A Phase 1 interventional study of Sildenafil and Ora-Blend in Neonatal Encephalopathy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 0 Minutes to 48 Hours. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 1, Interventional, and Treatment
Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious condition causing significant mortality and long-term morbidity, including cerebral palsy and mental retardation. Currently, no treatment exists to repair brain injuries secondary to neonatal asphyxia. The only available treatment for this condition is hypothermia that may prevent but not repair the development of brain injury. The success of this therapy is limited.
Sildenafil already is used with some newborns for other purposes (i.e., persistent pulmonary hypertension), but, surprisingly, its effect on the newborn brain has never been studied systematically. The findings of the investigators in the rat model of term neonatal encephalopathy demonstrated that the administration of sildenafil following asphyxia promotes brain injury recovery. Thus, the investigators hypothesize that sildenafil may improve neurodevelopmental outcome in term asphyxiated newborns, in whom hypothermia treatment has failed to prevent the development of brain injury.
Before being able to run a large multicenter randomized trial to prove this hypothesis, the investigators need to run a phase Ib pilot trial to ensure the feasibility and safety of using sildenafil in this population of newborns. Thus, for this phase Ib study, the investigators hypothesize that sildenafil can be safely used with term asphyxiated newborns treated with hypothermia. The investigators will test this hypothesis with the following specific aims:
113 studies on the registry are indexed under Asphyxia Neonatorum; 24 are open to participants now.
This study's enrollment of 28 is below the median of 100 across 85 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.
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Male and female asphyxiated newborns meeting the criteria for induced hypothermia:
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:
Sildenafil 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life
Drug: Sildenafil
Ora-Blend 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life
Drug: Ora-Blend
sildenafil 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life
Ora-Blend, 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life
Serious adverse events
Close monitoring for adverse events such as death, hypotension, persistent pulmonary hypertension, altered renal or hepatic function, etc to assess the safety of sildenafil
Time frame: Day 1 to 14 of life
Plasmatic concentrations of sildenafil and N-desmethyl sildenafil
To determine the tolerability of sildenafil (pharmacokinetics/pharmacodynamics)
Time frame: Day 2 to 10 of life
Brain injury severity as per a previously described brain injury score
Exploratory outcome to explore efficacy (brain injury)
Time frame: Day 30 of life, compared to day 2 of life
panel of 45 inflammatory biomarkers known to be involved in neuroinflammation, including interleukin-1 (IL-1) alpha and its receptor, interleukin-6 (IL-6) and tumor necrosis factor (TNF) alpha
Exploratory outcome to explore efficacy (neuroinflammation)
Time frame: Day 2 to 30 of life
Bayley Scale of Infant Development (BSID-III)
Exploratory outcome to explore efficacy (neurodevelopment)
Time frame: 1 year and 2 years of age
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sildenafil
McGill University Health Centre/Research Institute of the McGill University Health Centre →