Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06098833
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-10-18
Brief Title:
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Sponsor:
Pia Wintermark
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia A Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Around the time of birth some babies experience a condition called asphyxia which means that their brain and other organs do not receive enough blood andor oxygen to work properly This life-threatening condition accounts for nearly 1 out of 4 deaths of all babies around the world and often leads to severe brain damage cerebral palsy epilepsy and trouble with learning and functioning in everyday life At this time no treatment is available to repair the brain damage caused by asphyxia Excitingly a drug called sildenafil Viagra is already given safely to babies who suffer from increased blood pressure in their lungs vessels Recent studies using a laboratory model of asphyxia at birth suggest that sildenafil may also repair the brain damage caused by asphyxia Similarly recent small studies have shown that it is both feasible and safe to give sildenafil to human babies who suffered from asphyxia at birth These studies also highlight the first promising signs that sildenafil may improve how the brains of these babies work which is consistent with the abovementioned laboratory studies
On the basis of these previous researches the investigators predict that sildenafil can repair the damage to a babys brain The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth and will confirm whether sildenafil improves or not how their brains and heartslungs work
This project will enable to determine whether sildenafil is a promising treatment for repairing brain damage in babies who suffer from asphyxia at birth This project may also provide new solutions for these babies to improve their future life
On the basis of these previous researches the investigators predict that sildenafil can repair the damage to a babys brain The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth and will confirm whether sildenafil improves or not how their brains and heartslungs work
This project will enable to determine whether sildenafil is a promising treatment for repairing brain damage in babies who suffer from asphyxia at birth This project may also provide new solutions for these babies to improve their future life
Detailed Description:
The investigators will enroll neonates with HIE treated with TH from NICUs in a multicentre randomized double-blind placebo-controlled phase 2 clinical trial to evaluate the safety and efficacy of sildenafil to repair brain injury Neonates with moderate-severe HIE on admission and with brain injury on a day-2 brain MRI during TH will be randomized to sildenafil or placebo allocation 21 for 7 consecutive days
Aim 1 Evaluate the efficacy of sildenafil to improve brain injury primary outcome The investigators will determine whether sildenafil reduces brain injury on a day-30 MRI compared to the baseline day-2 MRI
Aim 2 Determine the safety of sildenafil secondary outcome The investigators will assess the safety of sildenafil by recording the incidence of adverse events
Aim 3 Evaluate the efficacy of sildenafil to improve cardiopulmonary hemodynamics secondary outcome The investigators will determine whether sildenafil improves pulmonary pressure and rightleft ventricular function on day 4 of life after TH completion compared to baseline day-2 measurements
Aim 1 Evaluate the efficacy of sildenafil to improve brain injury primary outcome The investigators will determine whether sildenafil reduces brain injury on a day-30 MRI compared to the baseline day-2 MRI
Aim 2 Determine the safety of sildenafil secondary outcome The investigators will assess the safety of sildenafil by recording the incidence of adverse events
Aim 3 Evaluate the efficacy of sildenafil to improve cardiopulmonary hemodynamics secondary outcome The investigators will determine whether sildenafil improves pulmonary pressure and rightleft ventricular function on day 4 of life after TH completion compared to baseline day-2 measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None