Journal of perinatology : official journal of the California Perinatal Association · 2025
Oral doxapram for apnea of prematurity: A randomized dosage trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Canning Jane M, Hannam Jacqueline A, Ardern Julena, Mravicich Lisa C, Meyer Michael P, Purohit Trusha J, Yin Naibo, Hanning Sara M, McKinlay Christopher J D
Аннотация
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.
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.