Respiratory Distress Syndrome, Newborn — Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial
Citation(s)
Chernick V, Avery ME Response of premature infants with periodic breathing to ventilatory stimuli. J Appl Physiol. 1966 Mar;21(2):434-40. doi: 10.1152/jappl.1966.21.2.434. No abstract available.
Dolfin T, Duffty P, Wilkes D, England S, Bryan H Effects of a face mask and pneumotachograph on breathing in sleeping infants. Am Rev Respir Dis. 1983 Dec;128(6):977-9. doi: 10.1164/arrd.1983.128.6.977.
Fleming PJ, Levine MR, Goncalves A Changes in respiratory pattern resulting from the use of a facemask to record respiration in newborn infants. Pediatr Res. 1982 Dec;16(12):1031-4. doi: 10.1203/00006450-198212000-00013.
Murphy MC, McCarthy LK, O'Donnell CPF Crying and breathing by new-born preterm infants after early or delayed cord clamping. Arch Dis Child Fetal Neonatal Ed. 2020 May;105(3):331-333. doi: 10.1136/archdischild-2018-316592. Epub 2019 May 13.
Murphy MC, McCarthy LK, O'Donnell CPF Initiation of respiratory support for extremely preterm infants at birth. Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):208-210. doi: 10.1136/archdischild-2020-319798. Epub 2020 Aug 26.
O'Donnell CP, Kamlin CO, Davis PG, Morley CJ Crying and breathing by extremely preterm infants immediately after birth. J Pediatr. 2010 May;156(5):846-7. doi: 10.1016/j.jpeds.2010.01.007. Epub 2010 Mar 16.
Ramet J, Praud JP, D'Allest AM, Dehan M, Gaultier C Trigeminal airstream stimulation. Maturation-related cardiac and respiratory responses during REM sleep in human infants. Chest. 1990 Jul;98(1):92-6. doi: 10.1378/chest.98.1.92.
Subramaniam P, Ho JJ, Davis PG Prophylactic nasal continuous positive airway pressure for preventing morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2016 Jun 14;(6):CD001243. doi: 10.1002/14651858.CD001243.pub3.
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.
