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 range6 Hours

SexALL

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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)

What they're measuring

Percentage of time spent in the desired pCO2 range of 40-60 mmHg (temp. corrected) during CO2 inhalation.

Timeframe: 3 days

Trial details

NCT IDNCT02700854

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09

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