NCT03497793 - 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)

1
WHO. Preterm birth. Secondary Preterm birth 2016. http://www.who.int/mediacentre/factsheets/fs363/en/. 2. ONS. Birth Charactersitics. Secondary Birth Charactersitics 2016. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/livebirths/datasets/birthcharacteristicsinenglandandwales. 3. Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev 2016(8):CD002771. 4. Engmann C, Wall S, Darmstadt G, et al. Consensus on kangaroo mother care acceleration. Lancet 2013;382(9907):e26-7. 5. Seidman G, Unnikrishnan S, Kenny E, et al. Barriers and Enablers of Kangaroo Mother Care Practice: A Systematic Review. Plos One 2015;10(5).

A Feasibility Study of the SNUBY®, a Skin-to-skin Garment, in the Preterm Infant

Clinical trial NCT03497793 - References