Adrenaline Injections to Children Born at Elective CS - Full Text View

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00322660

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

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Epinephrine bitartrate Epinephrine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322660

Locations

Denmark, Hvidovre
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 Hospital

More Information

Publications:

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Sep 11.

Study ID Numbers:	2005091
Study First Received:	May 5, 2006
Last Updated:	June 27, 2007
ClinicalTrials.gov Identifier:	NCT00322660 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Neurotransmitter Agents
Metabolic Diseases
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Adrenergic Agents
Anti-Asthmatic Agents
Cardiovascular Agents
Hypoglycemia

Adrenergic Agonists
Mydriatics
Vasoconstrictor Agents
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Epinephrine
Bronchodilator Agents
Metabolic Disorder

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Metabolic Diseases
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents

Hypoglycemia
Adrenergic Agonists
Pharmacologic Actions
Mydriatics
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Epinephrine
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009