Intranasal Midazolam versus intranasal Ketamine to sedate newborns for intubation in delivery room

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003216-23-FR

Enrollment

120

Registered

2011-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2018-03-05

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

Conditions

Maladie des membranes hyalines du nouveau-né (Code CIM : P22.OX-001)

Interventions

Trade Name: KETAMINE Product Name: KETAMINE Pharmaceutical Form: Injection Trade Name: MIDAZOLAM Product Name: MIDAZOLAM Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) neonates in delivery room (2) Presence of repiratory distress syndrom requiring intubation (Silverman score> 3 and / or FiO2 greater than 30 % in premature infants under 30 weeks and over 40% after 30 weeks (3) hemodynamic stability (mean arterial pressure> 3° percentile) Are the trial subjects under 18? yes Number of subjects for this age range: 120 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: (1) Need for intubation in extreme emergency (pneumothorax, meconium aspiration, congenital diaphragmatic hernia, perinatal asphyxia) (2) Birth in the absence of an independent appraiser (3) mother under general anesthesia

Design outcomes

Primary

Measure	Time frame
Primary end point(s): -The clinical pain score will be evaluated on film a posteriori by two independent observers using a scale of hetero pain assessment. ;Main Objective: To compare newborns sedation quality as they are sedated either by intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.;Secondary Objective: To compare intubation quality, hemodynamic and respiratory tolerance, and neurological outcomeat 2 years within the two groups.	—

Measure

Time frame

Primary end point(s): -The clinical pain score will be evaluated on film a posteriori by two independent observers using a scale of hetero pain assessment. ;Main Objective: To compare newborns sedation quality as they are sedated either by intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.;Secondary Objective: To compare intubation quality, hemodynamic and respiratory tolerance, and neurological outcomeat 2 years within the two groups.

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Secondary

Measure	Time frame
Secondary end point(s): -The quality of intubation will be judged by the number of attempts required and by the duration of glottis exposure. -Pain will be evaluated through the study of skin conductance. -Hemodynamic and respiratory tolerances will be judged by measuring respectively variations in blood pressure, heart rate, FiO2 and the oxygen saturation. The neurological follow-up will be carried out according to Brunet-Lezine developmental scale at the age of 2 years.	—

Measure

Time frame

Secondary end point(s): -The quality of intubation will be judged by the number of attempts required and by the duration of glottis exposure. -Pain will be evaluated through the study of skin conductance. -Hemodynamic and respiratory tolerances will be judged by measuring respectively variations in blood pressure, heart rate, FiO2 and the oxygen saturation. The neurological follow-up will be carried out according to Brunet-Lezine developmental scale at the age of 2 years.

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Countries

France

Outcome results

None listed

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