Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled Trial
Background: Preterm neonates are at a high risk of respiratory depression at birth. Incidence of respiratory distress is reported in 60-80% of the neonates born with the gestational age of less than 28 weeks and 15-30% of the neonates with the gestational age of less than 32-34 weeks. The present st...
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| Format: | Article |
| Language: | English |
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Mashhad University of Medical Sciences
2017-09-01
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| Series: | Iranian Journal of Neonatology |
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| Online Access: | http://ijn.mums.ac.ir/article_9359_7225f1be155ab807ea3ead1ccd2af0a6.pdf |
| _version_ | 1819096232142831616 |
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| author | M Shivakumar Muhammad Najih Y Ramesh Bhat Purkayastha Jayashree Leslie Edward Simon Lewis Asha Kamath D Shashikala |
| author_facet | M Shivakumar Muhammad Najih Y Ramesh Bhat Purkayastha Jayashree Leslie Edward Simon Lewis Asha Kamath D Shashikala |
| author_sort | M Shivakumar |
| collection | DOAJ |
| description | Background: Preterm neonates are at a high risk of respiratory depression at birth. Incidence of respiratory distress is reported in 60-80% of the neonates born with the gestational age of less than 28 weeks and 15-30% of the neonates with the gestational age of less than 32-34 weeks. The present study aimed to compare the incidence and risk of failed extubation in using caffeine and aminophylline in the preterm neonates with the gestational age of ≤30 weeks in the periextubation period.Methods: This single-centered, parallel, open-label, randomized controlled trial was conducted in a tertiary care referral hospital in India during June 2014-2016. Neonates with the gestational age of ≤30 weeks who were intubated for a minimum of 24 hours were enrolled in the study. Neonates with major anomalies, heart disease, and sepsis were excluded from the study. After the random allocation of the infants to treatment with the standard dose of caffeine citrate and aminophylline methylxanthine, intubation continued for seven consecutive days with or without non-invasive ventilatory support. As the primary objective, the incidence and risk of failed extubation were assessed. Secondary objective of the research was to compare the relative incidence of acute adverse effects, persistent apnea, and the associated morbidities.Results: Neonates treated by caffeine were at a higher risk of extubation failure (1.09 times) adjusted with birth weight (31.5% versus 21.4%; RR=1.09; 95% CI: 0.81-1.46; P=0.55), which was not statistically significant. In addition, risk of apnea within seven days and after seven days of methylxanthine therapy was 1.57 (95% CI: 0.95-2.61) and 1.10 (95% CI: 0.95-2.61) times higher in the neonates with caffeine treatment. Also, rate of tachycardia was high in the neonates treated by aminophylline, which was statistically significant (RR=0.27; 95% CI: 0.13-0.56; P |
| first_indexed | 2024-12-21T23:55:55Z |
| format | Article |
| id | doaj.art-aab773f12def4eb3a22659a0f9fc497b |
| institution | Directory Open Access Journal |
| issn | 2251-7510 2322-2158 |
| language | English |
| last_indexed | 2024-12-21T23:55:55Z |
| publishDate | 2017-09-01 |
| publisher | Mashhad University of Medical Sciences |
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| series | Iranian Journal of Neonatology |
| spelling | doaj.art-aab773f12def4eb3a22659a0f9fc497b2022-12-21T18:45:49ZengMashhad University of Medical SciencesIranian Journal of Neonatology2251-75102322-21582017-09-0183111810.22038/ijn.2017.93599359Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled TrialM Shivakumar0Muhammad Najih1Y Ramesh Bhat2Purkayastha Jayashree3Leslie Edward Simon Lewis4Asha Kamath5D Shashikala6Department of Pediatrics, 1st Floor, Woman and Child Block, Kasturba Medical College, Madhav Nagar, Manipal University, Manipal, Karnataka, IndiaPediatric Critical Care, Great Ormond Street Hospital for Children, NHS Trust Foundation, Royal College of Pediatrics and Child Health, Ilford, Greater London, United Kingdom, IndiaDepartment of Pediatrics, 1st Floor, Woman and Child Block, Kasturba Medical College, Madhav Nagar, Manipal University, Manipal, Karnataka, IndiaDepartment of Pediatrics, 1st Floor, Woman and Child Block, Kasturba Medical College, Madhav Nagar, Manipal University, Manipal, Karnataka, IndiaDepartment of Pediatrics, 1st Floor, Woman and Child Block, Kasturba Medical College, Madhav Nagar, Manipal University, Manipal, Karnataka, IndiaDepartment of Community Medicine, Kasturba Medical College, Madhav Nagar, Manipal University, Manipal, Karnataka, IndiaDepartment of Pediatrics, 1st Floor, Woman and Child Block, Kasturba Medical College, Madhav Nagar, Manipal University, Manipal, Karnataka, IndiaBackground: Preterm neonates are at a high risk of respiratory depression at birth. Incidence of respiratory distress is reported in 60-80% of the neonates born with the gestational age of less than 28 weeks and 15-30% of the neonates with the gestational age of less than 32-34 weeks. The present study aimed to compare the incidence and risk of failed extubation in using caffeine and aminophylline in the preterm neonates with the gestational age of ≤30 weeks in the periextubation period.Methods: This single-centered, parallel, open-label, randomized controlled trial was conducted in a tertiary care referral hospital in India during June 2014-2016. Neonates with the gestational age of ≤30 weeks who were intubated for a minimum of 24 hours were enrolled in the study. Neonates with major anomalies, heart disease, and sepsis were excluded from the study. After the random allocation of the infants to treatment with the standard dose of caffeine citrate and aminophylline methylxanthine, intubation continued for seven consecutive days with or without non-invasive ventilatory support. As the primary objective, the incidence and risk of failed extubation were assessed. Secondary objective of the research was to compare the relative incidence of acute adverse effects, persistent apnea, and the associated morbidities.Results: Neonates treated by caffeine were at a higher risk of extubation failure (1.09 times) adjusted with birth weight (31.5% versus 21.4%; RR=1.09; 95% CI: 0.81-1.46; P=0.55), which was not statistically significant. In addition, risk of apnea within seven days and after seven days of methylxanthine therapy was 1.57 (95% CI: 0.95-2.61) and 1.10 (95% CI: 0.95-2.61) times higher in the neonates with caffeine treatment. Also, rate of tachycardia was high in the neonates treated by aminophylline, which was statistically significant (RR=0.27; 95% CI: 0.13-0.56; Phttp://ijn.mums.ac.ir/article_9359_7225f1be155ab807ea3ead1ccd2af0a6.pdfAminophyllineCaffeineExtubation failureMechanical ventilation |
| spellingShingle | M Shivakumar Muhammad Najih Y Ramesh Bhat Purkayastha Jayashree Leslie Edward Simon Lewis Asha Kamath D Shashikala Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled Trial Iranian Journal of Neonatology Aminophylline Caffeine Extubation failure Mechanical ventilation |
| title | Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled Trial |
| title_full | Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled Trial |
| title_fullStr | Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled Trial |
| title_full_unstemmed | Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled Trial |
| title_short | Prophylactic Methylxanthines for Preventing Extubation Failure in the Preterm Neonates with the Gestational Age of ≤30 Weeks: A Randomized Controlled Trial |
| title_sort | prophylactic methylxanthines for preventing extubation failure in the preterm neonates with the gestational age of ≤30 weeks a randomized controlled trial |
| topic | Aminophylline Caffeine Extubation failure Mechanical ventilation |
| url | http://ijn.mums.ac.ir/article_9359_7225f1be155ab807ea3ead1ccd2af0a6.pdf |
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