NCT02731781 - 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)

Beni-Adani L, Flores I, Spektor S, Umansky F, Constantini S
Epidural hematoma in infants: a different entity? J Trauma. 1999 Feb;46(2):306-11.
Hahn YS, Chyung C, Barthel MJ, Bailes J, Flannery AM, McLone DG
Head injuries in children under 36 months of age. Demography and outcome. Childs Nerv Syst. 1988 Feb;4(1):34-40.
Morray JP, Tyler DC, Jones TK, Stuntz JT, Lemire RJ
Coma scale for use in brain-injured children. Crit Care Med. 1984 Dec;12(12):1018-20.
Raimondi AJ, Hirschauer J
Head injury in the infant and toddler. Coma scoring and outcome scale. Childs Brain. 1984;11(1):12-35.
Reilly PL, Simpson DA, Sprod R, Thomas L
Assessing the conscious level in infants and young children: a paediatric version of the Glasgow Coma Scale. Childs Nerv Syst. 1988 Feb;4(1):30-3.
Seshia SS, Seshia MM, Sachdeva RK
Coma in childhood. Dev Med Child Neurol. 1977 Oct;19(5):614-28.
Yi W, Liu R, Chen J, Tao S, Humphrey O, Bergenheim AT
Trauma infant neurologic score predicts the outcome of traumatic brain injury in infants. Pediatr Neurosurg. 2010;46(4):259-66. doi: 10.1159/000321800. Epub 2010 Dec 16.

Trauma Infant Neurological Score (TINS) as a Prognostic Factor and Guideline for CT Scan in Infants 24 Months Old or Less

Clinical trial NCT02731781 - References