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Adrenaline Injections to Children Born at Elective CS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00322660
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : June 28, 2007
Sponsor:
Information provided by:
Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Hypoglycemia Drug: Adrenaline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline
Study Start Date : June 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia




Primary Outcome Measures :
  1. respiratory distress
  2. hypoglycemia


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322660


Locations
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Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Hvidovre Hospital
Kettegård Alle 31, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00322660    
Other Study ID Numbers: 2005091
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: June 28, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents