Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study
Background: Retinopathy of prematurity (ROP) is a disease of the retinal vessels in premature newborns and can lead to a wide range of vision disorders from minor correctable visual acuity defects to retinal detachment. The present study aimed to determine the efficacy of oral propranolol in the pre...
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| Format: | Article |
| Language: | English |
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Mashhad University of Medical Sciences
2023-01-01
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| Series: | Iranian Journal of Neonatology |
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| Online Access: | https://ijn.mums.ac.ir/article_22043_4afc1af663ad38ef090a38f324cb964d.pdf |
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| author | Pourang Mohammadi Homa Babaei Hadi Mohsenpour Pejvak Azadi |
| author_facet | Pourang Mohammadi Homa Babaei Hadi Mohsenpour Pejvak Azadi |
| author_sort | Pourang Mohammadi |
| collection | DOAJ |
| description | Background: Retinopathy of prematurity (ROP) is a disease of the retinal vessels in premature newborns and can lead to a wide range of vision disorders from minor correctable visual acuity defects to retinal detachment. The present study aimed to determine the efficacy of oral propranolol in the prevention of severe ROP.Methods: This randomized clinical trial study was conducted on 50 preterm newborns with retinopathy stage I or II without plus disease hospitalized at Imam Reza Hospital of Kermanshah city, Kermanshah, Iran. The samples were randomized into two groups (n=25 each). The intervention group received 0.5 mg/kg propranolol orally every 8 hours and was continued until retinal vascularization completion or the need for treatment by laser therapy or Avastin injection. In contrast, the control group received only routine care without receiving propranolol. Afterward, the two groups were compared in terms of progression to stage III and above of retinopathy, plus disease, retinal detachment, need for laser therapy or Avastin injection, and the duration of the retinal vascularization completion. Adverse events related to propranolol, such as hypoglycemia, hypotension, and bradycardia, were continuously monitored during the study. Finally, the data were entered into SPSS24 software and analyzed.Results: The two groups did not differ significantly in terms of demographic variables at the beginning of the study. The means of gestational age and numbers (%) of boys were 29±1.29 vs. 29.20±1.35 and 14 (56%) vs. 11 (44%) in the intervention and control groups, respectively. After the intervention, the duration of the completion of retinal vessels (day) was shorter in newborns receiving oral propranolol (61.04±6.13) than in the control group (70.08±5.72) (P<0.001). Moreover, the recovery rate from retinopathy and the incidence rate of plus disease were 88% vs. 68% and 4% vs. 12% in the intervention and control groups, respectively; however, this difference was not statistically significant (P>0.05). No adverse events related to propranolol were observed.Conclusion: Although the duration of the completion of retinal vascularization was shorter in newborns receiving oral propranolol, it was not effective in preventing severe ROP. Multicenter clinical trial studies with a higher sample size are recommended. |
| first_indexed | 2024-04-09T14:11:35Z |
| format | Article |
| id | doaj.art-09e90cf5a54242fabb1aa9334066a187 |
| institution | Directory Open Access Journal |
| issn | 2251-7510 2322-2158 |
| language | English |
| last_indexed | 2024-04-09T14:11:35Z |
| publishDate | 2023-01-01 |
| publisher | Mashhad University of Medical Sciences |
| record_format | Article |
| series | Iranian Journal of Neonatology |
| spelling | doaj.art-09e90cf5a54242fabb1aa9334066a1872023-05-06T06:31:19ZengMashhad University of Medical SciencesIranian Journal of Neonatology2251-75102322-21582023-01-011411710.22038/ijn.2023.70115.236122043Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial StudyPourang Mohammadi0Homa Babaei1Hadi Mohsenpour2Pejvak Azadi3School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, IranDepartment of Pediatrics, School of Medicine, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, IranDepartment of Pediatrics, School of Medicine, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, IranDepartment of Ophthalmology, School of Medicine, Imam Khomeini Hospital, Kermanshah University of Medical Sciences, Kermanshah, IranBackground: Retinopathy of prematurity (ROP) is a disease of the retinal vessels in premature newborns and can lead to a wide range of vision disorders from minor correctable visual acuity defects to retinal detachment. The present study aimed to determine the efficacy of oral propranolol in the prevention of severe ROP.Methods: This randomized clinical trial study was conducted on 50 preterm newborns with retinopathy stage I or II without plus disease hospitalized at Imam Reza Hospital of Kermanshah city, Kermanshah, Iran. The samples were randomized into two groups (n=25 each). The intervention group received 0.5 mg/kg propranolol orally every 8 hours and was continued until retinal vascularization completion or the need for treatment by laser therapy or Avastin injection. In contrast, the control group received only routine care without receiving propranolol. Afterward, the two groups were compared in terms of progression to stage III and above of retinopathy, plus disease, retinal detachment, need for laser therapy or Avastin injection, and the duration of the retinal vascularization completion. Adverse events related to propranolol, such as hypoglycemia, hypotension, and bradycardia, were continuously monitored during the study. Finally, the data were entered into SPSS24 software and analyzed.Results: The two groups did not differ significantly in terms of demographic variables at the beginning of the study. The means of gestational age and numbers (%) of boys were 29±1.29 vs. 29.20±1.35 and 14 (56%) vs. 11 (44%) in the intervention and control groups, respectively. After the intervention, the duration of the completion of retinal vessels (day) was shorter in newborns receiving oral propranolol (61.04±6.13) than in the control group (70.08±5.72) (P<0.001). Moreover, the recovery rate from retinopathy and the incidence rate of plus disease were 88% vs. 68% and 4% vs. 12% in the intervention and control groups, respectively; however, this difference was not statistically significant (P>0.05). No adverse events related to propranolol were observed.Conclusion: Although the duration of the completion of retinal vascularization was shorter in newborns receiving oral propranolol, it was not effective in preventing severe ROP. Multicenter clinical trial studies with a higher sample size are recommended.https://ijn.mums.ac.ir/article_22043_4afc1af663ad38ef090a38f324cb964d.pdfefficacyoral propranololretinopathy of prematurity |
| spellingShingle | Pourang Mohammadi Homa Babaei Hadi Mohsenpour Pejvak Azadi Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study Iranian Journal of Neonatology efficacy oral propranolol retinopathy of prematurity |
| title | Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study |
| title_full | Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study |
| title_fullStr | Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study |
| title_full_unstemmed | Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study |
| title_short | Efficacy of Oral Propranolol in Prevention of Severe Retinopathy of Prematurity: A Randomized Clinical Trial Study |
| title_sort | efficacy of oral propranolol in prevention of severe retinopathy of prematurity a randomized clinical trial study |
| topic | efficacy oral propranolol retinopathy of prematurity |
| url | https://ijn.mums.ac.ir/article_22043_4afc1af663ad38ef090a38f324cb964d.pdf |
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