Trial · NCT06878703
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time, measured in minutes, is evaluated from the discontinuation of the experimental treatment (either dexmedetomidine-based or midazolam-based sedation) to extubation. | from the discontinuation of the experimental treatment to extubation (48 maximum) | to compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates. |
| Secondary | Administration of Opioid Agents During Sedation with Dexmedetomidine or Midazolam in Neonatal Intensive Care. | from the start of treatment (dexmedetomidine or midazolam) until extubation (16 days maximum) | Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation (total cumulative dose and morphine equivalents in mg/kg, duration). opioids include morphine (1), fentanyl (0.010), remifentanil (0.15), sufentanil (0.003) and methadone (0.3). |
| Secondary | Quality of sedation | Before sedation, then every 30 min after sedation initiation, then every 3 hours after the initial 60 min, and up to 14 days | Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17), |
| Secondary | Extubation failure 24 hours after extubation | In 24 hours after extubation | Intubation proportion at 24 hours after extubation. |
| Secondary | Withdrawal syndrome (Finnegan score >8). | 6 hours, within 7 days after extubation. | Proportion of patients with at least one value of the Finnegan score \> 8 from within 3 days after extubation. |
| Secondary | Hemodynamic and respiratory adverse effects between inclusion and 84 hours after treatment discontinuation, | From start of the sedation until 84 h after the sedative is stopped (maximum 18 days) | * Bradycardia defined by heart rate \< 80 bpm considered as clinically significant by the treating physician, despite optimization of hemodynamic management * Hemodynamic instability defined by a mean blood pressure below corrected GA, or a skin recoloration time \> 3 seconds despite optimization of haemodynamic management * Desaturation \<85% despite optimization of mechanical ventilation * Reintubation |
| Secondary | In hospital morbi mortality. | the period of hospitalization and within the limit of 24 months | Severe neonatal morbidity as : * late onset sepsis defined by a positive blood culture and antibiotic therapy more than 72 hours, * necrotizing enterocolitis according to Bell's definition61 * moderate (fraction of inspired oxygen (FiO2) \<30%) and severe (FiO2 ≥30%) bronchopulmonary dysplasia at 36 WG defined by need of IMV, nasal continuous positive airway pressure, or nasal cannula at 36 weeks postmenstrual age, according to Jobe's definition * retinopathy of prematurity is diagnosed at the fundus performed systematically before discharge, intraventricular hemorrhage diagnosed on routine transfontanelar ultrasound, according to Papile classification |
| Other | Exploratory outcome: Duration (in hours) of invasive mechanical ventilation from intubation to extubation | From intubation to extubation | To assess the impact of the treatment on Duration of mechanical ventilation |
| Other | Exploratory outcome: Length of stay in the NICU | Within the limit of 24 months | |
| Other | Exploratory outcome: : Short-term clinical outcomes | at 36 Week of Gestation | Survival without moderate and severe bronchopulmonary dysplasia at 36 WG, |
| Other | Exploratory outcome: 2 years neurodevelopment | At 2 years | Neurodevelopment at 2 years assessed by the Score of Ages \& Stages (ASQ) at 2 years. Score of Age and Stages (ASQ) Questionnaire composed of five fields (communication, gross motor skills, fine motor skills, problem solving and individuals or social skills) ; for each field : Minimum value is 0 Maximum value is 60 An Higher score means better outcome |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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