Trial · NCT01490580

Premedication Trial for Tracheal Intubation of the NEOnate

NCT01490580, Phase 2, Phase 3, Completed, Centre Hospitalier Intercommunal Creteil; results first posted 2019-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Premedication Trial for Tracheal Intubation of the NEOnate. Trials, record NCT01490580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01490580

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Premedication Trial for Tracheal Intubation of the NEOnate
NCT number: NCT01490580
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 173 participants, actual
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Conditions: Premedication, Endotracheal Intubation
Interventions: atropine+ propofol, atropine + atracurium + sufentanil
First posted: 2011-12-13
Last updated: 2021-03-04
Results first posted: 2019-09-13

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With Prolonged Desaturation	During intubation procedure, expected duration 1 to 15 minutes	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.
Secondary	Number of Intubation Attempts	During intubation procedure, expected duration 1 to 15 minutes
Secondary	Duration of Intubation Procedure	Expected duration 1 to 15 minutes	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.
Secondary	Heart Rate	from 1 minute before to 60 minutes after the start of premedication	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
Secondary	Short Term Neurological Outcome: Worsening of Head Ultrasound	Within 7 days after inclusion	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.
Secondary	Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2	At 2 years corrected age	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.
Secondary	Pulse Oxymetry	from 1 minute before to 60 minutes after the start of premedication	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
Secondary	Mean Blood Pressure	from 1 minute before to 60 minutes after the start of premedication	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
Secondary	Transcutaneous PCO2 (TcPCO2) Measurement	from 1 minute before to 60 minutes after the start of premedication	TcPCO2 recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Prolonged Desaturation	During intubation procedure, expected duration 1 to 15 minutes		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Intubation Attempts	During intubation procedure, expected duration 1 to 15 minutes		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Intubation Procedure	Expected duration 1 to 15 minutes		Minutes	MEDIAN
SECONDARY	Heart Rate	from 1 minute before to 60 minutes after the start of premedication		bpm	MEAN
SECONDARY	Short Term Neurological Outcome: Worsening of Head Ultrasound	Within 7 days after inclusion		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2	At 2 years corrected age	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pulse Oxymetry	from 1 minute before to 60 minutes after the start of premedication	Changes in SpO2 value from baseline were analyzed at predefined time points. Data was missing at some time points.	% SpO2	MEAN
SECONDARY	Mean Blood Pressure	from 1 minute before to 60 minutes after the start of premedication	Changes from baseline in mean arterial blood pressure (MAP) were analyzed at predefined time points. Values were missing at some time points.	Difference in mm Hg	MEAN
SECONDARY	Transcutaneous PCO2 (TcPCO2) Measurement	from 1 minute before to 60 minutes after the start of premedication	Changes in TcPCO2 from baseline were analyzed at predefined time points. Values were missing at some time points.	Difference in mm Hg	MEAN

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Patients With Prolonged Desaturation	Atropine Atracurium Sufentanil		54	Participants
Number of Patients With Prolonged Desaturation	Atropine Propofol		53	Participants
Number of Intubation Attempts	Atropine + Propofol	1 attempt	41	Participants
Number of Intubation Attempts	Atropine + Atracurium + Sufentanil	1 attempt	47	Participants
Number of Intubation Attempts	Atropine + Propofol	2 attempts	25	Participants
Number of Intubation Attempts	Atropine + Atracurium + Sufentanil	2 attempts	23	Participants
Number of Intubation Attempts	Atropine + Propofol	> 2 attempts	21	Participants
Number of Intubation Attempts	Atropine + Atracurium + Sufentanil	> 2 attempts	11	Participants
Number of Intubation Attempts	Atropine + Propofol	Missing data	2	Participants
Number of Intubation Attempts	Atropine + Atracurium + Sufentanil	Missing data	1	Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Atropine Atracurium Sufentanil	82
Overall Study	STARTED	Atropine Propofol	91
Overall Study	COMPLETED	Atropine Atracurium Sufentanil	82
Overall Study	COMPLETED	Atropine Propofol	89
Overall Study	NOT COMPLETED	Atropine Atracurium Sufentanil	0
Overall Study	NOT COMPLETED	Atropine Propofol	2

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypotension, not treated	Vascular disorders	Atropine + Propofol	9	83	9
other	Hypotension, not treated	Vascular disorders	Atropine + Atracurium + Sufentanil	1	80	1
other	Hypertension	Vascular disorders	Atropine + Propofol	7	83	7
other	Hypertension	Vascular disorders	Atropine + Atracurium + Sufentanil	7	80	7
other	Bradycardia	Cardiac disorders	Atropine + Propofol	1	83	1
other	Bradycardia	Cardiac disorders	Atropine + Atracurium + Sufentanil	6	80	6
other	Other	General disorders	Atropine + Propofol	12	83	12
other	Other	General disorders	Atropine + Atracurium + Sufentanil	14	80	14
serious	Death	Respiratory, thoracic and mediastinal disorders	Atropine + Propofol	2	83	2
serious	Death	Respiratory, thoracic and mediastinal disorders	Atropine + Atracurium + Sufentanil	3	80	3

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atropine + Propofol	2	83
Total, all-cause mortality	Atropine + Atracurium + Sufentanil	3	80
Total, other adverse events	Atropine + Propofol	25	83
Total, other adverse events	Atropine + Atracurium + Sufentanil	28	80
Total, serious adverse events	Atropine + Propofol	9	83
Total, serious adverse events	Atropine + Atracurium + Sufentanil	16	80

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29715354	RESULT	PubMed
33301785	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Atropine Atracurium Sufentanil vs Atropine Propofol: Number of Patients With Prolonged Desaturation	Trial comparisons
Atropine + Propofol vs Atropine + Atracurium + Sufentanil: deaths from any cause	Trial comparisons
Atropine Atracurium Sufentanil as Treated Population vs Atropine Propofol as Treated Population: Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2	Trial comparisons
Atropine + Propofol vs Atropine + Atracurium + Sufentanil: Short Term Neurological Outcome: Worsening of Head Ultrasound	Trial comparisons
Atropine + Propofol vs Atropine + Atracurium + Sufentanil: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01490580

GET https://conductscience.org/api/trials/v1/NCT01490580/results?page=2

API reference For AI assistants