A Phase 2/3 interventional study of Dexmedetomidine Injectable Solution and Glucose 5% Injectable Solution in Invasive Ventilation, Infant Pain and Infant Discomfort, sponsored by Centre Hospitalier Intercommunal Creteil. Not yet recruiting at 12 sites in France. Open to participants aged Up to 10 Weeks. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Centre Hospitalier Intercommunal Creteil · Phase 2/3, Interventional, and Treatment
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay. Invasive ventilation is a unanimous source of discomfort and pain.
As opposed to the adult and pediatric population, routine use of opioids or midazolam is not recommended in ventilated neonates.
Although opioids are the most frequently prescribed analgosedative drugs in ventilated premature neonates, their use is controversial because of the risk of respiratory depression - which can prolong invasive ventilation- and concerns on long-term neurodevelopment.
Dexmedetomidine, a selective alpha-2- adrenergic agonist routinely used in the adult ICU (intensive care unit), provides light sedation and some analgesia with no or little respiratory-depression effect. It also has neuroprotective properties after pediatric cardiac surgery and in neonatal animal models. Dexmedetomidine is thus a promising candidate drug in ventilated premature neonates that might reduce the duration of mechanical ventilation and preserve neurodevelopment in this vulnerable population.
The investigators hypothesize that the use of dexmedetomidine in ventilated premature neonates could decrease the need for opioids, facilitate extubation and thereby preserve long-term neurodevelopmental outcome.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 246 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Above mentioned age limits (0 -10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks).
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dexmedetomidine Injectable Solution
Drug: Glucose 5% Injectable Solution
Intravenous administration for maximum 20 days
Intravenous administration for maximum 20 days
Dose of Opioids used
Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last.
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Percentage of time (hours) spent within an excessive/appropriate/ insufficient comfort/analgesia state based on the COMFORTneo scale
Scores of COMFORTneo scale : * excessive: score \<11 * appropriate: score between 11 to 13 * insufficient : score \>13
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Duration of invasive ventilation in hours
Time frame: From inclusion to first planned extubation or unplanned extubation lasting at least 24 hours
Number of days with opioids and/or benzodiazepines
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Cumulative dose of midazolam or other benzodiazepines
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of days with paracetamol use
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Frequency of muscle blocker use to improve ventilation
Number of patients receiving muscle bocker
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Rate of extubation failure
Number of reintubation within 7 days after the first planned extubation
Time frame: Within 7 days after the first planned extubation
Rate of unplanned extubation
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Age at full enteral feeding in postmenstrual age (weeks)
To respond to the secondary objective : frequency of opioid-related adverse effects
Time frame: From inclusion to hospital discharge, assessed up to 24 weeks
Frequency of urinary retention episodes
To respond to the secondary objective : frequency of opioid-related adverse effects
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Finnegan neonatal withdrawal scale or any other validated withdrawal scale
To respond to the secondary objective : frequency of opioid-related adverse effects
Time frame: Within 7 days of the first planned extubation or unplanned extubation lasting at least 24 hours
Number of Bradycardia episodes
Heart rate \< 100/min for 5 consecutive minutes
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of hypotension episodes
Mean arterial blood pressure in mmHg \< postmenstrual age in weeks.
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Frequency of anti-hypotensive treatments use
Volume expansion (at least 10 ml/kg), dopamine, dobutamine, epinephrine, norepinephrine, milrinone or hydrocortisone for hemodynamic support.
Time frame: From the start of the investigational drug to the cessation of any opioid or of the investigational drug for at least 24 hours, whichever comes last
Number of In-hospital deaths
Time frame: At 36 weeks postmenstrual age
Number of In-hospital deaths
Time frame: From the inclusion to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of invasive ventilation
Number of days
Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of non-invasive ventilation
Number of days
Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration of NICU stays
Number of days
Time frame: From the start of the investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Total duration Hospital stay
Number of days
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting high-grade intraventricular hemorrhage Grade 3 and 4
To respond secondary objective of neonatal morbidities
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting periventricular leukomalacia
To respond secondary objective of severe neonatal morbidities
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting secondary sepsis
To respond secondary objective of severe neonatal morbidities
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patientsTreated for patent ductus arteriosus
To respond secondary objective of severe neonatal morbidities
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting bronchopulmonary dysplasia
To respond secondary objective of severe neonatal morbidities
Time frame: At 36 weeks postmenstrual age
Number of patients presenting necrotizing enterocolitis
To respond secondary objective of severe neonatal morbidities
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting isolated intestinal perforation
To respond secondary objective of severe neonatal morbidities
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Number of patients presenting treated retinopathy of prematurity
To respond secondary objective of severe neonatal morbidities
Time frame: From the start of investigational drug to hospital discharge or death, whichever comes first, assessed up to 24 weeks
Long-term neurodevelopment using tests validated in French : Parent Report of Children's Abilities-Revised (PARCA-R)
Higher scores indicate improved neurodevelopment
Time frame: At 2 years corrected age +/- 2 months
Long-term neurodevelopment using tests validated in French : BMT-i (Batterie Modulable de Tests informatisée, or "computerized Adaptable Test Battery")
Higher scores indicate improved neurodevelopment
Time frame: At age 6 years +/- 2 months
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
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