NCT00322660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2006

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 28, 2007

Status Verified

June 1, 2007

First QC Date

May 5, 2006

Last Update Submit

June 27, 2007

Conditions

Respiratory DistressHypoglycemia

Outcome Measures

Primary Outcomes (2)

  • respiratory distress

  • hypoglycemia

Interventions

AdrenalineDRUG

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children born at elective section with gestational age more than 37 + 0

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hvidovre University Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Hvidovre Hospital

Kettegård Alle 31, Hvidovre, 2650, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 6587720BACKGROUND

  • 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.

    PMID: 18786961DERIVED

MeSH Terms

Conditions

DyspneaHypoglycemia

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Lene A Olsen, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Pernille Pedersen

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 8, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2007

Last Updated

June 28, 2007

Record last verified: 2007-06

Locations

DK(2)