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NCT Number: NCT02700854

Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2

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.

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Key information

Conditions

Hypoxic-Ischaemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypocapnia Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Perinatal Asphyxia Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Semmelweis University, 1st Department of Pediatrics

Budapest, 1085, Hungary

About this study

Specific aims:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

5% carbon-dioxide inhalation

Other

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 names: N-Carbogen

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  1. Number of seizures, either detected clinically or by amplitude integrated EEG monitoring

    Time frame: Within one week

  2. Time until the end point of metabolic acidosis (BE > -5 mmol/L)

    Time frame: During CO2 inhalation (max. 12 hours)

  3. Time until the end point of acidosis (pH > 7.25)

    Time frame: During therapeutic hypothermia (max. 72 hours)

  4. Severe hypotension (mean arterial pressure less than 25 mmHg), despite full inotrope support and volume replacement.

    Time frame: During therapeutic hypothermia (max. 72 hours)

  5. Intracranial haemorrhage detected by MRI

    Time frame: Within seven days

  6. Reduction in Lac/NAA ratio on magnetic resonance spectroscopy

    Time frame: Within seven days

  7. Preserved fractional anisotropy measured on diffusion weighted MRI

    Time frame: Within seven days

  8. Death

    Time frame: Within one month

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Hypoxic-Ischemic Encephalopathy Therapy Optimization for Better Neuroprotection With Inhalative CO2 in Asphyxiated, Cooled, Mechanically Ventilated Neonates at Risk for Hypocapnia

Acronym: HENRIC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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