Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized contro
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STUDY PROTOCOL
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Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial Yuan He1†, Yong Zhang2†, Shuqiang Gao3†, Xiaoling Wang1, Na He1, Deshuang Zhang1, Wenbin Dong1,4,5, Christian Wieg1,5,6* and Xiaoping Lei1,4,5*
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. Keywords: Bronchopulmonary dysplasia, Hydrocortisone, Preterm infants
Background Bronchopulmonary dysplasia (BPD) is a serious complication in very preterm infants, and the incidence has been no significant decrease in the past two decades [1]. When BPD is present in preterm infants, mortality and * Correspondence: [email protected]; [email protected] † Yuan He, Yong Zhang, and Shuqiang Gao contributed equally and are the co-first authors. 1 Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou 646000, Sichuan, China Full list of author information is available at the end of the article
short- and long-term comorbidities are increased, and the need for health and education services is required more frequently than non-BPD infants later in life [2]. Since BPD was first described by Northway in 1967, the understanding of the pathophysiology evolved, and the definitions of BPD changed over time [3]. In 2001, the National Institute of Child Health and Human Development (NICHD) workshop defined BPD as the
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