Clinical Trial Details
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NCT02812433 : Sildenafil Administration to Treat Neonatal Encephalopathy
PhasePhase 1
AgesMin: N/A Max: 48 Hours
Inclusion Criteria:

- Male and female asphyxiated newborns meeting the criteria for induced hypothermia:

- Gestational age ? 36 weeks and birth weight ? 1800 g

- Evidence of fetal distress, such as a history of an acute perinatal event, a
cord pH ? 7.0 or base deficit ? - 16 mEq/L

- Evidence of neonatal distress, such as an Apgar score ? 5 at 10 minutes, a
postnatal blood gas pH obtained within the first hour of life ? 7.0 or base
deficit ? - 16 mEq/L, or a continued need for ventilation initiated at birth and
continued for at least 10 minutes

- Evidence of moderate to severe neonatal encephalopathy by an abnormal
neurological exam and/or an amplitude-integrated electroencephalogram (aEEG)
These newborns will receive whole-body cooling to an esophageal temperature of
33.5°C, initiated within the first 6 hours of life, continued for 72 hours, and
then they were slowly rewarmed using standard protocol .

- Evidence on a brain MRI performed on day 2 of life (while they are treated with
hypothermia) of any type of brain parenchymal injury patterns typically encountered
in asphyxiated newborns.

If they meet the criteria for hypothermia treatment and demonstrate brain injury on day 2
of life, they will be randomized to sildenafil or placebo treatment.

Exclusion Criteria:

- Newborns with complex congenital heart disease

- Newborns with cerebral malformations

- Newborns with genetic syndrome

- Newborns with intraventricular and/or intraparenchymal hemorrhage on the MRI
performed on day 2 of life

- Moribund infants not expected to survive
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