NCT00951860 - Clinical Trial References

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.

Citation(s)

De Rogalski Landrot I, Roche F, Pichot V, Teyssier G, Gaspoz JM, Barthelemy JC, Patural H
Autonomic nervous system activity in premature and full-term infants from theoretical term to 7 years. Auton Neurosci. 2007 Oct 30;136(1-2):105-9. Epub 2007 Jun 7.
Patural H, Pichot V, Jaziri F, Teyssier G, Gaspoz JM, Roche F, Barthelemy JC
Autonomic cardiac control of very preterm newborns: a prolonged dysfunction. Early Hum Dev. 2008 Oct;84(10):681-7. doi: 10.1016/j.earlhumdev.2008.04.010. Epub 2008 Jun 16.
Patural H, Teyssier G, Pichot V, Barthelemy JC
[Normal and changed heart rate maturation of the neonate]. Arch Pediatr. 2008 Jun;15(5):614-6. doi: 10.1016/S0929-693X(08)71851-7. French.

Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort : the AuBE Study

Clinical trial NCT00951860 - References