Comparative efficacy and safety of caffeine and aminophylline for apnea of prematurity in preterm (≤34 weeks) neonates

A randomized controlled trial

M. Shivakumar, P. Jayashree, Muhammad Najih, Leslie Edward Simon Lewis, R. Ramesh Bhat, Asha Kamath, Shashikala

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objective: To compare the efficacy and safety of standard doses of Caffeine and Aminophylline for Apnea of prematurity. Study design: Randomized controlled trial. Setting: Tertiary-care referral centre and a teaching institution in Southern India. Trial was conducted from February 2012 to January 2015. Participants: 240 preterm (≤34 wk) neonates with apnea of prematurity. Interventions: Neonates randomized into two groups: Caffeine group received loading dose of caffeine citrate (20 mg/kg) followed by 5 mg/kg/day maintenance dose every 24 hour. Aminophylline group received loading dose of Aminophylline–5 mg/kg and maintenance dose of 1.5 mg/kg 8-hourly. Outcome measures: Difference in apneic spells, associated respiratory morbidity, and acute adverse events were assessed. Association of efficacy with therapeutic drug levels was also evaluated. Results: Infants on aminophylline experienced less apnea spells in 4-7 days of therapy (P=0.03). Mean apnea rate and isolated desaturations were similar in 1-3, 4-7 and 8-14 days of therapy. No difference was noted in duration of Neonatal Intensive Care Unit stay and hospital stay. Mean heart rate was significantly high in Aminophylline group (P<0.001). Risk of developing tachycardia was less (RR 0.30; 95% CI range 0.15 to 0.60; P<0.001) in Caffeine- over Aminophylline-treated infants. Conclusion: Aminophylline is as effective as caffeine for prevention of apneic spells in preterm neonates; however, dosage optimization needs to be done to reduce toxicity.

Original languageEnglish
Pages (from-to)279-283
Number of pages5
JournalIndian Pediatrics
Volume54
Issue number4
DOIs
Publication statusPublished - 01-04-2017

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Aminophylline
Apnea
Caffeine
Randomized Controlled Trials
Newborn Infant
Safety
Tertiary Care Centers
Neonatal Intensive Care Units
Tachycardia
India
Length of Stay
Teaching
Therapeutics
Heart Rate
Outcome Assessment (Health Care)
Morbidity
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

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title = "Comparative efficacy and safety of caffeine and aminophylline for apnea of prematurity in preterm (≤34 weeks) neonates: A randomized controlled trial",
abstract = "Objective: To compare the efficacy and safety of standard doses of Caffeine and Aminophylline for Apnea of prematurity. Study design: Randomized controlled trial. Setting: Tertiary-care referral centre and a teaching institution in Southern India. Trial was conducted from February 2012 to January 2015. Participants: 240 preterm (≤34 wk) neonates with apnea of prematurity. Interventions: Neonates randomized into two groups: Caffeine group received loading dose of caffeine citrate (20 mg/kg) followed by 5 mg/kg/day maintenance dose every 24 hour. Aminophylline group received loading dose of Aminophylline–5 mg/kg and maintenance dose of 1.5 mg/kg 8-hourly. Outcome measures: Difference in apneic spells, associated respiratory morbidity, and acute adverse events were assessed. Association of efficacy with therapeutic drug levels was also evaluated. Results: Infants on aminophylline experienced less apnea spells in 4-7 days of therapy (P=0.03). Mean apnea rate and isolated desaturations were similar in 1-3, 4-7 and 8-14 days of therapy. No difference was noted in duration of Neonatal Intensive Care Unit stay and hospital stay. Mean heart rate was significantly high in Aminophylline group (P<0.001). Risk of developing tachycardia was less (RR 0.30; 95{\%} CI range 0.15 to 0.60; P<0.001) in Caffeine- over Aminophylline-treated infants. Conclusion: Aminophylline is as effective as caffeine for prevention of apneic spells in preterm neonates; however, dosage optimization needs to be done to reduce toxicity.",
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Comparative efficacy and safety of caffeine and aminophylline for apnea of prematurity in preterm (≤34 weeks) neonates : A randomized controlled trial. / Shivakumar, M.; Jayashree, P.; Najih, Muhammad; Lewis, Leslie Edward Simon; Ramesh Bhat, R.; Kamath, Asha; Shashikala.

