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Adrenaline Injections to Children Born at Elective CS

NCT ID: NCT00322660

Last Updated: 2007-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Adrenaline

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Lene A Olsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital, Copenhagen, Kettegaards allé 30, 2650 Hvidovre, DK

Pernille Pedersen

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Hvidovre Hospital

Kettegård Alle 31, Hvidovre, Denmark

Site Status

Countries

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Denmark

References

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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. doi: 10.3109/00016348409157136.

Reference Type BACKGROUND
PMID: 6587720 (View on PubMed)

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. doi: 10.1136/adc.2008.138487. Epub 2008 Sep 11.

Reference Type DERIVED
PMID: 18786961 (View on PubMed)

Other Identifiers

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2005091

Identifier Type: -

Identifier Source: org_study_id