Bhutani VK, Johnson L, Sivieri EM Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics. 1999 Jan;103(1):6-14.
Bhutani, V K., Screening for severe neonatal hyperbilirubinemia. Pediatric Health, 2009. 3(4): p. 369-379.
Ceriani, R J., Ferreira C. P. , M. A., Effect of Timing of Cord Clamping on Postnatal Hematocrit Values and Clinical Outcome in Term Infants. A Randomized, Controlled Trial. Pediatr Res, 2005. 57(6): p. 922-922.
Gupta R, Ramji S Effect of delayed cord clamping on iron stores in infants born to anemic mothers: a randomized controlled trial. Indian Pediatr. 2002 Feb;39(2):130-5.
Keren R, Tremont K, Luan X, Cnaan A Visual assessment of jaundice in term and late preterm infants. Arch Dis Child Fetal Neonatal Ed. 2009 Sep;94(5):F317-22. doi: 10.1136/adc.2008.150714. Epub 2009 Mar 22.
McDonald SJ, Middleton P Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. doi: 10.1002/14651858.CD004074.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;7:CD004074.
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.
