NCT05446389 - 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)

Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL
A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17.
Dumpa V, Kamity R, Ferrara L, Akerman M, Hanna N
The effects of oral feeding while on nasal continuous positive airway pressure (NCPAP) in preterm infants. J Perinatol. 2020 Jun;40(6):909-915. doi: 10.1038/s41372-020-0632-2. Epub 2020 Feb 21.
Glackin SJ, O'Sullivan A, George S, Semberova J, Miletin J
High flow nasal cannula versus NCPAP, duration to full oral feeds in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F329-F332. doi: 10.1136/archdischild-2016-311388. Epub 2016 Dec 23.
Hanin M, Nuthakki S, Malkar MB, Jadcherla SR
Safety and Efficacy of Oral Feeding in Infants with BPD on Nasal CPAP. Dysphagia. 2015 Apr;30(2):121-7. doi: 10.1007/s00455-014-9586-x. Epub 2014 Nov 8.
Hatch LD 3rd, Clark RH, Carlo WA, Stark AR, Ely EW, Patrick SW
Changes in Use of Respiratory Support for Preterm Infants in the US, 2008-2018. JAMA Pediatr. 2021 Oct 1;175(10):1017-1024. doi: 10.1001/jamapediatrics.2021.1921.
Jain D, Bancalari E
New Developments in Respiratory Support for Preterm Infants. Am J Perinatol. 2019 Jul;36(S 02):S13-S17. doi: 10.1055/s-0039-1691817. Epub 2019 Jun 25.

The Use of the Pacifier Activated Lullaby to Improve the Transition to Oral Feeding for Premature Infants With Chronic Lung Disease or Respiratory Distress Syndrome

Details for clinical trial NCT05446389

Clinical trial NCT05446389 - References