NCT04050384 - 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)

Grunau RE, Oberlander T, Holsti L, Whitfield MF
Bedside application of the Neonatal Facial Coding System in pain assessment of premature neonates. Pain. 1998 Jun;76(3):277-286. doi: 10.1016/S0304-3959(98)00046-3.
Maitre NL, Stark AR, McCoy Menser CC, Chorna OD, France DJ, Key AF, Wilkens K, Moore-Clingenpeel M, Wilkes DM, Bruehl S
Cry presence and amplitude do not reflect cortical processing of painful stimuli in newborns with distinct responses to touch or cold. Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F428-F433. doi: 10.1136/archdischild-2016-312279. Epub 2017 May 12.
Relland LM, Gehred A, Maitre NL
Behavioral and Physiological Signs for Pain Assessment in Preterm and Term Neonates During a Nociception-Specific Response: A Systematic Review. Pediatr Neurol. 2019 Jan;90:13-23. doi: 10.1016/j.pediatrneurol.2018.10.001. Epub 2018 Oct 10.

Effect of a Vibratory Stimulus on the Mitigation of Nociception-specific Behavioral and Electroencephalographic Responses to Skin Puncture in Neonates: a Randomized Control Trial

Details for clinical trial NCT04050384

Clinical trial NCT04050384 - References