PremedicationPhase 2/3NCT02700893
Cerebral NIRS Profiles During Premedication for Neonatal Intubation
A Phase 2/3 study testing atropine+ propofol and atropine + atracurium + sufentanil in people with Premedication and Endotracheal Intubation, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Premedication, Endotracheal Intubation, Cerebral Hypoperfusion
- What is being tested?
- atropine+ propofol and atropine + atracurium + sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2016to Aug 2016
- Phase
- Phase 2/3
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Corrected age < 45 weeks of gestational age
- Currently hospitalized in a neonatal intensive care unit
- Requiring semi-urgent or elective intubation
- Equipped with a reliable and permeable IV line
- Parental consent
Who cannot join
- Lack of parental consent
- Parental refusal
- Sedative or anesthetic treatment in the previous 24 hours
- Hemodynamic compromise defined as mean blood pressure< corrected GA and/or refill time > 3 seconds
- Upper airway malformation
- Life-threatening situation requiring immediate intubation
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- Inclusion in another trial not permitting any other participation
- Impossibility to establish venous access
- Any contra-indication to any experimental drug
- Skin lesions or burns of the forehead
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital intercommunal de Créteil
Créteil, 94000
Hôpital des enfants
Toulouse, 31059
About this study
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.
Primary outcome:
Read more
- Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication).
- Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.
- Being tested
- atropine+ propofol, atropine + atracurium + sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atropine+ propofolDrug
Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
atropine + atracurium + sufentanilDrug
Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
| Study group | Role | What they receive |
|---|---|---|
| Atropine + propofol | Experimental | Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg Receives: Drug: atropine+ propofol |
| Atropine + atracurium + sufentanil | Active comparator | Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g Receives: Drug: atropine + atracurium + sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral desaturation
rScO2 delta >20% from the baseline value (before premedication). rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection
Measured: from 1 minute before to 60 minutes after the start of premedication
FTOE (Fractional Tissue Oxygen Extraction)
Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded
1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection.
Measured: from 1 minute before to 60 minutes after the start of premedication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PremedicationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne, Centre de Recherche Clinique du CHIC
- Responsible party
- Principal investigator, Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil
- Investigators
- Meryl Vedrenne-Cloquet, MD, Principal investigator, CHI CréteilXavier Durrmeyer, MD, PhD, Study director, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700893
- Sponsor's protocol ID
- PRETTINEO sub-study
- Status last verified
- Aug 2019
- First submitted
- 2 Mar 2016
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019.
PubMed 30881948
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral NIRS Profiles During Premedication for Neonatal Intubation
- ClinicalTrials.gov ID
- NCT02700893
- Acronym / sponsor ID
- PRETTINEO sub-study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Association Clinique Thérapeutique Infantile du val de Marne, Centre de Recherche Clinique du CHIC
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Mar 2016 (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.
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.
Primary outcome:
- Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication).
- Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine + propofol | Experimental | Drug: atropine+ propofolAtropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg |
| Atropine + atracurium + sufentanil | Active comparator | Drug: atropine + atracurium + sufentanilAtropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Corrected age < 45 weeks of gestational age
- Currently hospitalized in a neonatal intensive care unit
- Requiring semi-urgent or elective intubation
- Equipped with a reliable and permeable IV line
- Parental consent
Key exclusion criteria (10 listed)
- Lack of parental consent
- Parental refusal
- Sedative or anesthetic treatment in the previous 24 hours
- Hemodynamic compromise defined as mean blood pressure< corrected GA and/or refill time > 3 seconds
- Upper airway malformation
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+ propofolAtropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg | Drug | Atropine + propofol |
| atropine + atracurium + sufentanilAtropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g | Drug | Atropine + atracurium + sufentanil |
Primary outcome
Cerebral desaturation
Time frame: from 1 minute before to 60 minutes after the start of premedication
rScO2 delta >20% from the baseline value (before premedication). rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection
FTOE (Fractional Tissue Oxygen Extraction)
Time frame: from 1 minute before to 60 minutes after the start of premedication
Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection.
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 9 Aug 2019.
- Results publication: PubMed 30881948Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019.
- Open access articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Meryl Vedrenne-Cloquet, MD principal investigator
CHI Créteil
Xavier Durrmeyer, MD, PhD study director
CHI Créteil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing atropine+ propofol and atropine + atracurium + sufentanil in people with Premedication and Endotracheal Intubation, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
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 5 inclusion and 10 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 9 Aug 2019. 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cerebral desaturation (time frame: from 1 minute before to 60 minutes after the start of premedication). 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 NCT02700893, which also lists 1 linked publication.
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 9 Aug 2019.