NCT02781545 - 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)

Brosig CL, Mussatto KA, Kuhn EM, Tweddell JS
Neurodevelopmental outcome in preschool survivors of complex congenital heart disease: implications for clinical practice. J Pediatr Health Care. 2007 Jan-Feb;21(1):3-12.
Donofrio MT, Duplessis AJ, Limperopoulos C
Impact of congenital heart disease on fetal brain development and injury. Curr Opin Pediatr. 2011 Oct;23(5):502-11. doi: 10.1097/MOP.0b013e32834aa583. Review.
Hadders-Algra M
General movements: A window for early identification of children at high risk for developmental disorders. J Pediatr. 2004 Aug;145(2 Suppl):S12-8. Review.
Hadders-Algra M
Variation and variability: key words in human motor development. Phys Ther. 2010 Dec;90(12):1823-37. doi: 10.2522/ptj.20100006. Epub 2010 Oct 21. Review.
Hamer EG, Bos AF, Hadders-Algra M
Assessment of specific characteristics of abnormal general movements: does it enhance the prediction of cerebral palsy? Dev Med Child Neurol. 2011 Aug;53(8):751-6. doi: 10.1111/j.1469-8749.2011.04007.x. Epub 2011 Jun 29.
Hoffman JI, Kaplan S
The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. Review.
Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C
Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45.

Predicting and Monitoring Motor Development of Children Requiring Surgery as Neonates for Complex Congenital Heart Disease

Clinical trial NCT02781545 - References