NCT01270581 - 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)

Dani C, Pratesi S, Migliori C, Bertini G
High flow nasal cannula therapy as respiratory support in the preterm infant. Pediatr Pulmonol. 2009 Jul;44(7):629-34. doi: 10.1002/ppul.21051. Review.
Jasin LR, Kern S, Thompson S, Walter C, Rone JM, Yohannan MD
Subcutaneous scalp emphysema, pneumo-orbitis and pneumocephalus in a neonate on high humidity high flow nasal cannula. J Perinatol. 2008 Nov;28(11):779-81. doi: 10.1038/jp.2008.99.
Lampland AL, Plumm B, Meyers PA, Worwa CT, Mammel MC
Observational study of humidified high-flow nasal cannula compared with nasal continuous positive airway pressure. J Pediatr. 2009 Feb;154(2):177-82. doi: 10.1016/j.jpeds.2008.07.021. Epub 2008 Aug 30.
Locke RG, Wolfson MR, Shaffer TH, Rubenstein SD, Greenspan JS
Inadvertent administration of positive end-distending pressure during nasal cannula flow. Pediatrics. 1993 Jan;91(1):135-8.
Shoemaker MT, Pierce MR, Yoder BA, DiGeronimo RJ
High flow nasal cannula versus nasal CPAP for neonatal respiratory disease: a retrospective study. J Perinatol. 2007 Feb;27(2):85-91.
Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H
High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3.

High Flow Nasal Cannula vs Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation

Clinical trial NCT01270581 - References