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Two Doses of Early Intravenous Dexamethasone for the Prevention of Bronchopulmonary Dysplasia in Babies with Respiratory Distress Syndrome1

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Two Doses of Early Intravenous Dexamethasone for the Prevention of Bronchopulmonary Dysplasia in Babies with Respiratory Distress Syndrome1 0031-3998/9413601-0122$03.00/0 PEDIATRIC RESEARCH Vol. 36, No. 1, 1994 Copyright 0 1994 International Pediatric Research Foundation, Inc. Printed in (I.S.A. Two Doses of Early Intravenous Dexamethasone for the Prevention of Bronchopulmonary Dysplasia in Babies with Respiratory Distress syndrome1 RAYMOND J. SANDERS,' CHRISTOPHER COX, DALE L. PHELPS, AND ROBERT A. SINKIN Departments of Pediatrics (Neonatology)[R. J. S., D. L. P., R.A. S. 1 and Biostatistics [C.C. I, Strong Children S Medical Center, Rochester, New York 14642 Bronchopulmonary dysplasia is an important complica- methasone group was 89% versus 67% in the placebo group tion of ventilation in babies for which treatment with ste- @ = 0.08, XZ analysis). Survival without bronchopulmo- roids has been advocated. We report the results of a phase nary dysplasia, diagnosed at 36 wk corrected gestational I study of early i.v. dexamethasone to prevent the devel- age, was 68% in the dexamethasone group versus 43% in opment of bronchopulmonary dysplasia in a high-risk pop- the placebo group @ = 0.14). Mean blood pressure was ulation of ventilated premature babies, < 30 wk gestation, elevated on study d 4 through 7 in the dexamethasone with surfactant-treated respiratory distress syndrome. This group, but this difference resolved by study d 10 without study used a limited dexamethasone dosing regimen to pharmacologic intervention. No differences in hyperglyce- minimize toxicity but used administration early in the mia, incidence of intraventricular hemorrhage (or its sever- course of acute lung disease to interrupt the injury cycle. ity), or days to regain birth weight were seen. Early ad- Forty babies were enrolled; 19 were randomized to receive ministration of dexamethasone resulted in short-term and dexamethasone (0.5 mglkg birth weight at 12-18 h of age suggested long-term benefits without significant complica- and a second dose 12 h later) and 21 were randomized to tions. The results of this trial justify a large scale, broader- receive placebo (i.v. saline). The dexamethasone group based (phase 11) trial in premature babies with respiratory required less ventilatory support (mean airway, peak in- distress syndrome to determine the limits of effectiveness spiratory and end expiratory pressures, and intermittent and the incidence of less-frequent potential side effects. mandatory ventilation) and supplemental oxygen after (Pediatr Res 36: 122-128, 1994) study d 4 (all p < 0.05, repeated measures analysis of variance). Improved tidal volume in the dexamethasone Abbreviations group, as measured by pulmonary function testing of in- BPD, bronchopulmonary dysplasia fants who remained intubated, was seen on study d 7 @ = FiO,, fraction of inspired oxygen concentration 0.02, t test). The dexamethasone group required shorter MAP, mean airway pressure hospitalizations (median of 95 d versus 106 d, p = 0.01) RDS, respiratory distress syndrome (proportional hazards regression). Survival in the dexa- CGA, corrected gestational age BPD is an important complication of current neonatal requiring home medical care and frequent outpatient vis- intensive care. Among survivors of neonatal intensive its (1-5). The incidence of BPD has an inverse relation- care, BPD remains a significant cause of prolonged hos- ship with birth weight and gestational age (6). With the pitalizations, rehospitalizations, and chronic disability development and application of exogenous surfactant replacement therapy for the treatment of RDS as well as other advances in neonatal care, survival of low birth Received August 4, 1993; accepted February 14. 1994. Correspondence and reprint requests: Robert A. Sinkin, M.D., Department of weight, extremely premature babies is increasing. The Pediatrics (Neonatology), Strong Children's Medical Center. University of Roch- greatest risk for the development of BPD accompanies ester, 601 Elmwood Ave.. Box 651, Rochester, NY 14642. the improved survival in this group of babies. Supported by a pulmonary SCOR grant from the NIH (HL-36543). a clinical research grant from the March of Dimes (6-0785) (R.A.S.), and a General Clinical Steroids have been used in a number of controlled Research Center grant (RR00044). trials to treat established BPD and have demonstrated 'Presented at the Society of Pediatric Research meeting, May 1992, Baltimore, significant short-term improvements in lung function (7- MD. 'Current address: NYU Medical Center, Department of Pediatrics Neonatal 9). Postulated mechanisms by which steroids might im- Program. 