Preterm Birth — Effectiveness of Positioning in Preterm Neonates
Citation(s)
Bernhardt I, Marbacher M, Hilfiker R, Radlinger L Inter- and intra-observer agreement of Prechtl's method on the qualitative assessment of general movements in preterm, term and young infants. Early Hum Dev. 2011 Sep;87(9):633-9. doi: 10.1016/j.earlhumdev.2011.04.017. Epub 2011 May 26.
Madlinger-Lewis L, Reynolds L, Zarem C, Crapnell T, Inder T, Pineda R The effects of alternative positioning on preterm infants in the neonatal intensive care unit: a randomized clinical trial. Res Dev Disabil. 2014 Feb;35(2):490-7. doi: 10.1016/j.ridd.2013.11.019. Epub 2013 Dec 25. Erratum In: Res Dev Disabil. 2015 Jun-Jul;41-42:101-2.
Toso BR, Viera CS, Valter JM, Delatore S, Barreto GM Validation of newborn positioning protocol in Intensive Care Unit. Rev Bras Enferm. 2015 Nov-Dec;68(6):1147-53. doi: 10.1590/0034-7167.2015680621i. English, Portuguese.
Yeh KK, Liu WY, Wong AM, Chung CY, Lien R, Chuang YF Intra-observer reliability of Prechtl's method for the qualitative assessment of general movements in Taiwanese infants. J Phys Ther Sci. 2016 May;28(5):1588-94. doi: 10.1589/jpts.28.1588. Epub 2016 May 31.
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.
