NCT01307293 - 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)

Shaw RJ, St John N, Lilo E, Jo B, Benitz W, Stevenson DK, Horwitz SM
Prevention of traumatic stress in mothers of preterms: 6-month outcomes. Pediatrics. 2014 Aug;134(2):e481-8. doi: 10.1542/peds.2014-0529.
Shaw RJ, St John N, Lilo EA, Jo B, Benitz W, Stevenson DK, Horwitz SM
Prevention of traumatic stress in mothers with preterm infants: a randomized controlled trial. Pediatrics. 2013 Oct;132(4):e886-94. doi: 10.1542/peds.2013-1331. Epub 2013 Sep 2.

Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of Preterm Infants.

Details for clinical trial NCT01307293

Clinical trial NCT01307293 - References