Trial · NCT04016246
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | need for mechanical ventilation after the procedure | 72hours | Rate of mechanical ventilation from the start of the LISA procedure up to 72 hours of life Pain before procedure (need of ketamine administration) or within 1 hour following first injection of propofol/placebo (FANS score ≥ 6) |
| Secondary | Rate of MV (mechanical ventilation ) in each class of GA (<28, 28-31wGA) | 72hours | Rate of MV (mechanical ventilation ) from the start of the LISA procedure up to 72 hours of life in each class of GA (\<28, 28-31wGA) |
| Secondary | FANS during LISA and 1h after LISA | 1hour | Faceless acute neonatal pain scale (FANS) assessed during LISA and 1 hour after the procedure by an independent operator. |
| Secondary | number of ketamine administrations for rescue | before LISA Procedure | Number of ketamine administrations for rescue in order to obtain a FANS score \<6 and to be able to proceed to LISA. |
| Secondary | Number of laryngoscopies | during LISA Procedure (T0) | Number of laryngoscopies needed to perform LISA |
| Secondary | Tolerance and efficacy (Per procedure events): Apnea | during LISA Procedure (T0) | Apnea requiring bag mask ventilation |
| Secondary | Tolerance and efficacy (Per procedure events): emergency intubation | from drug injection to 1hour after | Emergency intubation after the drug injection before the LISA procedure can be performed or within 1h following the drug injection |
| Secondary | Tolerance and efficacy (Per procedure events): Viby Mogensen score | during LISA Procedure | Clinician's satisfaction during laryngoscopy with the Viby Mogensen score : Item Score 1 Score 2 Score 3 Score 4 Laryngoscopy Easy Fair Difficult Impossible Vocal cords Open Moving Closing Closed Coughing None Slight Moderate Severe Jaw relaxation Complete Slight Stiff Rigid Limb movements None Slight Moderate Severe the total score is calculated adding each item scores. min score = 5. max score = 20. An easy intubation would obtain a low score and a difficult intubation would have a high score. |
| Secondary | BPD (bronchopulmonary dysplasia) at 36 weeks of Gestational Age | equivalent to 36 weeks of Gestational Age | Broncho Pulmonary Dysplasia at 36 weeks of Gestational Age |
| Secondary | In-hospital morbidity and mortality: pneumothorax | 72hours post LISA Procedure | Pneumothorax within 72hours |
| Secondary | In-hospital morbidity and mortality: Necrotizing Enterocolitis | the day of discharge from hospital (the day depends to each participant : between 36-45 weeks of Gestational Age) | necrotizing enterocolitis during hospitalization |
| Secondary | In-hospital morbidity and mortality : sepsis | the day of discharge from hospital (the day depends to each participant : between 36-45 weeks of Gestational Age) | proven sepsis during hospitalization |
| Secondary | In-hospital morbidity and mortality: retinopathy | the day of discharge from hospital (the day depends to each participant : between 36-45weeks of gestational ageGA) | retinopathy of prematurity during hospitalization |
| Secondary | In-hospital morbidity and mortality | the day of discharge from hospital (the day depends to each participant : between 36-45weeks of Gestational Age) | periventricular leukomalacia or grade 3 or 4 intraventricular hemorrhage during hospitalization |
| Secondary | In-hospital morbidity and mortality: patent ductus arteriosus | the day of discharge from hospital (the day depends to each participant : between 36-45 weeks of Gestational Age) | treatment of a patent ductus arteriosus during hospitalization |
| Secondary | In-hospital morbidity and mortality: death 36weeks of Gestational Age | equivalent to 36 weeks of Gestational Age | Death at 36 weeks of Gestational Age |
| Secondary | In-hospital morbidity and mortality: death during hospitalization | the day of discharge from hospital (the day depends to each participant : between 36-45weeks of Gestational Age) | in-hospital mortality |
| Secondary | At two years of corrected age: ASQ (Ages and Stages Questionnaire) | 2 years (corrected age) | ASQ (Ages and Stages Questionnaire) questionnaire is a general developmental screening tool (5 areas are evaluated: Communication, gross motor, fine motor, problem solving, and personal-social). Total score is the sum of each of the 5 area scores (wich are between 0-60. Total score is between 0 and 300. The higher the score is, the best developed the children is. |
| Secondary | At two years of corrected age: motor function | 2 years (corrected age) | Gross Motor Function Classification Scale (GMFCS) looks at movements such as sitting, walking and use of mobility devices. It is helpful because it provides families and clinicians with a clear description of a child's current motor function, and an idea of what equipment or mobility aids a child may need in the future, e.g. crutches, walking frames or wheelchairs. Participant will be assignated to one of the 5 levels by the clinicians : a patient who is in level 5 has more motor impairments than a patient in level 1. |
| Secondary | At two years of corrected age: vision | 2 years (corrected age) | Visual functions : a clinical examination will conclude if the participant has a visual deficit or not. And in the deficit case, what kind of vision pathology. |
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.
For software
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