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Phosphodiesterase-5 Inhibitor

Sildenafil for Neonatal Encephalopathy

Phase 2

Waitlist Available

Led By Pia Wintermark, MD

Research Sponsored by Pia Wintermark

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). They 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 will be slowly rewarmed using standard protocol

Male and female neonates meeting the criteria for induced hypothermia: Gestational age ≥36 weeks and birth weight ≥1800g

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30 of life, compared to day 2 of life

Awards & highlights

Study Summary

This trial will test if the drug Viagra® can help repair brain damage in babies suffering from asphyxia at birth, and may provide new solutions for improving their future life.

Who is the study for?

This trial is for newborns with a condition called asphyxia, which can lead to brain damage. They must be at least 36 weeks old at birth, weigh over 1800g, show signs of distress during and after birth, require ventilation, and have evidence of moderate to severe brain issues. Babies with complex heart disease, genetic syndromes, brain malformations or significant bleeding in the brain are not eligible.Check my eligibility

What is being tested?

The trial is testing if sildenafil (Viagra®), known for treating high blood pressure in babies' lungs, can also repair brain damage caused by asphyxia at birth. The study will give sildenafil orally to these babies alongside standard treatments like cooling the body and will check if it improves their brains' and hearts'/lungs' functions.See study design

What are the potential side effects?

While the side effects specific to neonates taking sildenafil are still being studied, potential risks may include low blood pressure reactions or other impacts on cardiovascular function due to its primary use for pulmonary hypertension.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn has a severe brain condition and will undergo cooling treatment.

Select...

My newborn is eligible for induced hypothermia treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 of life, compared to day 2 of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30 of life, compared to day 2 of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 of life, compared to day 2 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

Extent of brain injury

Secondary outcome measures

Serious adverse events

Other outcome measures

Ejection fraction (EF) in % (reflecting left ventricular function) and tricuspid annular plane systolic excursion (TAPSE) in cm (reflecting right ventricular function)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SildenafilActive Control1 Intervention

Sildenafil 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 (dose 1=2mg/kg/dose, dose 2=2.5mg/kg/dose, and doses 3-14=3mg/kg/dose)

Group II: Ora-BlendPlacebo Group1 Intervention

Ora-Blend 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 (dose 1=2mg/kg/dose, dose 2=2.5mg/kg/dose, and doses 3-14=3mg/kg/dose)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pia WintermarkLead Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Pia Wintermark, MDPrincipal InvestigatorResearch Institute of the McGill University Health Centre

Frequently Asked Questions

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

Has Sildenafil been sanctioned by the FDA?

"Since Sildenafil is in Phase 2 of clinical trials, our group at Power assigned it a value of two - indicating that there are safety data available but no proven efficacy."

Answered by AI

What criteria must individuals meet in order to partake in this investigation?

"In order to be eligible and admitted into this clinical trial, the individual must have neonatal encephalopathy and their age should range from 0 Minutes up until 48 Hours. The total number of patients accepted is 60."

Answered by AI

Is the research study accommodating geriatric participants?

"This scientific endeavour only welcomes people aged between 0 minutes and 48 hours. There are a total of 130 trials for babies and 335 for adults over the age of 65."

Answered by AI

Are there still openings to take part in this clinical trial?

"As mentioned on clinicaltrials.gov, this medical experiment is not currently recruiting patients. Originally posted on November 1st 2023 and last modified October 23rd 2023, the trial has since ended enrollment; however there are 490 other trials presently in search of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia

Pia Wintermark 2023. "Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06098833.

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