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Phosphodiesterase-5 Inhibitor

Sildenafil for Neonatal Encephalopathy

Phase 2

Recruiting

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

Must not have

Neonates with cerebral malformations

Neonates with intraventricular and/or intraparenchymal hemorrhage on MRI performed on day 2 of life

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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

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

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My newborn is eligible for induced hypothermia treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My newborn has a brain malformation.

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My newborn had a brain bleed detected by MRI on their second day.

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My newborn has a complex heart condition present from birth.

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My newborn has a genetic syndrome.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Extent of brain injury

Secondary study objectives

Serious adverse events

Other study objectives

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 / 6Eligibility criteria met