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Phosphodiesterase-5 (PDE-5) Inhibitor

Sildenafil for Neonatal Asphyxia (SANE-02 Trial)

Phase 1
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and/or an amplitude-integrated electroencephalogram (aEEG)
Be younger than 18 years old
Must not have
Neonates with genetic syndrome
Neonates with cerebral malformations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within first 10 days of life
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if sildenafil is safe and effective in newborns with brain injuries who are being treated with hypothermia.

Who is the study for?
This trial is for newborns who are at least 36 weeks old, weigh over 1800 grams, and have suffered from birth asphyxia leading to brain injury. They must show signs of distress like low Apgar scores or poor blood gas levels and have evidence of brain injury on an MRI. Babies with complex heart disease, genetic syndromes, or certain types of bleeding in the brain can't participate.
What is being tested?
The study is testing different doses of Sildenafil Citrate up to a maximum of 6 mg/kg/day in newborns with brain injuries from asphyxia despite being cooled (hypothermia treatment). Researchers want to find the highest dose babies can tolerate without serious side effects and see if it helps their brains and hearts.
What are the potential side effects?
While not explicitly listed here, potential side effects may include issues related to blood pressure changes since Sildenafil affects blood vessels. Close monitoring will be done for any adverse reactions affecting the baby's heart or other organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My newborn has signs of severe brain injury confirmed by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My newborn has a genetic syndrome.
Select...
My newborn has brain malformations.
Select...
My newborn had a brain bleed detected by MRI on their second day.
Select...
My newborn has a complex heart condition present from birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within first 10 days of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and within first 10 days of life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Death
Hypotension
Secondary study objectives
Peak Plasma Concentration (Cmax)

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297
14%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Flushing
10%
Bronchitis
10%
Nasopharyngitis
10%
Vertigo
10%
Palpitations
8%
Respiratory tract infection
6%
Depression
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
6%
Presyncope
6%
Pulmonary hypertension
4%
Anaemia
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
2%
Nausea
2%
Cardiac failure
2%
Cough
2%
Acute coronary syndrome
2%
Hypoxia
2%
Cardiovascular disorder
2%
Haemoglobin decreased
2%
Death
2%
Skin ulcer
2%
Back pain
2%
Haemoptysis
2%
Chest discomfort
2%
Walking distance test abnormal
2%
Coronary artery disease
2%
Pancreatic neoplasm
2%
Breast cancer
2%
Uterine haemorrhage
2%
Mitral valve incompetence
2%
Inguinal hernia
2%
Circulatory collapse
2%
General physical health deterioration
2%
Urinary tract infection
2%
Asthenia
2%
Respiratory syncytial virus infection
2%
Gangrene
2%
Sinusitis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SildenafilExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil Citrate
2021
Completed Phase 4
~1590

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
166,941 Total Patients Enrolled
~3 spots leftby Nov 2025
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