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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in France

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.

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 groups in NCT01490580
Study groupRoleWhat they receive
Atropine + PropofolExperimentalNot described
Receives: Drug: atropine+ propofol
Atropine + atracurium + sufentanilActive comparatorNot described
Receives: Drug: atropine + atracurium + sufentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. Number of Intubation Attempts

    Measured: During intubation procedure, expected duration 1 to 15 minutes

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted13 Dec 2011 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2016
  4. Study completion15 Apr 2020

Resources

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)
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
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 29715354

  • Tauzin 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

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 6 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 9 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients With Prolonged Desaturation (time frame: During intubation procedure, expected duration 1 to 15 minutes). 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 NCT01490580, 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 4 Mar 2021.

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