Perinatal Asphyxia Clinical Trial
— HENRICOfficial title:
Hypoxic-Ischemic Encephalopathy Therapy Optimization for Better Neuroprotection With Inhalative CO2 in Asphyxiated, Cooled, Mechanically Ventilated Neonates at Risk for Hypocapnia
Verified date | April 2021 |
Source | Semmelweis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University, 1st Department of Pediatrics | Budapest |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University |
Hungary,
Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854. Erratum in: N Engl J Med. 2010 Mar 18;362(11):1056. — View Citation
Klinger G, Beyene J, Shah P, Perlman M. Do hyperoxaemia and hypocapnia add to the risk of brain injury after intrapartum asphyxia? Arch Dis Child Fetal Neonatal Ed. 2005 Jan;90(1):F49-52. — View Citation
Laffey JG, Kavanagh BP. Hypocapnia. N Engl J Med. 2002 Jul 4;347(1):43-53. Review. — View Citation
Pappas A, Shankaran S, Laptook AR, Langer JC, Bara R, Ehrenkranz RA, Goldberg RN, Das A, Higgins RD, Tyson JE, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Hypocarbia and adverse outcome in neonatal hypoxic-ischemic encephalopathy. J Pediatr. 2011 May;158(5):752-758.e1. doi: 10.1016/j.jpeds.2010.10.019. Epub 2010 Dec 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of time spent in the desired pCO2 range of 40-60 mmHg (temp. corrected) during CO2 inhalation. | 3 days | ||
Secondary | Number of seizures, either detected clinically or by amplitude integrated EEG monitoring | Within one week | ||
Secondary | Time until the end point of metabolic acidosis (BE > -5 mmol/L) | During CO2 inhalation (max. 12 hours) | ||
Secondary | Time until the end point of acidosis (pH > 7.25) | During therapeutic hypothermia (max. 72 hours) | ||
Secondary | Severe hypotension (mean arterial pressure less than 25 mmHg), despite full inotrope support and volume replacement. | During therapeutic hypothermia (max. 72 hours) | ||
Secondary | Intracranial haemorrhage detected by MRI | Within seven days | ||
Secondary | Reduction in Lac/NAA ratio on magnetic resonance spectroscopy | Within seven days | ||
Secondary | Preserved fractional anisotropy measured on diffusion weighted MRI | Within seven days | ||
Secondary | Death | Within one month |
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