NCT03390348 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H
Reliability of the Language ENvironment Analysis system (LENA™) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8.
Dykstra JR, Sabatos-Devito MG, Irvin DW, Boyd BA, Hume KA, Odom SL
Using the Language Environment Analysis (LENA) system in preschool classrooms with children with autism spectrum disorders. Autism. 2013 Sep;17(5):582-94. doi: 10.1177/1362361312446206. Epub 2012 Jul 2.

An In-home Observational Study to Compare Infant Crying and Fussing Parameters Documented by the LENA Recorder With Those Documented Via Parental E-diaries

Details for clinical trial NCT03390348

Clinical trial NCT03390348 - References