NCT02311972 - 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)

Almeida PG, Chandley J, Davis J, Harrigan RC
Use of the heated gel mattress and its impact on admission temperature of very low birth-weight infants. Adv Neonatal Care. 2009 Feb;9(1):34-9. doi: 10.1097/01.ANC.0000346094.28110.11.
Basu S, Rathore P, Bhatia BD
Predictors of mortality in very low birth weight neonates in India. Singapore Med J. 2008 Jul;49(7):556-60.
Bhatt DR, White R, Martin G, Van Marter LJ, Finer N, Goldsmith JP, Ramos C, Kukreja S, Ramanathan R
Transitional hypothermia in preterm newborns. J Perinatol. 2007 Dec;27 Suppl 2:S45-7. Review.
Knobel RB, Wimmer JE Jr, Holbert D
Heat loss prevention for preterm infants in the delivery room. J Perinatol. 2005 May;25(5):304-8.
Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network
Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. Epub 2007 Feb 12.
Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ
Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72.
te Pas AB, Lopriore E, Dito I, Morley CJ, Walther FJ
Humidified and heated air during stabilization at birth improves temperature in preterm infants. Pediatrics. 2010 Jun;125(6):e1427-32. doi: 10.1542/peds.2009-2656. Epub 2010 May 10.

Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants

Clinical trial NCT02311972 - References