NCT00552383 - 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)

Als H, Lawhon G, Brown E, Gibes R, Duffy FH, McAnulty G, Blickman JG
Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: neonatal intensive care unit and developmental outcome. Pediatrics. 1986 Dec;78(6):1123-32.
Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG
Individualized developmental care for the very low-birth-weight preterm infant. Medical and neurofunctional effects. JAMA. 1994 Sep 21;272(11):853-8.
Fleisher BE, VandenBerg K, Constantinou J, Heller C, Benitz WE, Johnson A, Rosenthal A, Stevenson DK
Individualized developmental care for very-low-birth-weight premature infants. Clin Pediatr (Phila). 1995 Oct;34(10):523-9. Erratum in: Clin Pediatr (Phila) 1996 Mar;35(3):172.
Westrup B, Kleberg A, von Eichwald K, Stjernqvist K, Lagercrantz H
A randomized, controlled trial to evaluate the effects of the newborn individualized developmental care and assessment program in a Swedish setting. Pediatrics. 2000 Jan;105(1 Pt 1):66-72.

The Impact of Developmental Care in the Neonatal Intensive Care Unit: The Edmonton Randomised Controlled Trial of NIDCAP (Newborn Individualised Developmental Care and Assessment Program)

Details for clinical trial NCT00552383

Clinical trial NCT00552383 - References