Premature BirthPhase 4NCT00216944
Balanced Anesthesia for Intubation of Premature Infants
A Phase 4 study testing Tracheal intubation for respiratory care in preterm infants in people with Premature Birth, run by Lund University Hospital at 1 site in Sweden.
Trial summary
The study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth
- What is being tested?
- Tracheal intubation for respiratory care in preterm infants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2005to Oct 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- <37 gw at birth
- <72 hours postnatal age, not previously intubated and no analgetics or sedatives the last 12 hours or >72 hours postnatal age, primary or reintubation
- Informed consent from parents
Who cannot join
- Intubation directly postnatally at the delivery room
- Asphyxia (apgar <4 at 10 min, Umb-pH <7,0
- S-Potassium > 6,5
- Major malformations
- Postsurgery intubation
- Included in an other intervention study first week in life
- Other intervention study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study
The study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. In addition a pain scale for prolonged stress/pain for premature neonates in NICU-care will be validated, and the individual pharmacogenetic profile in relation to the need of morphine after the intubation will be investigated. The hypothesis is that balanced anesthesia before intubation facilitates the procedure, decreases the amount of stress and pain related to it, and causes a decreased need for analgesia after the intubation.
- Conditions
- Premature Birth
- Being tested
- Tracheal intubation for respiratory care in preterm infants
- Keywords
- Intubation, premedication
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubation for respiratory care in preterm infantsProcedure or surgery
Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg
Tracheal intubation for respiratory care in preterm infantsProcedure or surgery
Premedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Premedication with atropine and morphine Receives: Procedure: Tracheal intubation for respiratory care in preterm infants |
| 2 | Active comparator | Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil Receives: Procedure: Tracheal intubation for respiratory care in preterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation
Measured: 6-9 months
Secondary outcomes (5)
Pain score at intubation
Measured: 6-9 months
Biochemical stress/pain response
Measured: 6-9 months
Physiological stress/pain response
Measured: 6-9 months
Behavioural stress/pain response
Measured: 6-9 months
Neurophysiological stress/pain response (aEEG)
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionOct 2009
- Study completionOct 2009
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 Premature BirthStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vineta Fellman, Professor, Principal investigator, Lund University and Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216944
- Sponsor's protocol ID
- EUDRACT EU 2004-001583-52
- Status last verified
- Dec 2010
- First submitted
- 15 Sep 2005
- Last updated
- 15 Feb 2010
- Results posted
- No
Publications
Norman E, Wikstrom S, Rosen I, Fellman V, Hellstrom-Westas L. Premedication for intubation with morphine causes prolonged depression of electrocortical background activity in preterm infants. Pediatr Res. 2013 Jan;73(1):87-94. doi: 10.1038/pr.2012.153. Epub 2012 Nov 5.
PubMed 23128421Norman E, Wikstrom S, Hellstrom-Westas L, Turpeinen U, Hamalainen E, Fellman V. Rapid sequence induction is superior to morphine for intubation of preterm infants: a randomized controlled trial. J Pediatr. 2011 Dec;159(6):893-9.e1. doi: 10.1016/j.jpeds.2011.06.003. Epub 2011 Jul 27.
PubMed 21798556
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT00216944
- Acronym / sponsor ID
- EUDRACT EU 2004-001583-52
- Conditions
- Premature Birth
- Keywords
- Intubation, premedication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Sep 2005 (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.
The study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. In addition a pain scale for prolonged stress/pain for premature neonates in NICU-care will be validated, and the individual pharmacogenetic profile in relation to the need of morphine after the intubation will be investigated. The hypothesis is that balanced anesthesia before intubation facilitates the procedure, decreases the amount of stress and pain related to it, and causes a decreased need for analgesia after the intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Tracheal intubation for respiratory care in preterm infantsPremedication with atropine and morphine |
| 2 | Active comparator | Procedure: Tracheal intubation for respiratory care in preterm infantsPremedication with glycopyrronium, thiopental, suxamethonium and remifentanil |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- <37 gw at birth
- <72 hours postnatal age, not previously intubated and no analgetics or sedatives the last 12 hours or >72 hours postnatal age, primary or reintubation
- Informed consent from parents
Key exclusion criteria (7 listed)
- Intubation directly postnatally at the delivery room
- Asphyxia (apgar <4 at 10 min, Umb-pH <7,0
- S-Potassium > 6,5
- Major malformations
- Postsurgery intubation
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 |
|---|---|---|
| Tracheal intubation for respiratory care in preterm infantsPremedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg | Procedure or surgery | 1 |
| Tracheal intubation for respiratory care in preterm infantsPremedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg | Procedure or surgery | 2 |
Primary outcome
Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation
Time frame: 6-9 months
5 secondary outcomes
Pain score at intubation
Time frame: 6-9 months
Biochemical stress/pain response
Time frame: 6-9 months
Physiological stress/pain response
Time frame: 6-9 months
Behavioural stress/pain response
Time frame: 6-9 months
Neurophysiological stress/pain response (aEEG)
Time frame: 6-9 months
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 15 Feb 2010.
- Derived from this study: PubMed 23128421Norman E, Wikstrom S, Rosen I, Fellman V, Hellstrom-Westas L. Premedication for intubation with morphine causes prolonged depression of electrocortical background activity in preterm infants. Pediatr Res. 2013 Jan;73(1):87-94. doi: 10.1038/pr.2012.153. Epub 2012 Nov 5.
- Derived from this study: PubMed 21798556Norman E, Wikstrom S, Hellstrom-Westas L, Turpeinen U, Hamalainen E, Fellman V. Rapid sequence induction is superior to morphine for intubation of preterm infants: a randomized controlled trial. J Pediatr. 2011 Dec;159(6):893-9.e1. doi: 10.1016/j.jpeds.2011.06.003. Epub 2011 Jul 27.
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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.
Vineta Fellman, Professor principal investigator
Lund University and Lund University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tracheal intubation for respiratory care in preterm infants in people with Premature Birth, run by Lund University Hospital at 1 site in Sweden.
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 3 inclusion and 7 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 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation (time frame: 6-9 months). 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 NCT00216944, 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 15 Feb 2010.