NCT02543125 - 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)

Colaizy TT, Younis UM, Bell EF, Klein JM
Nasal high-frequency ventilation for premature infants. Acta Paediatr. 2008 Nov;97(11):1518-22. doi: 10.1111/j.1651-2227.2008.00900.x. Epub 2008 Jun 9.
De Luca D, Carnielli VP, Conti G, Piastra M
Noninvasive high frequency oscillatory ventilation through nasal prongs: bench evaluation of efficacy and mechanics. Intensive Care Med. 2010 Dec;36(12):2094-100. doi: 10.1007/s00134-010-2054-7. Epub 2010 Sep 2
Donn SM, Sinha SK
Minimising ventilator induced lung injury in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F226-30. Review.
Fischer HS, Bohlin K, Bührer C, Schmalisch G, Cremer M, Reiss I, Czernik C
Nasal high-frequency oscillation ventilation in neonates: a survey in five European countries. Eur J Pediatr. 2015 Apr;174(4):465-71. doi: 10.1007/s00431-014-2419-y. Epub 2014 Sep
Null DM, Alvord J, Leavitt W, Wint A, Dahl MJ, Presson AP, Lane RH, DiGeronimo RJ, Yoder BA, Albertine KH
High-frequency nasal ventilation for 21 d maintains gas exchange with lower respiratory pressures and promotes alveolarization in preterm lambs. Ped
van der Hoeven M, Brouwer E, Blanco CE
Nasal high frequency ventilation in neonates with moderate respiratory insufficiency. Arch Dis Child Fetal Neonatal Ed. 1998 Jul;79(1):F61-3.

Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation

Clinical trial NCT02543125 - References