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

Launched by PIA WINTERMARK · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a potential new treatment for babies with a serious condition called neonatal encephalopathy, which can happen when a baby doesn’t get enough oxygen or blood during birth, leading to brain damage. The study will test a medication called sildenafil, commonly known as Viagra®, to see if it can help repair brain injuries caused by this lack of oxygen. Researchers believe that sildenafil, which is already safely used for other conditions in infants, might also improve brain function in babies suffering from this condition.

To participate in the trial, babies must be between 0 to 2 years old, have been born at least 36 weeks into the pregnancy, and show signs of distress during or after birth. This includes specific medical indicators like low scores on newborn assessments and brain scans showing injury. If eligible, participants will receive sildenafil along with standard care, which includes a treatment called hypothermia (cooling the body), and doctors will monitor their progress closely. This trial could lead to new treatments that improve the quality of life for these vulnerable infants and their families in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Male and female neonates meeting the criteria for induced hypothermia:
• • Gestational age ≥36weeks and birth weight ≥1800g;
• • Evidence of fetal distress, i.e., history of an acute perinatal event, cord pH ≤7.0 or base deficit
• • 16 mEq/L;
• • Evidence of neonatal distress, such as an Apgar score ≤5 at 10 minutes, postnatal blood gas pH obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 mEq/L, or a continued need for ventilation initiated at birth and continued for at least 10 minutes;
• • 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.
• • Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life.
• Exclusion Criteria:
• • Neonates with complex congenital heart disease
• • Neonates with cerebral malformations
• • Neonates with genetic syndrome
• • Neonates with intraventricular and/or intraparenchymal hemorrhage on MRI performed on day 2 of life
• • Moribund infants not expected to survive