Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With … (NCT02700854) | Clinical Trial Compass
CompletedPhase 1
Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2
Hungary10 participantsStarted 2016-02
Plain-language summary
This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is deleterious to the injured brain and can be safely avoided with low concentration CO2 inhalation.
Who can participate
Age range
6 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At any time within six hours of life the temperature corrected pCO2 is less than or equal to 40 mmHg after the parameters of mechanical ventilation is set according to standard protocol (SIMV+VG 5ml/kg, fr 20/min, PEEP 5 H20cm, Ti 0,35-0,45 sec).
* Moderate hypoxic- ischaemic encephalopathy, fulfilling TOBY criteria (A, B, C).
* ≥ 36. gest. week
* \< 6th hours of life
* Hypothermia treatment
* Parental consent form
* Spontaneous breathing
* Endotracheal intubation
* AUC, VUC in place
Exclusion Criteria:
* Major birth defect
* Meconium aspiration syndrome
* Need for combined catecholamine therapy
* FiO2 \> 40%
* Htc \< 35%
* Acid-base status: pH \< 6.8, lactate \> 15mM
* Excessive bicarbonate administration during initial stabilization (\> 1mmol/kg)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 1 trial testing inhaled CO2 to keep carbon dioxide levels in a specific range for babies with HIE — what did the results show about whether that target range was safely achievable, and is there any published data we can review together?
2Since this study focused on controlling CO2 levels during cooling therapy for HIE, how does managing carbon dioxide fit into my baby's current treatment plan, and is hypocapnia something the care team is actively monitoring for?
3Because this was an early-phase safety study that has now completed, does my baby's doctor know of any follow-up or larger trials building on this research that might be relevant to our situation?
4Standard therapeutic hypothermia (cooling) is already an established treatment for HIE — how does the approach tested in this trial compare to what is currently considered the standard of care for my baby?
5Given that this trial measured how well CO2 levels could be controlled during treatment, what are the potential risks of either too much or too little CO2 for a newborn with HIE, and how does my baby's team currently manage that balance?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of time spent in the desired pCO2 range of 40-60 mmHg (temp. corrected) during CO2 inhalation.