Une analgésie de choix pour l'intubation des nouveau-nés : Etude multicentrique randomisée comparant le rémifentanil à l'association morphine-midazolam

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014256-30-BE

Enrollment

100

Registered

2009-08-18

Start date

2009-09-11

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm newborn & newborm requiring an elective endotacheal intubation MedDRA version: 12.0 Level: LLT Classification code 10067450 Term: Endotracheal intubation

Interventions

Trade Name: Ultiva Pharmaceutical Form: Powder for injection* CAS Number: 132539-07-2 Other descriptive name: REMIFENTANIL HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Every newborn admitted in the NICU with a gestational age equal or greater than 28 weeks and needing non-urgent endothracheal intubation for different pathologies (eg. Respiratory distress, infection, cardiorespiratory insufficiency) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Newborns : a) With a gestational age lower than 28 weeks. b) Needing endothracheal intubation in an emergency c) With severe intraventricular hemorragy (grade 3-4)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to compare the effectiveness of the premedication with remifentanil with respect to the premedication using morphine and midazolam ( in the unit) during the non urgent endotracheal intubation of newborns at term or premature admitted in te NICU.;Secondary Objective: The secondary objectives of the trial are to compare a) the antalgic response during the intubation (via pain assessment) b) the duration of the ventilation-extubation phases c) the number of tentatives before successful intubation d) the morbidity (on the lungs…….. e) the global tolerance (evaluation of heart rate, respiratory frequency, blood pressure…) when using premedications rémifentanil and morphine-modazolam. ;Primary end point(s): The Primary End Point of the trial is to prove that the quality of intubation in newborns (measured by the validated score of Viby-Mogensen ) using remifantanil as premedication is not lower than by using the current combination of morphine-midazolam.	—

Measure

Time frame

Main Objective: The main objective of the trial is to compare the effectiveness of the premedication with remifentanil with respect to the premedication using morphine and midazolam ( in the unit) during the non urgent endotracheal intubation of newborns at term or premature admitted in te NICU.;Secondary Objective: The secondary objectives of the trial are to compare a) the antalgic response during the intubation (via pain assessment) b) the duration of the ventilation-extubation phases c) the number of tentatives before successful intubation d) the morbidity (on the lungs…….. e) the global tolerance (evaluation of heart rate, respiratory frequency, blood pressure…) when using premedications rémifentanil and morphine-modazolam. ;Primary end point(s): The Primary End Point of the trial is to prove that the quality of intubation in newborns (measured by the validated score of Viby-Mogensen ) using remifantanil as premedication is not lower than by using the current combination of morphine-midazolam.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026