NCT02825953 - 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)

Berggren E, Liljedahl M, Winbladh B, Andreasson B, Curstedt T, Robertson B, Schollin J
Pilot study of nebulized surfactant therapy for neonatal respiratory distress syndrome. Acta Paediatr. 2000 Apr;89(4):460-4.
Cowan F, Whitelaw A, Wertheim D, Silverman M
Cerebral blood flow velocity changes after rapid administration of surfactant. Arch Dis Child. 1991 Oct;66(10 Spec No):1105-9.
Kero PO, Mäkinen EO
Comparison between clinical and radiological classification of infants with the respiratory distress syndrome (RDS). Eur J Pediatr. 1979 Apr 3;130(4):271-8.
Mercier CE, Soll RF
Clinical trials of natural surfactant extract in respiratory distress syndrome. Clin Perinatol. 1993 Dec;20(4):711-35. Review.
Papile LA, Burstein J, Burstein R, Koffler H
Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34.

Does The Surfactant Administration by Aerosolization of Respiratory Distress Syndrome Effective in Spontaneously Breathing Premature Infants ?

Clinical trial NCT02825953 - References