The Journal of pediatrics · 2025
Atropine Versus Placebo for Neonatal Nonemergent Intubation: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Afifi Jehier, El-Naggar Walid, Hatfield Tara, Sandila Navjot, Baier John, Narvey Micheal
Аннотация
OBJECTIVE: To compare the rates of severe bradycardia (<80/min for >10 seconds) between neonates who received atropine-fentanyl-succinylcholine (atropine/standard-of-care group) vs placebo-fentanyl-succinylcholine (placebo/intervention group) before orotracheal intubation.
STUDY DESIGN: A multicenter, double-blind, randomized clinical trial of neonates receiving nonemergent intubation. Randomization was by computer generated tables with random block size, stratified by postmenstrual age at randomization (<34 weeks and ≥34 weeks). The primary outcome was severe bradycardia during the whole procedure (from administration of the study medication until completion of last successful intubation). Secondary outcomes included any bradycardia (<100/min for >10 seconds), number and duration of intubation attempts and hypoxemia (<80% for >10 seconds). Safety outcomes included profound bradycardia (<60/min for >10 seconds), and receipt of chest compression or epinephrine. Analysis was by intention to treat.
RESULTS: Seventy-three intubation events (60 infants) were randomized to administration of atropine (n = 24) or placebo (n = 49). Multiple attempts occurred in 33% of the events. No safety events occurred in either group. Severe bradycardia during the whole procedure was significantly higher in the placebo group compared with the atropine group (RR, 6.3; 95% CI, 1.2-34.1). The placebo group had significantly higher rates and duration of overall bradycardia, but lower rates and duration of hypoxemia compared with the atropine group, probably related to the lower proportion of multiple attempts (27% vs 46%; P = .09) and longer time to successful intubation (394 seconds vs 283 seconds; P = .08).
CONCLUSIONS: Among neonates receiving premedication for nonemergent intubation, atropine significantly decreased the rates and duration of severe and overall bradycardia compared with placebo.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT01595399 (https://clinicaltrials.gov/study/NCT01595399).
STUDY DESIGN: A multicenter, double-blind, randomized clinical trial of neonates receiving nonemergent intubation. Randomization was by computer generated tables with random block size, stratified by postmenstrual age at randomization (<34 weeks and ≥34 weeks). The primary outcome was severe bradycardia during the whole procedure (from administration of the study medication until completion of last successful intubation). Secondary outcomes included any bradycardia (<100/min for >10 seconds), number and duration of intubation attempts and hypoxemia (<80% for >10 seconds). Safety outcomes included profound bradycardia (<60/min for >10 seconds), and receipt of chest compression or epinephrine. Analysis was by intention to treat.
RESULTS: Seventy-three intubation events (60 infants) were randomized to administration of atropine (n = 24) or placebo (n = 49). Multiple attempts occurred in 33% of the events. No safety events occurred in either group. Severe bradycardia during the whole procedure was significantly higher in the placebo group compared with the atropine group (RR, 6.3; 95% CI, 1.2-34.1). The placebo group had significantly higher rates and duration of overall bradycardia, but lower rates and duration of hypoxemia compared with the atropine group, probably related to the lower proportion of multiple attempts (27% vs 46%; P = .09) and longer time to successful intubation (394 seconds vs 283 seconds; P = .08).
CONCLUSIONS: Among neonates receiving premedication for nonemergent intubation, atropine significantly decreased the rates and duration of severe and overall bradycardia compared with placebo.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT01595399 (https://clinicaltrials.gov/study/NCT01595399).