Dexmedetomidine versus Midazolam to shorten time on the ventilator in very preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial compares continuous intravenous dexmedetomidine infusion versus continuous intravenous midazolam infusion for sedation of very preterm neonates (<32 weeks gestation) who require invasive mechanical ventilation. Infants are randomized to receive a loading dose followed by a maintenance infusion within specified dose ranges for each drug while on ventilation, with care delivered in participating NICUs. The primary outcome centers on time to successful extubation and the protocol aims to enroll about 292 randomized patients (anticipating ~380 screened). Standard inclusion/exclusion and safety monitoring procedures are used to limit enrollment to clinically stable infants without contraindications to either agent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient admitted in NICU (intubated or not yet),
* Gestational age at birth \< 32 weeks of gestation (WG),
* Corrected gestational age \<45 weeks postmenstrual age Written or electronic informed consent signed by both parents.

Randomization Criteria :

* Indication for sedation in the context of invasive mechanical ventilation,
* Patient intubated or not yet,
* Elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),
* Presence or plan of a venous access,
* No medical contraindication related to the administration of dexmedetomidine or midazolam,
* No previous use of dexmedetomidine or midazolam within 48 hours, except for the sedation procedure for intubation,
* No concomitant use of curare agent,
* No clonidine treatment,
* No previous extubation within 7 days,
* No hemodynamic instability
* No palliative care,

Exclusion Criteria:

* Patient admitted in NICU (intubated or not yet),
* Gestational age at birth \< 32 weeks of gestation (WG),
* Corrected gestational age \<45 weeks postmenstrual age Written or electronic informed consent signed by both parents.

Where it's running

• Hospital Armand Trousseau, APHP Service : Department of Neonatology
  Paris, France Recruiting

Study contacts

• Principal investigator: Clément CHOLLAT, Doctor — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Clément CHOLLAT, MD, PhD, Associate Professor
• Email: clement.chollat@aphp.fr
• Phone: +33 6 86 72 29 58

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Heart rate variability and standard tests to help decide when to remove a breathing tube

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.