I have wondered this so many times re giving a placebo. I guess...

I have wondered this so many times re giving a placebo. I guess there is no proof yet that it would save the kids life.

That being said, the safety profile works in our favour for a Placebo only trial and as you said, we could arguably compare against existing cooling therapy data if its deemed unethical to compare against a Placebo.

Interesting point about testing the brain damage - you would imagine that there would be milestones and markers that would manifest quite quickly within the first 6 months - feeding came to mind.

I did a quick google and there seems to be a range of measures that could tell whether the drug was having a positive impact that are both qualitative and quantitative:

Signs and Symptoms:

• Breathing problems: Difficulty breathing, pauses in breathing (apnea), or abnormal breathing patterns.
• Abnormal movements: Seizures, unusual or jerky movements, or tremors.
• Low muscle tone: Floppy or limp body, or difficulty with movement.
• Decreased alertness: Drowsiness, difficulty waking, or reduced responsiveness to stimuli.
• Feeding problems: Difficulty sucking, swallowing, or coordinating breathing while feeding.
• Skin discoloration: Pale, blue, or gray skin or lips.
• Other symptoms: Weak cry, irritability, poor reflexes, or slow heart rate.

Diagnosis and Evaluation:

• Medical evaluation: Doctors will assess the baby's vital signs, reflexes, and overall health.
• Blood tests: These can help identify signs of acidosis or other organ damage.
• Brain imaging: MRI and EEG can help visualize the extent of brain damage.
• Monitoring: Vital signs, brain activity, and other parameters may be monitored for a period of time.

Super interesting to see how they tackle this.

As KJK points out, there is another aspect to this trial that is relevant - TBI and Stroke. You would hope that when this trial is designed, it takes into consideration any factors related to those other conditions (where possible) so we can demonstrate efficacy easily, if ever needed.