Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2 (HENRIC)
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|ClinicalTrials.gov Identifier: NCT02700854|
Recruitment Status : Unknown
Verified March 2017 by Ágnes Jermendy, Semmelweis University.
Recruitment status was: Recruiting
First Posted : March 7, 2016
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypoxic-Ischaemic Encephalopathy Perinatal Asphyxia Hypocapnia||Other: 5% carbon-dioxide inhalation||Phase 1|
- To test the feasibility of low concentration inhalative CO2 gas mixture (5% CO2 + 95% air) administration to achieve a desired range of pCO2 of 40-60 mmHg in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy.
- To test the safety of CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with moderate to severe hypoxic-ischemic encephalopathy.
Term infants (≥ 36 weeks of gestation) will have to be at risk of hypocapnia to be eligible, as defined by a temperature corrected pCO2 ≤ 40 mmHg in blood gas analysis, at any time within six hours of life.
The gas mixture will be administered through patient circuits in conventional ventilators. Administered CO2 level will be closely monitored at the inhalation circuit (constant 5% = 36 mmHg). Blood gas samples will be taken hourly to ensure targeted and tolerable pCO2 levels.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypoxic-Ischemic Encephalopathy Therapy Optimization for Better Neuroprotection With Inhalative CO2 in Asphyxiated, Cooled, Mechanically Ventilated Neonates at Risk for Hypocapnia|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||February 2020|
Experimental: 5% carbon-dioxide inhalation
5% carbon-dioxide will be administered through patient circuits to asphyxiated, cooled, mechanically ventilated newborns at risk for hypocapnia
Other: 5% carbon-dioxide inhalation
5% CO2 (36 mmHg) and 95% air gas mixture inhalation, for a maximum of 12 hours or until metabolic acidosis recovery occurs as measured by BE > -5 mmol/L in arterial blood gas samples
Other Name: N-Carbogen
- Percentage of time spent in the desired pCO2 range of 40-60 mmHg (temp. corrected) during CO2 inhalation. [ Time Frame: 3 days ]
- Number of seizures, either detected clinically or by amplitude integrated EEG monitoring [ Time Frame: Within one week ]
- Time until the end point of metabolic acidosis (BE > -5 mmol/L) [ Time Frame: During CO2 inhalation (max. 12 hours) ]
- Time until the end point of acidosis (pH > 7.25) [ Time Frame: During therapeutic hypothermia (max. 72 hours) ]
- Severe hypotension (mean arterial pressure less than 25 mmHg), despite full inotrope support and volume replacement. [ Time Frame: During therapeutic hypothermia (max. 72 hours) ]
- Intracranial haemorrhage detected by MRI [ Time Frame: Within seven days ]
- Reduction in Lac/NAA ratio on magnetic resonance spectroscopy [ Time Frame: Within seven days ]
- Preserved fractional anisotropy measured on diffusion weighted MRI [ Time Frame: Within seven days ]
- Death [ Time Frame: Within one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700854
|Contact: Enikő Szakmár, MDemail@example.com|
|Contact: Ágnes Jermendy, MD, PhD, MPHfirstname.lastname@example.org|
|Semmelweis University, 1st Department of Pediatrics||Recruiting|
|Budapest, Hungary, 1085|
|Contact: Viktória Ollé +36 (1) 3343186 x 52620 email@example.com|
|Study Director:||Miklós Szabó, MD, PhD||Semmelweis University, 1st Department of Pediatrics|