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

History of Changes

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:

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

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 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 ClinicalTrials.gov Identifier (NCT Number):

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.

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
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013

To Top