Respiratory DistressNCT00322660
Adrenaline Injections to Children Born at Elective CS
A study testing Adrenaline in people with Respiratory Distress and Hypoglycemia, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress, Hypoglycemia
- What is being tested?
- Adrenaline
- How many people
- 270 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2006to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children born at elective section with gestational age more than 37 + 0
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
Hvidovre Hospital
Kettegård Alle 31, Hvidovre, 2650
About this study
Official title: Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline
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.
- Conditions
- Respiratory Distress, Hypoglycemia
- Being tested
- Adrenaline
- Medical subject headings
- Dyspnea, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory distress
hypoglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startJun 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lene A Olsen, M.D., Principal investigator, Hvidovre University Hospital, Copenhagen, Kettegaards allé 30, 2650 Hvidovre, DKPernille Pedersen, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322660
- Sponsor's protocol ID
- 2005091
- Status last verified
- Jun 2007
- First submitted
- 5 May 2006
- Last updated
- 28 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.3109/00016348409157136.
PubMed 6587720Pedersen 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.
PubMed 18786961
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline
- ClinicalTrials.gov ID
- NCT00322660
- Acronym / sponsor ID
- 2005091
- Conditions
- Respiratory Distress, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 8 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children born at elective section with gestational age more than 37 + 0
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adrenaline | Drug | – |
Primary outcome
respiratory distress
hypoglycemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2007.
- Background: PubMed 6587720Irestedt 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.
- Derived from this study: PubMed 18786961Pedersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene A Olsen, M.D. principal investigator
Hvidovre University Hospital, Copenhagen, Kettegaards allé 30, 2650 Hvidovre, DK
Pernille Pedersen principal investigator
Hvidovre University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenaline in people with Respiratory Distress and Hypoglycemia, run by Hvidovre University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory distress. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00322660, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2007.