550 First Ave.. New York, NY 10018. prove lung function include the stabilization of cell and EARLY DEXAMETHASONE TO PREVENT BPD 123 lysosomal membranes, increase in surfactant synthesis, gestation, inclusive, who were born outside of or at the inhibition of prostaglandin and leukotriene synthesis, de- University of Rochester received exogenous surfactant if crease in neutrophil recruitment to the lung, enhance- they met specific criteria after admission. The purpose ment of (3-adrenergic activity, and reduction of pulmo- for requiring exogenous surfactant replacement therapy nary edema (10). A controlled trial of steroids in for study eligibility was to maintain as uniform a study ventilated premature babies, administered at 2 wk of age, population as possible. All infants were eligible to receive resulted in improved pulmonary and neurodevelopmental subsequent doses of exogenous surfactant if they contin- outcomes (11). Although these babies were treated early, ued to require mechanical ventilation with an MAP 1 7 before developing BPD by classic definitions (i.e. 28 d of torr, an FiOz r 0.4, or both. Exclusion criteria at entry age with an oxygen requirement and characteristic chest included a strong suspicion of sepsis or pneumonia (i.e. x-ray changes), this study did not address prophylactic chest x-ray findings not consistent with RDS, cardiovas- steroids to prevent the development of BPD. Evidence cular instability, neutropenia, severe maternal chorioam- suggests that the pathophysiology of BPD may begin nionitis), congenital heart disease, chromosomal abnor- shortly after birth in susceptible babies (12). One con- malities, and those infants who received an exchange trolled trial has investigated the use of prophylactic ste- transfusion. roids in babies with RDS before the development of BPD Randomization. After identification of eligible babies (13). In that study, early (<12 h) i.v. dexamethasone was and informed consent, an order form was sent to the given to premature babies with RDS, and the course was pharmacy. There babies were randomized to the dexa- tapered over a 12-d period (13). Infants were a mean of 30 methasone or placebo group according to a set of sealed wk gestation and surfactant was not used. The results envelopes. A syringe labeled "dexamethasone study showed improved pulmonary function, earlier extuba- drug," containing either the appropriate dose of dexa- tion, and a decreased incidence of lung injury in the methasone or normal saline placebo according to the treatment group; however, this group also demonstrated randomization schedule, was then sent to the nursery. A increased blood pressure, increased plasma glucose con- second syringe identical with the first was sent to the centrations, and delayed somatic growth (13). This raised nursery 12 h later. concerns over the safety of using steroids in a very-low- Intervention. The treatment group received one dose of birth-weight population. i.v. dexamethasone (0.5 mglkg birth weight) between 12 The potential for serious sequelae from the use of and 18 h of age and a second dose 12 h later. The placebo steroids in premature babies remains a concern. At the group received an equal volume of i.v. normal saline same time, we also wished to learn whether a benefit using the same dosing schedule. Investigators and care- could accrue to younger, surfactant-treated infants. takers were blinded to the study drug. All other aspects Therefore, we conducted a study to estimate the efficacy of care were according to the standard practice of the and safety of a short course of dexamethasone to venti- neonatal intensive care unit at the Strong Children's lator-dependent premature babies with surfactant-treated Medical Center. RDS. We limited the duration of dexamethasone admin- Short-term clinical outcome variables and pulmonary istration to two doses to reduce the potential risk for function testing. Short-term clinical outcome variables significant sequelae and to test our hypothesis that the were obtained on d 1 through 7 and d 10 of age and onset of BPD is based on an early inflammatory lung included weight, mean blood pressure, peak blood glu- injury. cose, complete blood counts with differential, need for insulin or antihypertensive therapies, need for pharma- METHODS cologic blood pressure support, and degree of ventilatory support. The latter included results of blood gas analysis This study was performed at the University of Roch- (pH and blood gas tension values) and ventilator settings: ester Medical and Strong Children's Research Centers, peak inspiratory pressure, peak end-expiratory pressure, Rochester, New York, from December 1989 through MAP, intermittent mandatory ventilation, and FiO,. Pul- January 1991. The study was approved by the Research monary function testing was scheduled for d 7 for those Subjects Review Board of the University and informed infants who remained ventilated, and determinations of consent was obtained from the babies' parents. minute ventilation,
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