NewbornPhase 4NCT01427985
Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation
A Phase 4 study testing Atropine, Fentanyl, Mivacurium in people with Newborn and Preterm, run by University of Ulm at 1 site in Germany.
Trial summary
The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared. Read more about this study
- Who is it for?
- Ages Up to 44 weeks
- Conditions the study is for
- Newborn, Preterm, Intubation
- What is being tested?
- Atropine, Fentanyl, Mivacurium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Jul 2012
- 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 Up to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborn infant below 44 weeks postmenstrual age
- indication for elective or semi-elective endotracheal Intubation
- parental informed consent
Who cannot join
- emergency intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation
The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.
Read the detailed description
Influence of the following procedures will be examined:
- Application of Atropin
- Application of Fentanyl
- Application of Mivacurium
- possible desaturation and / or bradycardia during intubation attempts
- restoration of arterial oxygen saturation and / or heart rate after succesful intubation
We aim to examine the change of the following parameters by the use of electrical cardiometry:
- stroke volume
- cardiac output
We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .
- Conditions
- Newborn, Preterm, Intubation
- Being tested
- Atropine, Fentanyl, Mivacurium
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine, Fentanyl, MivacuriumDrug
- Atropin 10µg/kg
- Mivacurium 200µg/kg immediately followed by
- Fentanyl 2µg/kg
Atropine, Fentanyl, MivacuriumDrug
- Atropin 10µg/kg
- Fentanyl 2µg/kg, repeat max. two times
- Mivacurium 200µg/kg
| Study group | Role | What they receive |
|---|---|---|
| Relaxation followed by analgosedation | Experimental | Give Atropin, then Mivacurium, immediately followed by Fentanyl Receives: Drug: Atropine, Fentanyl, Mivacurium |
| Analgosedation followed by Relaxation | Active comparator | Give atropin, then Fentanyl, then Mivacurium Receives: Drug: Atropine, Fentanyl, Mivacurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cerebral tissue oxygen saturation during premedication and intubation
A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery.
Measured: from 1 minute before first study drug until 10 minutes after end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Schmid, University of Ulm
- Investigators
- Manuel B Schmid, Dr. med., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427985
- Sponsor's protocol ID
- ULMNEONIRS02
- Status last verified
- Apr 2016
- First submitted
- 31 Aug 2011
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation
- ClinicalTrials.gov ID
- NCT01427985
- Acronym / sponsor ID
- ULMNEONIRS02
- Conditions
- Newborn, Preterm, Intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Sep 2011 (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 purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.
Detailed description
Influence of the following procedures will be examined:
- Application of Atropin
- Application of Fentanyl
- Application of Mivacurium
- possible desaturation and / or bradycardia during intubation attempts
- restoration of arterial oxygen saturation and / or heart rate after succesful intubation
We aim to examine the change of the following parameters by the use of electrical cardiometry:
- stroke volume
- cardiac output
We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation followed by analgosedation | Experimental | Drug: Atropine, Fentanyl, MivacuriumGive Atropin, then Mivacurium, immediately followed by Fentanyl |
| Analgosedation followed by Relaxation | Active comparator | Drug: Atropine, Fentanyl, MivacuriumGive atropin, then Fentanyl, then Mivacurium |
Who may qualify
- Ages
- Up to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- newborn infant below 44 weeks postmenstrual age
- indication for elective or semi-elective endotracheal Intubation
- parental informed consent
Key exclusion criteria (1 listed)
- emergency 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 |
|---|---|---|
| Atropine, Fentanyl, Mivacurium1. Atropin 10µg/kg 2. Mivacurium 200µg/kg immediately followed by 3. Fentanyl 2µg/kg | Drug | Relaxation followed by analgosedation |
| Atropine, Fentanyl, Mivacurium1. Atropin 10µg/kg 2. Fentanyl 2µg/kg, repeat max. two times 3. Mivacurium 200µg/kg | Drug | Analgosedation followed by Relaxation |
Primary outcome
Change of cerebral tissue oxygen saturation during premedication and intubation
Time frame: from 1 minute before first study drug until 10 minutes after end of procedure
A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery.
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 6 Apr 2016.
Related trials for Newborn
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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.
Manuel B Schmid, Dr. med. principal investigator
University of Ulm
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 Atropine, Fentanyl, Mivacurium in people with Newborn and Preterm, run by University of Ulm at 1 site in Germany.
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 1 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 6 Apr 2016. 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 Germany. 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?
Change of cerebral tissue oxygen saturation during premedication and intubation (time frame: from 1 minute before first study drug until 10 minutes after end of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2016.