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Original research
Late permissive hypercapnia and respiratory stability among very preterm infants: a pilot randomised trial
  1. Colm P Travers1,
  2. Waldemar A Carlo1,
  3. Arie Nakhmani2,
  4. Deborah Laney1,
  5. Rouba A Chahine3,
  6. Immaculada Aban3,
  7. Namasivayam Ambalavanan1
  1. 1 Department of Pediatrics, The University of Alabama at Birmingham, Birmingham, Alabama, USA
  2. 2 Department of Electrical and Computer Engineering, The University of Alabama at Birmingham, Birmingham, Alabama, USA
  3. 3 Department of Biostatistics, The University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA
  1. Correspondence to Dr Colm P Travers, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL 35249, USA; cptravers{at}uabmc.edu

Abstract

Objective Determine if targeting higher transcutaneous carbon dioxide improves respiratory stability among very preterm infants on ventilatory support.

Design Single-centre pilot randomised clinical trial.

Setting The University of Alabama at Birmingham.

Patients Very preterm infants on ventilatory support after postnatal day 7.

Interventions Infants were randomised to two different transcutaneous carbon dioxide levels targeting 5 mm Hg (0.67 kPa) changes with four sessions each lasting 24 hours for 96 hours: baseline-increase-baseline-increase or baseline-decrease-baseline-decrease.

Main outcome measures We collected cardiorespiratory data evaluating episodes of intermittent hypoxaemia (oxygen saturations (SpO2)<85% for ≥10 s), bradycardia (<100 bpm for ≥10 s), and cerebral and abdominal hypoxaemia on near-infrared spectroscopy.

Results We enrolled 25 infants with a gestational age of 24 w 6 d±11 d (mean±SD) and birth weight 645±142 g on postnatal day 14±3. Continuous transcutaneous carbon dioxide values (56.8±6.9 in the higher group vs 54.5±7.8 in the lower group; p=0.36) did not differ significantly between groups during the intervention days. There were no differences in intermittent hypoxaemia (126±64 vs 105±61 per 24 hours; p=0.30) or bradycardia (11±16 vs 15±23 per hour; p=0.89) episodes between groups. The proportion of time with SpO2<85%, SpO2<80%, cerebral hypoxaemia or abdominal hypoxaemia did not differ (all p>0.05). There was moderate negative correlation between mean transcutaneous carbon dioxide and bradycardia episodes (r=−0.56; p<0.001).

Conclusion Targeting 5 mm Hg (0.67 kPa) changes in transcutaneous carbon dioxide did not improve respiratory stability among very preterm infants on ventilatory support but the intended carbon dioxide separation was difficult to achieve and maintain.

Trial registration number NCT03333161.

  • neonatology
  • respiratory medicine

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/archdischild-2022-325166

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Contributors CPT made substantial contributions to study conceptualisation and design, methodology, investigation and drafting of the initial manuscript. WAC made substantial contributions to study conceptualisation and design, methodology, investigation and review or editing of the manuscript. AN made substantial contributions to methodology, data curation, formal analysis and review or editing of the manuscript. RAC made substantial contributions to formal analysis and review or editing of the manuscript. IA made substantial contributions to formal analysis and review or editing of the manuscript. NA made substantial contributions to study conceptualisation and design, methodology, investigation, supervision/oversight, funding acquisition, data curation, formal analysis and drafting of the initial manuscript, accepts full responsibility for the work and/or the conduct of the study and is responsible for the overall content as the study guarantor.

    • Funding This study was supported by grants from the National Institute of Health (NHLBI U01HL133536, U01HL133708 and K23HL157618).

    • Competing interests WAC is on the board of MEDNAX, Inc; NA is on the advisory board for Radiometer, Shire and Resbiotic.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.