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Objective <p>To determine the feasibility of oral doxapram dosing in very preterm infants.</p> Study design <p>Phase-two, open-label randomized trial&#xa0;(ACTRN12621001163897) of two oral doxapram regimens for ≥5 days: higher-dose 48 mg/kg, then 24 mg/kg/6 h vs. lower-dose 24 mg/kg, then 12 mg/kg/6 h. Eligibility: born&#xa0;&lt;32 weeks; CPAP&#xa0;≥8 cmH<sub>2</sub>O; caffeine citrate ≥15 mg/kg; significant apnea or desaturation (16 per group). Primary outcome: steady-state doxapram concentration in therapeutic range 1.5–4.0 mg/L, 2–4 h after 4–5<sup>th</sup> maintenance dose. Oximetry, gastric ultrasound and clinical assessment performed at baseline, day 2 and 5.</p> Results <p>2/16&#xa0;(13%) infants in the higher-dose and 7/15&#xa0;(47%) in the lower-dose group achieved steady state doxapram plasma concentrations in therapeutic range. Most infants (88%) in the higher-dose group had concentrations above therapeutic range. By day 5, oral doxapram increased mean SpO<sub>2</sub> and reduced FiO<sub>2</sub>, pCO<sub>2</sub>, and percentage time SpO<sub>2</sub> &lt;90%.</p> Conclusion <p>Oral doxapram is feasible in very preterm infants with improvements in oxygenation and ventilation. Lower doses (12 mg/kg/6 h) are sufficient in most infants.</p>

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Oral doxapram for apnea of prematurity: A randomized dosage trial

  • 期刊论文

  • 发表日期：

    2025年11月5日

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  • Jane M. Canning,
  • Jacqueline A. Hannam,
  • Julena Ardern,
  • Lisa C. Mravicich,
  • Michael P. Meyer,
  • Trusha J. Purohit,
  • Naibo Yin,
  • Sara M. Hanning,
  • Christopher J. D. McKinlay

摘要

Objective

To determine the feasibility of oral doxapram dosing in very preterm infants.

Study design

Phase-two, open-label randomized trial (ACTRN12621001163897) of two oral doxapram regimens for ≥5 days: higher-dose 48 mg/kg, then 24 mg/kg/6 h vs. lower-dose 24 mg/kg, then 12 mg/kg/6 h. Eligibility: born <32 weeks; CPAP ≥8 cmH2O; caffeine citrate ≥15 mg/kg; significant apnea or desaturation (16 per group). Primary outcome: steady-state doxapram concentration in therapeutic range 1.5–4.0 mg/L, 2–4 h after 4–5th maintenance dose. Oximetry, gastric ultrasound and clinical assessment performed at baseline, day 2 and 5.

Results

2/16 (13%) infants in the higher-dose and 7/15 (47%) in the lower-dose group achieved steady state doxapram plasma concentrations in therapeutic range. Most infants (88%) in the higher-dose group had concentrations above therapeutic range. By day 5, oral doxapram increased mean SpO2 and reduced FiO2, pCO2, and percentage time SpO2 <90%.

Conclusion

Oral doxapram is feasible in very preterm infants with improvements in oxygenation and ventilation. Lower doses (12 mg/kg/6 h) are sufficient in most infants.