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      Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial

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          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.

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          Most cited references 25

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          Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial.

          Bronchopulmonary dysplasia, a major complication of extreme prematurity, has few treatment options. Postnatal steroid use is controversial, but low-dose hydrocortisone might prevent the harmful effects of inflammation on the developing lung. In this study, we aimed to assess whether low-dose hydrocortisone improved survival without bronchopulmonary dysplasia in extremely preterm infants.
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            Prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia: a multicenter trial.

            Infants developing bronchopulmonary dysplasia (BPD) show decreased cortisol response to adrenocorticotropic hormone. A pilot study of low-dose hydrocortisone therapy for prophylaxis of early adrenal insufficiency showed improved survival without BPD at 36 weeks' postmenstrual age, particularly in infants exposed to histologic chorioamnionitis. Mechanically ventilated infants with birth weights of 500 to 999 g were enrolled into this multicenter, randomized, masked trial between 12 and 48 hours of life. Patients received placebo or hydrocortisone, 1 mg/kg per day for 12 days, then 0.5 mg/kg per day for 3 days. BPD at 36 weeks' postmenstrual age was defined clinically (receiving supplemental oxygen) and physiologically (supplemental oxygen required for O2 saturation > or =90%). Patient enrollment was stopped at 360 patients because of an increase in spontaneous gastrointestinal perforation in the hydrocortisone-treated group. Survival without BPD was similar, defined clinically or physiologically, as were mortality, head circumference, and weight at 36 weeks. For patients exposed to histologic chorioamnionitis (n = 149), hydrocortisone treatment significantly decreased mortality and increased survival without BPD, defined clinically or physiologically. After treatment, cortisol values and response to adrenocorticotropic hormone were similar between groups. Hydrocortisone-treated infants receiving indomethacin had more gastrointestinal perforations than placebo-treated infants receiving indomethacin, suggesting an interactive effect. Prophylaxis of early adrenal insufficiency did not improve survival without BPD in the overall study population; however, treatment of chorioamnionitis-exposed infants significantly decreased mortality and improved survival without BPD. Low-dose hydrocortisone therapy did not suppress adrenal function or compromise short-term growth. The combination of indomethacin and hydrocortisone should be avoided.
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              Policy statement--postnatal corticosteroids to prevent or treat bronchopulmonary dysplasia.

               Kristi Watterberg,   (2010)
              The purpose of this revised statement is to review current information on the use of postnatal glucocorticoids to prevent or treat bronchopulmonary dysplasia in the preterm infant and to make updated recommendations regarding their use. High-dose dexamethasone (0.5 mg/kg per day) does not seem to confer additional therapeutic benefit over lower doses and is not recommended. Evidence is insufficient to make a recommendation regarding other glucocorticoid doses and preparations. The clinician must use clinical judgment when attempting to balance the potential adverse effects of glucocorticoid treatment with those of bronchopulmonary dysplasia.
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                Author and article information

                Contributors
                Christian.Wieg@klinikum-ab-alz.de
                leixiaopingde@126.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                3 September 2020
                3 September 2020
                2020
                : 21
                Affiliations
                [1 ]GRID grid.488387.8, Department of Neonatology, , Affiliated Hospital of Southwest Medical University, ; 25 Taiping Road, Luzhou, 646000 Sichuan China
                [2 ]Department of Neonatology, Sichuan Provincial Hospital for Women and Children, Chengdu, Sichuan China
                [3 ]GRID grid.489962.8, Department of Neonatology, , Chengdu Women’s and Children’s Central Hospital, ; Chengdu, Sichuan China
                [4 ]Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou, Sichuan China
                [5 ]GRID grid.488387.8, Department of Perinatology, , Affiliated Hospital of Southwest Medical University, ; Luzhou, Sichuan China
                [6 ]GRID grid.419800.4, ISNI 0000 0000 9321 629X, Department of Neonatology, , Klinikum Aschaffenburg, ; Am Hasenkopf 1, Aschaffenburg, 63739 Aschaffenburg, Bavaria Germany
                Article
                4698
                10.1186/s13063-020-04698-0
                7469331
                32883333
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                Funding
                Funded by: Southwest Medical University
                Award ID: 2015SX-0056
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2020

                Medicine

                bronchopulmonary dysplasia, hydrocortisone, preterm infants

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