Cameron EC, Maehle V, Reid J The effects of an early physical therapy intervention for very preterm, very low birth weight infants: a randomized controlled clinical trial. Pediatr Phys Ther. 2005 Summer;17(2):107-19.
Evensen KA, Skranes J, Brubakk AM, Vik T Predictive value of early motor evaluation in preterm very low birth weight and term small for gestational age children. Early Hum Dev. 2009 Aug;85(8):511-8. doi: 10.1016/j.earlhumdev.2009.04.007. Epub 2009 May 17
Heathcock JC, Lobo M, Galloway JC Movement training advances the emergence of reaching in infants born at less than 33 weeks of gestational age: a randomized clinical trial. Phys Ther. 2008 Mar;88(3):310-22. Epub 2007 Dec 20.
Kodric J, Sustersic B, Paro-Panjan D Assessment of general movements and 2.5 year developmental outcomes: pilot results in a diverse preterm group. Eur J Paediatr Neurol. 2010 Mar;14(2):131-7. doi: 10.1016/j.ejpn.2009.04.012. Epub 2009 Jun 21.
McGowan JE, Alderdice FA, Holmes VA, Johnston L Early childhood development of late-preterm infants: a systematic review. Pediatrics. 2011 Jun;127(6):1111-24. doi: 10.1542/peds.2010-2257. Epub 2011 May 29. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
