Adrenaline Injections to Children Born at Elective CS

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00322660
• Collaborator: (none)
• Enrollment: 270
• Locations: 2
• Duration (Months): 12
• Patients Per Site: 135
• Patients Per Site Per Month: 11.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2006
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. respiratory distress []

2. hypoglycemia []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Day
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre University Hospital	Copenhagen	Hvidovre	Denmark	2650
2	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

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00322660
• Other Study ID Numbers: 2005091
• First Posted: May 8, 2006
• Last Update Posted: Jun 28, 2007
• Last Verified: Jun 1, 2007

• Additional relevant MeSH terms: Hypoglycemia; Epinephrine; Racepinephrine; Epinephryl borate

Study Results

No Results Posted as of Jun 28, 2007