NCT03550612 - 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)

Bednarek N, Mathur A, Inder T, Wilkinson J, Neil J, Shimony J
Impact of therapeutic hypothermia on MRI diffusion changes in neonatal encephalopathy. Neurology. 2012 May 1;78(18):1420-7. doi: 10.1212/WNL.0b013e318253d589. Epub 2012 Apr 18.
Campbell O, Gipson R, el-Mohandes A, Issa AH, Matta N, Mansour E, Mohsen L
The Egypt National Perinatal/Neonatal Mortality Study 2000. J Perinatol. 2004 May;24(5):284-9.
El-Tallawy HN, Farghaly WM, Shehata GA, Metwally NA, Rageh TA, Abo-Elfetoh N
Epidemiology of cerebral palsy in El-Kharga District-New Valley (Egypt). Brain Dev. 2011 May;33(5):406-11. doi: 10.1016/j.braindev.2010.07.011. Epub 2010 Aug 24.
Forman KR, Diab Y, Wong EC, Baumgart S, Luban NL, Massaro AN
Coagulopathy in newborns with hypoxic ischemic encephalopathy (HIE) treated with therapeutic hypothermia: a retrospective case-control study. BMC Pediatr. 2014 Nov 3;14:277. doi: 10.1186/1471-2431-14-277.
Merchant N, Azzopardi D
Early predictors of outcome in infants treated with hypothermia for hypoxic-ischaemic encephalopathy. Dev Med Child Neurol. 2015 Apr;57 Suppl 3:8-16. doi: 10.1111/dmcn.12726. Review.
Pierrat V, Haouari N, Liska A, Thomas D, Subtil D, Truffert P; Groupe d'Etudes en Epidémiologie Périnatale
Prevalence, causes, and outcome at 2 years of age of newborn encephalopathy: population based study. Arch Dis Child Fetal Neonatal Ed. 2005 May;90(3):F257-61.
Tao JD, Mathur AM
Using amplitude-integrated EEG in neonatal intensive care. J Perinatol. 2010 Oct;30 Suppl:S73-81. doi: 10.1038/jp.2010.93. Review.

Neonatal Hypoxic Ischemic Encephalopathy:Targeting Early Diagnosis and Management of Associated Comorbidities

Details for clinical trial NCT03550612

Clinical trial NCT03550612 - References