Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy

NCT04603547 | Active Not Recruiting FDA Device

• 1 other identifier: 2019P001572
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or without respiratory support. Although, transcutaneous measurement of CO2 tension is the most commonly used non-invasive CO2 monitoring system in neonatal intensive care, to date tcPCO2 technique has not been evaluated systematically or used routinely in the intensive care of infants with neonatal encephalopathy receiving hypothermia treatment.

Conditions

Neonatal Encephalopathy

Keywords

Hypoxic-Ischemic Encephalopathy; Clinical NIRS (Near Infra-Red Spectroscopy); Therapeutic hypothermia; Perinatal Hypoxic Ischaemic; Hypocarbia in preterm infants; Blood carbon dioxide levels

Outcome Measures

Primary Outcomes (2)

• Agreement between the tcPCO2 and PCO2

  We will obtain both the measurement of transcutaneous carbon dioxide (tcPCO2) and PCO2 in neonates receiving therapeutic hypothermia. The agreement between the PCO2 and tcPCO2 values will be analyzed using Bland-Altman Plot, where the mean and standard deviation of differences between two measurements will be calculated.

  3 years

• Correlation between cerebral oxygen saturation and tcPCO2

  We will assess the correlation between cerebral oxygen saturation as a marker for cerebral perfusion and tcPCO2, as a marker of PCO2 in neonates receiving therapeutic hypothermia.

  3 years

Interventions

Transcutaneous Carbon Dioxide Monitoring DEVICE

Once an infant is identified as being eligible for TH treatment and hypothermia was initiated according to the department clinical practice guidelines, and written informed consent was obtained from one of the parents, tcPCO2 monitoring can be started. Transcutaneous CO2 will be measured by SenTec Digital Monitor (software version SW-V07.00; MPB SW-V05.00.12) with V-Sign™ Sensor (SenTec AG, Thervil, Switzerland). Also, we will use small blood samples (0.2 ml) from clinical blood draws up to 4 times following starting transcutaneous CO2 monitoring for measuring blood gas for research purposes.

Eligibility Criteria

• Age: 0 Days - 3 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with Neonatal Encephalopathy receiving therapeutic hypothermia

You may qualify if:

• Current criteria for therapeutic hypothermia at BWH include the following:
• ≥34 weeks' gestation
• Any one of the followings
• Sentinel event prior to delivery
• Apgar score ≤ 5 at 10 min
• Requires PPV, Intubation or CPR at 10 min
• pH ≤ 7.1 (from cord or blood gas within 60 min of birth) e. Abnormal Base Excess ≤ - 10 mEq/L (from cord or blood gas within 60 min of birth) +
• Any one of the followings:
• Neonatal Encephalopathy Scale Exam Score ≥4
• Seizure or clinical concern for seizure

You may not qualify if:

• Infants with major birth defect, genetic or metabolic syndrome
• Neonates in extremis with possibility of redirection to palliative care

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Medtronic: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (24)

• Nadeem M, Murray D, Boylan G, Dempsey EM, Ryan CA. Blood carbon dioxide levels and adverse outcome in neonatal hypoxic-ischemic encephalopathy. Am J Perinatol. 2010 May;27(5):361-5. doi: 10.1055/s-0029-1243309. Epub 2009 Dec 10.

  PMID: 20013576 BACKGROUND

• Edwards AD, Brocklehurst P, Gunn AJ, Halliday H, Juszczak E, Levene M, Strohm B, Thoresen M, Whitelaw A, Azzopardi D. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ. 2010 Feb 9;340:c363. doi: 10.1136/bmj.c363.

  PMID: 20144981 BACKGROUND

• Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.

  PMID: 23440789 BACKGROUND

• Kurinczuk JJ, White-Koning M, Badawi N. Epidemiology of neonatal encephalopathy and hypoxic-ischaemic encephalopathy. Early Hum Dev. 2010 Jun;86(6):329-38. doi: 10.1016/j.earlhumdev.2010.05.010. Epub 2010 Jun 16.

  PMID: 20554402 BACKGROUND

• 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.

  PMID: 21146184 BACKGROUND

• Laffey JG, Kavanagh BP. Hypocapnia. N Engl J Med. 2002 Jul 4;347(1):43-53. doi: 10.1056/NEJMra012457. No abstract available.

  PMID: 12097540 BACKGROUND

• Yenari MA, Han HS. Neuroprotective mechanisms of hypothermia in brain ischaemia. Nat Rev Neurosci. 2012 Feb 22;13(4):267-78. doi: 10.1038/nrn3174.

  PMID: 22353781 BACKGROUND

• 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. doi: 10.1136/adc.2003.048785.

  PMID: 15613575 BACKGROUND

• Lingappan K, Kaiser JR, Srinivasan C, Gunn AJ. Relationship between PCO2 and unfavorable outcome in infants with moderate-to-severe hypoxic ischemic encephalopathy. Pediatr Res. 2016 Aug;80(2):204-8. doi: 10.1038/pr.2016.62. Epub 2016 Apr 6.

  PMID: 27049290 BACKGROUND

• Lopez Laporte MA, Wang H, Sanon PN, Barbosa Vargas S, Maluorni J, Rampakakis E, Wintermark P. Association between hypocapnia and ventilation during the first days of life and brain injury in asphyxiated newborns treated with hypothermia. J Matern Fetal Neonatal Med. 2019 Apr;32(8):1312-1320. doi: 10.1080/14767058.2017.1404980. Epub 2017 Nov 27.

