2006
Last Updated: June 27, 2007
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014