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| Name | Class |
|---|---|
| Association Clinique Thérapeutique Infantile du val de Marne | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine + Propofol | Experimental |
| |
| Atropine + atracurium + sufentanil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atropine+ propofol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During intubation procedure, expected duration 1 to 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intubation Attempts | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Durrmeyer, MD | CHI CRETEIL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord | Amiens | 80054 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29715354 | Result | 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. | |
| 33301785 |
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The trial was prematurely interrupted for logistic reasons in July 2016: a fourth drug manufacturing run was necessary because the intralipids had passed their expiration date and funding had run out. During the study period, 755 patients were screened for eligibility, and 173 randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Atropine Atracurium Sufentanil | n=82 allocated to atropine+atracurium+sufentanil
|
| FG001 | Atropine Propofol | n=91 allocated to atropine+propofol
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atropine Atracurium Sufentanil | |
| BG001 | Atropine Propofol | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | During intubation procedure, expected duration 1 to 15 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atropine + Propofol | atropine+ propofol: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension, not treated | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Xavier Durrmeyer | NICU, CHI Créteil | +33145175433 | xavier.durrmeyer@chicreteil.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2018 | Feb 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| D001279 | Atracurium |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| atropine + atracurium + sufentanil | Drug | 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 |
|
| 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 | 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. | 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. | 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 | 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 | 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 | from 1 minute before to 60 minutes after the start of premedication |
| Hôpital Mère-Enfant |
| Bron |
| 69677 |
| France |
| CHU de Caen | Caen | France |
| Centre Hospitalier Intercommunal de Créteil | Créteil | 94000 | France |
| Hôpital des Enfants | Toulouse | 31059 | France |
| Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours | Tours | 37044 | France |
| Result |
| 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. |
Total of all reporting groups
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Median GA at birth [IQR], weeks | Median | Inter-Quartile Range | WEEKS |
|
| Median birth weight [IQR], g | Median | Inter-Quartile Range | GRAMS |
|
| Reason for intubation, n (%) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Intubation Attempts | Posted | Count of Participants | Participants | During intubation procedure, expected duration 1 to 15 minutes |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | Minutes | Expected duration 1 to 15 minutes |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | bpm | from 1 minute before to 60 minutes after the start of premedication |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Within 7 days after inclusion |
|
|
|
| Secondary | 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. | To handle missing data on ASQ scores, we performed multiple imputation with chained equations using the SAS "MI" procedure. The primary analysis was performed on the imputed dataset in the "as treated" study groups. | Posted | Count of Participants | Participants | At 2 years corrected age |
|
|
|
| Secondary | 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 | Changes in SpO2 value from baseline were analyzed at predefined time points. Data was missing at some time points. | Posted | Mean | Standard Deviation | % SpO2 | from 1 minute before to 60 minutes after the start of premedication |
|
|
|
| Secondary | 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 | Changes from baseline in mean arterial blood pressure (MAP) were analyzed at predefined time points. Values were missing at some time points. | Posted | Mean | Standard Deviation | Difference in mm Hg | from 1 minute before to 60 minutes after the start of premedication |
|
|
|
| Secondary | 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 | Changes in TcPCO2 from baseline were analyzed at predefined time points. Values were missing at some time points. | Posted | Mean | Standard Deviation | Difference in mm Hg | from 1 minute before to 60 minutes after the start of premedication |
|
|
|
| 2 |
| 83 |
| 9 |
| 83 |
| 25 |
| 83 |
| EG001 | Atropine + Atracurium + Sufentanil | atropine + atracurium + sufentanil: 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 | 3 | 80 | 16 | 80 | 28 | 80 |
| Cardiac arrest | Cardiac disorders |
|
| Thoracic rigidity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension (treated) | Vascular disorders | Non-systematic Assessment |
|
| OTHER | General disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D044182 | Benzylisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Surgery |
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| Other |
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| > 2 attempts |
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| Missing data |
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| SpO2 from t-1 to t+9, Difference in % |
|
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| Mean arterial blood pressure from t-1 to t+30 |
|
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| TcPCO2 from t-1 to t+30 |
|
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