NCT03303755 - 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)

Abdel-Rahman SM, Ahlers N, Holmes A, Wright K, Harris A, Weigel J, Hill T, Baird K, Michaels M, Kearns GL
Validation of an improved pediatric weight estimation strategy. J Pediatr Pharmacol Ther. 2013 Apr;18(2):112-21. doi: 10.5863/1551-6776-18.2.112.
Bell KL, Davies PS
Prediction of height from knee height in children with cerebral palsy and non-disabled children. Ann Hum Biol. 2006 Jul-Aug;33(4):493-9.
Brooks J, Day S, Shavelle R, Strauss D
Low weight, morbidity, and mortality in children with cerebral palsy: new clinical growth charts. Pediatrics. 2011 Aug;128(2):e299-307. doi: 10.1542/peds.2010-2801. Epub 2011 Jul 18.
Day SM, Strauss DJ, Vachon PJ, Rosenbloom L, Shavelle RM, Wu YW
Growth patterns in a population of children and adolescents with cerebral palsy. Dev Med Child Neurol. 2007 Mar;49(3):167-71.
Kong CK, Wong HS
Weight-for-height values and limb anthropometric composition of tube-fed children with quadriplegic cerebral palsy. Pediatrics. 2005 Dec;116(6):e839-45.
Le Roy O
C, Rebollo G. MJ, Moraga M. F, Díaz Sm. X, Castillo-Durán C. Nutrición del niño con enfermedades neurológicas prevalentes. Rev Chil Pediatr. 2010;81(2):103-113.
Neela J, Raman L, Balakrishna N, Rao KV
Usefulness of calf circumference as a measure for screening low birth weight infants. Indian Pediatr. 1991 Aug;28(8):881-4.
Vega-Sanchez R, de la Luz Gomez-Aguilar M, Haua K, Rozada G
Weight-based nutritional diagnosis of Mexican children and adolescents with neuromotor disabilities. BMC Res Notes. 2012 Jul 4;5:218. doi: 10.1186/1756-0500-5-218.

Elaboration, Development and Validation of Predictive Models of Weight and Height for the Evaluation of the Growth of Children and Adolescents With Cerebral Palsy

Details for clinical trial NCT03303755

Clinical trial NCT03303755 - References