PremedicationPhase 2/3PRETTINEONCT01490580
Premedication Trial for Tracheal Intubation of the NEOnate
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 6 sites in France.
Trial summary
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: pulse oxymetry value < 80% for more than 60 seconds. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Premedication, Endotracheal Intubation
- What is being tested?
- atropine+ propofol and atropine + atracurium + sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 6 sitesFrance
- Study dates
- May 2012to 15 Apr 2020
- Phase
- Phase 2/3
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
Show all 9Show fewer
- Inclusion in another trial not permitting any other participation
- Impossibility to establish venous access
- Any contra-indication to any experimental drug
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord
Amiens, 80054
Hôpital Mère-Enfant
Bron, 69677
CHU de Caen
Caen
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Hôpital des Enfants
Toulouse, 31059
Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours
Tours, 37044
About this study
Official title: Double Blind Randomized Controlled Trial Comparing "Atropine+Propofol" Versus "Atropine+Atracurium+Sufentanil" as a Premedication Prior to Semi-urgent or Elective Endotracheal Intubation of Term and Preterm Newborns
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: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome.
Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.
- Conditions
- Premedication, Endotracheal Intubation
- Being tested
- atropine+ propofol, atropine + atracurium + sufentanil
- Keywords
- Pain, Newborn, Anaesthesia, opioids, propofol, neuromuscular blocker, atropine
- Medical subject headings
- Pain
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 | Not described Receives: Drug: atropine+ propofol |
| Atropine + atracurium + sufentanil | Active comparator | Not described Receives: Drug: atropine + atracurium + sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Prolonged Desaturation
Pulse oxymetry value measured by Masimo technology below 80% for 60 seconds or more.
Duration of intubation is defined by the time between first laryngoscope insertion and last laryngoscope removal after successful intubation. Successful intubation is defined by clear bilateral breath sounds, increasing heart rate and saturation (if previously low) and appropriate flow curves on the ventilator.
Measured: During intubation procedure, expected duration 1 to 15 minutes
Secondary outcomes (8)
Number of Intubation Attempts
Measured: During intubation procedure, expected duration 1 to 15 minutes
Duration of Intubation Procedure
Although the initial definition of procedure duration in the registered protocol was the time between the first laryngoscope insertion and last laryngoscope removal after successful intubation, the variable collected in the clinical research form was defined as the time between first laryngoscope insertion and the fixation of the tube with tape.
Measured: Expected duration 1 to 15 minutes
Heart Rate
Heart rate recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
Measured: from 1 minute before to 60 minutes after the start of premedication
Short Term Neurological Outcome: Worsening of Head Ultrasound
Worsening of head ultrasound scans in the 7 days after intubation from the preinclusion evaluation, defined as either a normal scan before inclusion and any grade intraventricular hemorrhage (IVH) afterwards, or as a preinclusion grade 1 or 2 IVH scan deteriorating to grade 3 or 4 IVH, according to Papile's classification; This analysis was not centralized but performed in each center according to its usual protocols.
Measured: Within 7 days after inclusion
Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2
Survival without risk of neurodevelopmental delay. Risk of neurodevelopmental delay was defined as no Ages and Stages Questionnaires (ASQ) domain score below threshold (-2 SD) at 2 years of corrected age. The ASQ includes 30 items in 5 neurodevelopmental domains: communication abilities, gross motor skills, fine motor skills, problem solving abilities, and personal-social skills. For each domain, the score obtained by the sum of the items ranges from 0 to 60 and the overall maximum ASQ score is 300 points. For each domain, the score can be categorized using established screening thresholds: an ASQ score <-2 SD below the mean suggests a risk of neurodevelopmental delay in that domai.
Measured: At 2 years corrected age
Pulse Oxymetry
Pulse oxymetry recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
Measured: from 1 minute before to 60 minutes after the start of premedication
Mean Blood Pressure
Blood pressure recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
Measured: from 1 minute before to 60 minutes after the start of premedication
Transcutaneous PCO2 (TcPCO2) Measurement
TcPCO2 recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first 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 posted13 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionAug 2016
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- 173 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
- Responsible party
- Principal investigator, Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil
- Investigators
- Xavier Durrmeyer, MD, Principal investigator, CHI CRETEIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490580
- Sponsor's protocol ID
- PRETTINEO
- Acronym
- PRETTINEO
- Status last verified
- Feb 2021
- First submitted
- 8 Dec 2011
- Last updated
- 4 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.
PubMed 29715354Tauzin M, Marchand-Martin L, Lebeaux C, Breinig S, Claris O, Tourneux P, Alexandre C, Levy C, Jung C, Dechartres A, Durrmeyer X; PREmedication Trial for Tracheal Intubation of the NEOnate Research Group. Neurodevelopmental Outcomes after Premedication with Atropine/Propofol vs Atropine/Atracurium/Sufentanil for Neonatal Intubation: 2-Year Follow-Up of a Randomized Clinical Trial. J Pediatr. 2021 Apr;231:273-277.e3. doi: 10.1016/j.jpeds.2020.12.001. Epub 2020 Dec 8.
PubMed 33301785