NCT03730025 - 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)

Binotti M, Cavallin F, Ingrassia PL, Pejovic NJ, Monzani A, Genoni G, Trevisanuto D
Heart rate assessment using NeoTapAdvancedSupport: a simulation study. Arch Dis Child Fetal Neonatal Ed. 2018 Sep 27. pii: fetalneonatal-2018-315408. doi: 10.1136/archdischild-2018-315408. [Epub ahead of print]
Chitkara R, Rajani AK, Oehlert JW, Lee HC, Epi MS, Halamek LP
The accuracy of human senses in the detection of neonatal heart rate during standardized simulated resuscitation: implications for delivery of care, training and technology design. Resuscitation. 2013 Mar;84(3):369-72. doi: 10.1016/j.resuscitation.2012.07.035. Epub 2012 Aug 25.
Murphy MC, De Angelis L, McCarthy LK, O'Donnell CPF
Comparison of infant heart rate assessment by auscultation, ECG and oximetry in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F490-F492. doi: 10.1136/archdischild-2017-314367. Epub 2018 May 25.
Myrnerts Höök S, Pejovic NJ, Marrone G, Tylleskär T, Alfvén T
Accurate and fast neonatal heart rate assessment with a smartphone-based application - a manikin study. Acta Paediatr. 2018 Mar 31. doi: 10.1111/apa.14350. [Epub ahead of print]
Wyllie J, Bruinenberg J, Roehr CC, Rüdiger M, Trevisanuto D, Urlesberger B
European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15.

Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study

Clinical trial NCT03730025 - References