Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial
Abstract Background Bronchopulmonary dysplasia (BPD) is still a common complication in very premature infants. At present, there is no effective treatment for BPD. Glucocorticoids are drugs commonly used to prevent or treat BPD before and after birth. In very premature infants with high risk factors...
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BMC
2020-09-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-04698-0 |
| _version_ | 1818506903406247936 |
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| author | Yuan He Yong Zhang Shuqiang Gao Xiaoling Wang Na He Deshuang Zhang Wenbin Dong Christian Wieg Xiaoping Lei |
| author_facet | Yuan He Yong Zhang Shuqiang Gao Xiaoling Wang Na He Deshuang Zhang Wenbin Dong Christian Wieg Xiaoping Lei |
| author_sort | Yuan He |
| collection | DOAJ |
| description | Abstract Background Bronchopulmonary dysplasia (BPD) is still a common complication in very premature infants. At present, there is no effective treatment for BPD. Glucocorticoids are drugs commonly used to prevent or treat BPD before and after birth. In very premature infants with high risk factors for BPD, early use of dexamethasone can reduce the rate of death and/or BPD but may cause long-term adverse neurodevelopmental outcomes. Hydrocortisone (HC), as an alternative drug to dexamethasone, has been increasingly used to prevent BPD. However, no study has reported the efficacy and safety of HC to treat early BPD diagnosed at postnatal day (PND) 28. Methods This study protocol is for a multicenter double-blind randomized controlled trial of low-dose HC in the treatment of early BPD. Early BPD infants will be randomly assigned to the HC treatment group or control group. Infants in the HC group will receive 0.5 mg/kg HC twice a day for 7 days and then 0.5 mg/kg HC once a day for 3 days. The control group will be given the same volume of placebo and no intervention on the basis of routine treatment. The primary outcome is survival without moderate or severe BPD at 36 weeks postmenstrual age. Secondary outcomes are the short- and long-term effects on growth, metabolism, neurodevelopment, and other possible complications. Discussion This trial will determine the efficacy and safety of low-dose HC administration compared to placebo for the reduction of moderate or severe BPD at 36 weeks postmenstrual age in very preterm infants with early BPD. Trial registration China Clinical Trial Registration Center ChiCTR1900021854 . Registered on 13 March 2019. |
| first_indexed | 2024-12-10T22:10:59Z |
| format | Article |
| id | doaj.art-b6c6ed48bbf64b409c847373306b55b9 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T22:10:59Z |
| publishDate | 2020-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-b6c6ed48bbf64b409c847373306b55b92022-12-22T01:31:36ZengBMCTrials1745-62152020-09-012111710.1186/s13063-020-04698-0Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trialYuan He0Yong Zhang1Shuqiang Gao2Xiaoling Wang3Na He4Deshuang Zhang5Wenbin Dong6Christian Wieg7Xiaoping Lei8Department of Neonatology, Affiliated Hospital of Southwest Medical UniversityDepartment of Neonatology, Sichuan Provincial Hospital for Women and ChildrenDepartment of Neonatology, Chengdu Women’s and Children’s Central HospitalDepartment of Neonatology, Affiliated Hospital of Southwest Medical UniversityDepartment of Neonatology, Affiliated Hospital of Southwest Medical UniversityDepartment of Neonatology, Affiliated Hospital of Southwest Medical UniversityDepartment of Neonatology, Affiliated Hospital of Southwest Medical UniversityDepartment of Neonatology, Affiliated Hospital of Southwest Medical UniversityDepartment of Neonatology, Affiliated Hospital of Southwest Medical UniversityAbstract Background Bronchopulmonary dysplasia (BPD) is still a common complication in very premature infants. At present, there is no effective treatment for BPD. Glucocorticoids are drugs commonly used to prevent or treat BPD before and after birth. In very premature infants with high risk factors for BPD, early use of dexamethasone can reduce the rate of death and/or BPD but may cause long-term adverse neurodevelopmental outcomes. Hydrocortisone (HC), as an alternative drug to dexamethasone, has been increasingly used to prevent BPD. However, no study has reported the efficacy and safety of HC to treat early BPD diagnosed at postnatal day (PND) 28. Methods This study protocol is for a multicenter double-blind randomized controlled trial of low-dose HC in the treatment of early BPD. Early BPD infants will be randomly assigned to the HC treatment group or control group. Infants in the HC group will receive 0.5 mg/kg HC twice a day for 7 days and then 0.5 mg/kg HC once a day for 3 days. The control group will be given the same volume of placebo and no intervention on the basis of routine treatment. The primary outcome is survival without moderate or severe BPD at 36 weeks postmenstrual age. Secondary outcomes are the short- and long-term effects on growth, metabolism, neurodevelopment, and other possible complications. Discussion This trial will determine the efficacy and safety of low-dose HC administration compared to placebo for the reduction of moderate or severe BPD at 36 weeks postmenstrual age in very preterm infants with early BPD. Trial registration China Clinical Trial Registration Center ChiCTR1900021854 . Registered on 13 March 2019.http://link.springer.com/article/10.1186/s13063-020-04698-0Bronchopulmonary dysplasiaHydrocortisonePreterm infants |
| spellingShingle | Yuan He Yong Zhang Shuqiang Gao Xiaoling Wang Na He Deshuang Zhang Wenbin Dong Christian Wieg Xiaoping Lei Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial Trials Bronchopulmonary dysplasia Hydrocortisone Preterm infants |
| title | Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial |
| title_full | Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial |
| title_fullStr | Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial |
| title_full_unstemmed | Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial |
| title_short | Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial |
| title_sort | hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants study protocol for a randomized controlled trial |
| topic | Bronchopulmonary dysplasia Hydrocortisone Preterm infants |
| url | http://link.springer.com/article/10.1186/s13063-020-04698-0 |
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