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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within first 10 days of life

Awards & highlights

SANE-02 Trial 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.Check my eligibility

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.See study design

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.

SANE-02 Trial 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.

SANE-02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within first 10 days of life

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Death

Hypotension

Secondary outcome measures

Peak Plasma Concentration (Cmax)

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297

14%

Diarrhoea

14%

Oedema peripheral

14%

Headache

10%

Vertigo

10%

Bronchitis

10%

Flushing

10%

Palpitations

10%

Nasopharyngitis

Respiratory tract infection

Pulmonary hypertension

Depression

Presyncope

Dyspnoea

Right ventricular failure

Vision blurred

Pulmonary arterial hypertension

Upper respiratory tract infection

Bronchopneumonia

Anaemia

Hypertension

Cough

Acute coronary syndrome

Inguinal hernia

Asthenia

Cardiovascular disorder

Mitral valve incompetence

Gangrene

Respiratory syncytial virus infection

Urinary tract infection

Walking distance test abnormal

Breast cancer

Uterine haemorrhage

Haemoptysis

Hypoxia

Skin ulcer

Nausea

Back pain

Death

General physical health deterioration

Circulatory collapse

Cardiac failure

Coronary artery disease

Chest discomfort

Pancreatic neoplasm

Haemoglobin decreased

Sinusitis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sildenafil

SANE-02 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

444 Previous Clinical Trials

159,528 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any spots remaining in this clinical trial?

"According to the clinicaltrials.gov listing, this trial is not actively enrolling patients at present. After being posted on September 19th 2019 and last updated on February 7th 2022, there are currently no recruitment efforts underway for this study; however, 346 other trials require participants right now."

Answered by AI

What medical conditions benefit from the administration of Sildenafil Citrate?

"Sildenafil Citrate has been indicated to be a valid treatment for premature ejaculation, as well any NYHA Functional Class II and III cases of pulmonary arterial hypertension."

Answered by AI

How many participants are involved in this clinical research effort?

"Recruitment for this medical research has ended. The initial posting date was September 19th 2019 and it was last edited on February 7th 2022. For those seeking alternative clinical trials, there are currently 323 active studies about asphyxia and 23 looking at the effects of Sildenafil Citrate with open enrollment."

Answered by AI

What characteristics make an individual suitable for participating in this medical trial?

"Twenty infants aged between 0 days and 2 days afflicted with asphyxia are being admitted to this trial, who must also fulfil the qualifying criteria of neonatal distress (e.g. Apgar score ≤ 5 at 10 minutes, postnatal blood gas pH ≤ 7.0 or base deficit≤ -16 mEq/L) and a persistent need for ventilation initiated at birth sustained for over 10 minutes)."

Answered by AI

Is Sildenafil Citrate a safe option for patients?

"As this trial is at the Phase 1 stage, there are only minimal data to corroborate both safety and efficacy. Thus, we rate Sildenafil Citrate's safety as a low score of 1 on our scale."

Answered by AI

Is this experiment accessible to those aged eighty and above?

"The parameters for enrollment in this clinical trial are restricted to patients aged 0 Days to 2 Days. There are 79 studies designed for minors and 244 specifically catered towards senior citizens."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia

Pia Wintermark 2019. "Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04169191.

All > Brain Injury