Infant, Very Low Birth Weight — Lactation Education Study in Mothers of Very Low Birth Weight Infants
Citation(s)
Furman L, Taylor G, Minich N, Hack M The effect of maternal milk on neonatal morbidity of very low-birth-weight infants. Arch Pediatr Adolesc Med. 2003 Jan;157(1):66-71.
Jones E, Spencer SA Optimising the provision of human milk for preterm infants. Arch Dis Child Fetal Neonatal Ed. 2007 Jul;92(4):F236-8. Review.
Ong J, Miller PS, Appleby R, Allegretto R, Gawlinski A Effect of a preoperative instructional digital video disc on patient knowledge and preparedness for engaging in postoperative care activities. Nurs Clin North Am. 2009 Mar;44(1):103-15, xii. doi: 10.1016/j.cnur.2008.10.014.
Schanler RJ, Hurst NM, Lau C The use of human milk and breastfeeding in premature infants. Clin Perinatol. 1999 Jun;26(2):379-98, vii. Review.
Schanler RJ, Shulman RJ, Lau C Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics. 1999 Jun;103(6 Pt 1):1150-7.
Sisk PM, Lovelady CA, Dillard RG, Gruber KJ, O'Shea TM Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in very low birth weight infants. J Perinatol. 2007 Jul;27(7):428-33. Epub 2007 Apr 19. Erratum in: J Perinatol. 2007 Dec;27(12):808.
Sisk PM, Lovelady CA, Dillard RG, Gruber KJ Lactation counseling for mothers of very low birth weight infants: effect on maternal anxiety and infant intake of human milk. Pediatrics. 2006 Jan;117(1):e67-75.
Sisk PM, Lovelady CA, Gruber KJ, Dillard RG, O'Shea TM Human milk consumption and full enteral feeding among infants who weigh = 1250 grams. Pediatrics. 2008 Jun;121(6):e1528-33. doi: 10.1542/peds.2007-2110. Erratum in: Pediatrics. 2008 Nov;122(5):1162-3.
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.