NCT02948491 - 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)

Amini E, Rafiei P, Zarei K, Gohari M, Hamidi M
Effect of lullaby and classical music on physiologic stability of hospitalized preterm infants: a randomized trial. J Neonatal Perinatal Med. 2013 Jan 1;6(4):295-301. doi: 10.3233/NPM-1371313.
Auto FM, Amancio OM, Lanza FC
The effect of music on weight gain of preterm infants older than 32 weeks: a randomized clinical trial. Revista Paulista de Pediatria 33(4): e293-e299, 2015.
Diggle P, Heagerty P, Liang KY, Zeger S
Analysis of Longitudinal Data. Second edition. Oxford, UK: Oxford University Press, 2013.
Lai HL, Chen CJ, Peng TC, Chang FM, Hsieh ML, Huang HY, Chang SC
Randomized controlled trial of music during kangaroo care on maternal state anxiety and preterm infants' responses. Int J Nurs Stud. 2006 Feb;43(2):139-46. Epub 2005 Jul 5.
Loewy J
NICU music therapy: song of kin as critical lullaby in research and practice. Ann N Y Acad Sci. 2015 Mar;1337:178-85. doi: 10.1111/nyas.12648.
Macpherson H
Pragmatic clinical trials. Complement Ther Med. 2004 Jun-Sep;12(2-3):136-40.
Patsopoulos NA
A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217-24. Review.
Standley J
Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311. Review.
Standley JM, Cassidy J, Grant R, Cevasco A, Szuch C, Nguyen J, Walworth D, Procelli D, Jarred J, Adams K
The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants. Pediatr Nurs. 2010 May-Jun;36(3):138-45.
Whitelaw A
Core Concepts: Intraventricular Hemorrhage NeoReviews 12 (2): e94-e10, 2011

Effectiveness of Music Therapy on the Intra-hospital Evolution and Neurodevelopment of Preterm Neonates Treated in Neonatal Intensive Care Units in the Bucaramanga Metropolitan Area

Details for clinical trial NCT02948491

Clinical trial NCT02948491 - References