  PMID: 29129133 BACKGROUND

• Curley G, Laffey JG, Kavanagh BP. Bench-to-bedside review: carbon dioxide. Crit Care. 2010;14(2):220. doi: 10.1186/cc8926. Epub 2010 Apr 30.

  PMID: 20497620 BACKGROUND

• Greisen G. Autoregulation of cerebral blood flow in newborn babies. Early Hum Dev. 2005 May;81(5):423-8. doi: 10.1016/j.earlhumdev.2005.03.005.

  PMID: 15935919 BACKGROUND

• Greisen G, Munck H, Lou H. Severe hypocarbia in preterm infants and neurodevelopmental deficit. Acta Paediatr Scand. 1987 May;76(3):401-4. doi: 10.1111/j.1651-2227.1987.tb10489.x.

  PMID: 2440226 BACKGROUND

• Tingay DG, Stewart MJ, Morley CJ. Monitoring of end tidal carbon dioxide and transcutaneous carbon dioxide during neonatal transport. Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F523-6. doi: 10.1136/adc.2004.064717. Epub 2005 Apr 29.

  PMID: 15863489 BACKGROUND

• Sandberg KL, Brynjarsson H, Hjalmarson O. Transcutaneous blood gas monitoring during neonatal intensive care. Acta Paediatr. 2011 May;100(5):676-9. doi: 10.1111/j.1651-2227.2011.02164.x. Epub 2011 Feb 14.

  PMID: 21244487 BACKGROUND

• Hejlesen OK, Cichosz SL, Vangsgaard S, Andresen MF, Madsen LP. Clinical implications of a quality assessment of transcutaneous CO2 monitoring in preterm infants in neonatal intensive care. Stud Health Technol Inform. 2009;150:490-4.

  PMID: 19745360 BACKGROUND

• Aly S, El-Dib M, Mohamed M, Aly H. Transcutaneous Carbon Dioxide Monitoring with Reduced-Temperature Probes in Very Low Birth Weight Infants. Am J Perinatol. 2017 Apr;34(5):480-485. doi: 10.1055/s-0036-1593352. Epub 2016 Sep 27.

  PMID: 27673754 BACKGROUND

• Mukhopadhyay S, Maurer R, Puopolo KM. Neonatal Transcutaneous Carbon Dioxide Monitoring--Effect on Clinical Management and Outcomes. Respir Care. 2016 Jan;61(1):90-7. doi: 10.4187/respcare.04212. Epub 2015 Oct 27.

  PMID: 26508771 BACKGROUND

• Restrepo RD, Hirst KR, Wittnebel L, Wettstein R. AARC clinical practice guideline: transcutaneous monitoring of carbon dioxide and oxygen: 2012. Respir Care. 2012 Nov;57(11):1955-62. doi: 10.4187/respcare.02011.

  PMID: 23107301 BACKGROUND

• Sorensen LC, Brage-Andersen L, Greisen G. Effects of the transcutaneous electrode temperature on the accuracy of transcutaneous carbon dioxide tension. Scand J Clin Lab Invest. 2011 Nov;71(7):548-52. doi: 10.3109/00365513.2011.590601. Epub 2011 Jul 6.

  PMID: 21732731 BACKGROUND

• Chalak LF, Tarumi T, Zhang R. The "neurovascular unit approach" to evaluate mechanisms of dysfunctional autoregulation in asphyxiated newborns in the era of hypothermia therapy. Early Hum Dev. 2014 Oct;90(10):687-94. doi: 10.1016/j.earlhumdev.2014.06.013. Epub 2014 Jul 23.

  PMID: 25062804 BACKGROUND

• Vanderhaegen J, Naulaers G, Vanhole C, De Smet D, Van Huffel S, Vanhaesebrouck S, Devlieger H. The effect of changes in tPCO2 on the fractional tissue oxygen extraction--as measured by near-infrared spectroscopy--in neonates during the first days of life. Eur J Paediatr Neurol. 2009 Mar;13(2):128-34. doi: 10.1016/j.ejpn.2008.02.012. Epub 2008 Jul 10.

  PMID: 18619872 BACKGROUND

• Dix LML, Weeke LC, de Vries LS, Groenendaal F, Baerts W, van Bel F, Lemmers PMA. Carbon Dioxide Fluctuations Are Associated with Changes in Cerebral Oxygenation and Electrical Activity in Infants Born Preterm. J Pediatr. 2017 Aug;187:66-72.e1. doi: 10.1016/j.jpeds.2017.04.043. Epub 2017 May 31.

  PMID: 28578157 BACKGROUND

• Lasso Pirot A, Fritz KI, Ashraf QM, Mishra OP, Delivoria-Papadopoulos M. Effects of severe hypocapnia on expression of bax and bcl-2 proteins, DNA fragmentation, and membrane peroxidation products in cerebral cortical mitochondria of newborn piglets. Neonatology. 2007;91(1):20-7. doi: 10.1159/000096967. Epub 2007 Nov 10.

  PMID: 17344648 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oximetry; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Mohamed El-Dib, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 27, 2020
• Study Start: September 28, 2019
• Primary Completion: October 30, 2024
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 25, 2026

Record last verified: 2025-08

Locations

US (1)