In: Indian Pediatrics, Vol. 54, No. 4, 01.04.2017, p. 279-283.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparative efficacy and safety of caffeine and aminophylline for apnea of prematurity in preterm (≤34 weeks) neonates

T2 - A randomized controlled trial

AU - Shivakumar, M.

AU - Jayashree, P.

AU - Najih, Muhammad

AU - Lewis, Leslie Edward Simon

AU - Ramesh Bhat, R.

AU - Kamath, Asha

AU - Shashikala,

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Objective: To compare the efficacy and safety of standard doses of Caffeine and Aminophylline for Apnea of prematurity. Study design: Randomized controlled trial. Setting: Tertiary-care referral centre and a teaching institution in Southern India. Trial was conducted from February 2012 to January 2015. Participants: 240 preterm (≤34 wk) neonates with apnea of prematurity. Interventions: Neonates randomized into two groups: Caffeine group received loading dose of caffeine citrate (20 mg/kg) followed by 5 mg/kg/day maintenance dose every 24 hour. Aminophylline group received loading dose of Aminophylline–5 mg/kg and maintenance dose of 1.5 mg/kg 8-hourly. Outcome measures: Difference in apneic spells, associated respiratory morbidity, and acute adverse events were assessed. Association of efficacy with therapeutic drug levels was also evaluated. Results: Infants on aminophylline experienced less apnea spells in 4-7 days of therapy (P=0.03). Mean apnea rate and isolated desaturations were similar in 1-3, 4-7 and 8-14 days of therapy. No difference was noted in duration of Neonatal Intensive Care Unit stay and hospital stay. Mean heart rate was significantly high in Aminophylline group (P<0.001). Risk of developing tachycardia was less (RR 0.30; 95% CI range 0.15 to 0.60; P<0.001) in Caffeine- over Aminophylline-treated infants. Conclusion: Aminophylline is as effective as caffeine for prevention of apneic spells in preterm neonates; however, dosage optimization needs to be done to reduce toxicity.

AB - Objective: To compare the efficacy and safety of standard doses of Caffeine and Aminophylline for Apnea of prematurity. Study design: Randomized controlled trial. Setting: Tertiary-care referral centre and a teaching institution in Southern India. Trial was conducted from February 2012 to January 2015. Participants: 240 preterm (≤34 wk) neonates with apnea of prematurity. Interventions: Neonates randomized into two groups: Caffeine group received loading dose of caffeine citrate (20 mg/kg) followed by 5 mg/kg/day maintenance dose every 24 hour. Aminophylline group received loading dose of Aminophylline–5 mg/kg and maintenance dose of 1.5 mg/kg 8-hourly. Outcome measures: Difference in apneic spells, associated respiratory morbidity, and acute adverse events were assessed. Association of efficacy with therapeutic drug levels was also evaluated. Results: Infants on aminophylline experienced less apnea spells in 4-7 days of therapy (P=0.03). Mean apnea rate and isolated desaturations were similar in 1-3, 4-7 and 8-14 days of therapy. No difference was noted in duration of Neonatal Intensive Care Unit stay and hospital stay. Mean heart rate was significantly high in Aminophylline group (P<0.001). Risk of developing tachycardia was less (RR 0.30; 95% CI range 0.15 to 0.60; P<0.001) in Caffeine- over Aminophylline-treated infants. Conclusion: Aminophylline is as effective as caffeine for prevention of apneic spells in preterm neonates; however, dosage optimization needs to be done to reduce toxicity.

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U2 - 10.1007/s13312-017-1088-0

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M3 - Article

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JO - Indian Pediatrics

JF - Indian Pediatrics

SN - 0019-6061

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