Impact of Steroid, Diuretic, and Fluid Use on BPD Outcomes

Overview

Assess the impact of steroid, diuretic, and fluid practices on BPD outcomes in extreme premature infants in the Banner – University Medical Center Phoenix (BUMCP) neonatal intensive care unit (NICU).

Full Title of Study: “A Retrospective Chart Review Evaluating the Impact of Steroid, Diuretic, and Fluid Use Practice Trends in Extreme Premature Infants at Risk for Bronchopulmonary Dysplasia (BPD) at a Single Center Neonatal Intensive Care Unit”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 2023

Detailed Description

We propose performing a retrospective analysis of our current respiratory management methods to potentially find a correlation between the number of steroid doses administered, the timing of initiation of steroid therapy and the effect on premature infants at risk for developing BPD. We are also going to explore the number and timing of diuretic medications and average fluid intake.

Interventions

  • Other: No interventions or procedures
    • This is a retrospective observational study and data will be collected from the subject’s existing medical record. No interventions or procedures will be required for this study.

Arms, Groups and Cohorts

  • Inclusion Group
    • Infants born at <30 weeks and/or <1500g that were admitted to BUMCP between January 1, 2019 and December 31, 2020

Clinical Trial Outcome Measures

Primary Measures

  • To assess the impact of steroid practices on BPD outcomes in these infants
    • Time Frame: 30 days
    • – The incidence of BPD stratified into three stages based on the type of support required at 36 weeks CGA
  • To assess the impact of steroid practices on BPD outcomes in these infants
    • Time Frame: 30 days
    • – Presence of prenatal steroid administration
  • To assess the impact of steroid practices on BPD outcomes in these infants
    • Time Frame: 30 days
    • – Administration of steroids to the infant

Secondary Measures

  • To determine if steroid use has an impact on infant growth
    • Time Frame: 30 days
    • – Collect growth and calculate the z-score at five intervals
  • To determine if steroid use has an impact on NICU length of stay (LOS)
    • Time Frame: 30 days
    • – NICU LOS in days

Participating in This Clinical Trial

Inclusion Criteria

  • Infants born at <30 weeks and/or <1500g – Admitted to BUMCP between January 1, 2019 and December 31, 2020 Exclusion Criteria:

  • Infants that do not survive to 36 weeks CGA, when the determination of BPD is made – Infants that are transferred to another hospital prior to 36 weeks CGA – Out born infants – Infants with life threatening congenital anomalies – Investigator discretion as to other factors which might impact the study

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Mednax Center for Research, Education, Quality and Safety
  • Collaborator
    • Banner Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alejandra Valladolid, MD, Principal Investigator, Banner University Medical Center
  • Overall Contact(s)
    • Christine Wade, 602-703-9041, christine_wade@mednax.com

References

Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68.

Guaman MC, Gien J, Baker CD, Zhang H, Austin ED, Collaco JM. Point Prevalence, Clinical Characteristics, and Treatment Variation for Infants with Severe Bronchopulmonary Dysplasia. Am J Perinatol. 2015 Aug;32(10):960-7. doi: 10.1055/s-0035-1547326. Epub 2015 Mar 4.

Jensen EA, Schmidt B. Epidemiology of bronchopulmonary dysplasia. Birth Defects Res A Clin Mol Teratol. 2014 Mar;100(3):145-57. doi: 10.1002/bdra.23235. Epub 2014 Mar 17. Review.

Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.

Sward-Comunelli SL, Mabry SM, Truog WE, Thibeault DW. Airway muscle in preterm infants: changes during development. J Pediatr. 1997 Apr;130(4):570-6.

Tiddens HA, Hofhuis W, Casotti V, Hop WC, Hulsmann AR, de Jongste JC. Airway dimensions in bronchopulmonary dysplasia: implications for airflow obstruction. Pediatr Pulmonol. 2008 Dec;43(12):1206-13. doi: 10.1002/ppul.20928.

O'Reilly M, Hooper SB, Allison BJ, Flecknoe SJ, Snibson K, Harding R, Sozo F. Persistent bronchiolar remodeling following brief ventilation of the very immature ovine lung. Am J Physiol Lung Cell Mol Physiol. 2009 Nov;297(5):L992-L1001. doi: 10.1152/ajplung.00099.2009. Epub 2009 Aug 28.

Ter Wolbeek M, Kavelaars A, de Vries WB, Tersteeg-Kamperman M, Veen S, Kornelisse RF, van Weissenbruch M, Baerts W, Liem KD, van Bel F, Heijnen CJ. Neonatal glucocorticoid treatment: long-term effects on the hypothalamus-pituitary-adrenal axis, immune system, and problem behavior in 14-17 year old adolescents. Brain Behav Immun. 2015 Mar;45:128-38. doi: 10.1016/j.bbi.2014.10.017. Epub 2014 Nov 8.

Cheong JL, Burnett AC, Lee KJ, Roberts G, Thompson DK, Wood SJ, Connelly A, Anderson PJ, Doyle LW; Victorian Infant Collaborative Study Group. Association between postnatal dexamethasone for treatment of bronchopulmonary dysplasia and brain volumes at adolescence in infants born very preterm. J Pediatr. 2014 Apr;164(4):737-743.e1. doi: 10.1016/j.jpeds.2013.10.083. Epub 2013 Dec 12.

Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Early (< 8 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10:CD001146. doi: 10.1002/14651858.CD001146.pub5. Review.

Zeng L, Tian J, Song F, Li W, Jiang L, Gui G, Zhang Y, Ge L, Shi J, Sun X, Mu D, Zhang L. Corticosteroids for the prevention of bronchopulmonary dysplasia in preterm infants: a network meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F506-F511. doi: 10.1136/archdischild-2017-313759. Epub 2018 Feb 23.

Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Late (> 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10:CD001145. doi: 10.1002/14651858.CD001145.pub4. Review.

Onland W, De Jaegere AP, Offringa M, van Kaam AH. Effects of higher versus lower dexamethasone doses on pulmonary and neurodevelopmental sequelae in preterm infants at risk for chronic lung disease: a meta-analysis. Pediatrics. 2008 Jul;122(1):92-101. doi: 10.1542/peds.2007-2258.

Onland W, Offringa M, De Jaegere AP, van Kaam AH. Finding the optimal postnatal dexamethasone regimen for preterm infants at risk of bronchopulmonary dysplasia: a systematic review of placebo-controlled trials. Pediatrics. 2009 Jan;123(1):367-77. doi: 10.1542/peds.2008-0016. Review.

Doyle LW, Ehrenkranz RA, Halliday HL. Postnatal hydrocortisone for preventing or treating bronchopulmonary dysplasia in preterm infants: a systematic review. Neonatology. 2010;98(2):111-7. doi: 10.1159/000279992. Epub 2010 Feb 12. Review.

Peltoniemi OM, Lano A, Yliherva A, Kari MA, Hallman M; Neonatal Hydrocortisone Working Group. Randomised trial of early neonatal hydrocortisone demonstrates potential undesired effects on neurodevelopment at preschool age. Acta Paediatr. 2016 Feb;105(2):159-64. doi: 10.1111/apa.13074. Epub 2015 Nov 5.

Baud O, Maury L, Lebail F, Ramful D, El Moussawi F, Nicaise C, Zupan-Simunek V, Coursol A, Beuchée A, Bolot P, Andrini P, Mohamed D, Alberti C; PREMILOC trial study group. Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial. Lancet. 2016 Apr 30;387(10030):1827-36. doi: 10.1016/S0140-6736(16)00202-6. Epub 2016 Feb 23.

Parikh NA, Kennedy KA, Lasky RE, McDavid GE, Tyson JE. Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes. J Pediatr. 2013 Apr;162(4):685-690.e1. doi: 10.1016/j.jpeds.2012.09.054. Epub 2012 Nov 8.

Parikh NA, Kennedy KA, Lasky RE, Tyson JE. Neurodevelopmental Outcomes of Extremely Preterm Infants Randomized to Stress Dose Hydrocortisone. PLoS One. 2015 Sep 16;10(9):e0137051. doi: 10.1371/journal.pone.0137051. eCollection 2015.

Kersbergen KJ, de Vries LS, van Kooij BJ, Išgum I, Rademaker KJ, van Bel F, Hüppi PS, Dubois J, Groenendaal F, Benders MJ. Hydrocortisone treatment for bronchopulmonary dysplasia and brain volumes in preterm infants. J Pediatr. 2013 Sep;163(3):666-71.e1. doi: 10.1016/j.jpeds.2013.04.001. Epub 2013 May 21.

Oh W, Poindexter BB, Perritt R, Lemons JA, Bauer CR, Ehrenkranz RA, Stoll BJ, Poole K, Wright LL; Neonatal Research Network. Association between fluid intake and weight loss during the first ten days of life and risk of bronchopulmonary dysplasia in extremely low birth weight infants. J Pediatr. 2005 Dec;147(6):786-90.

Slaughter JL, Stenger MR, Reagan PB. Variation in the use of diuretic therapy for infants with bronchopulmonary dysplasia. Pediatrics. 2013 Apr;131(4):716-23. doi: 10.1542/peds.2012-1835. Epub 2013 Mar 11.

Stewart A, Brion LP. Intravenous or enteral loop diuretics for preterm infants with (or developing) chronic lung disease. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD001453. doi: 10.1002/14651858.CD001453.pub2. Review.

Stewart A, Brion LP, Ambrosio-Perez I. Diuretics acting on the distal renal tubule for preterm infants with (or developing) chronic lung disease. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD001817. doi: 10.1002/14651858.CD001817.pub2. Review.

Sahni J, Phelps SJ. Nebulized furosemide in the treatment of bronchopulmonary dysplasia in preterm infants. J Pediatr Pharmacol Ther. 2011 Jan;16(1):14-22.

Segar JL. Neonatal diuretic therapy: furosemide, thiazides, and spironolactone. Clin Perinatol. 2012 Mar;39(1):209-20. doi: 10.1016/j.clp.2011.12.007. Epub 2011 Dec 29. Review.

Demling RH, Will JA. The effect of furosemide on the pulmonary transvascular fluid filtration rate. Crit Care Med. 1978 Sep-Oct;6(5):317-9.

Dikshit K, Vyden JK, Forrester JS, Chatterjee K, Prakash R, Swan HJ. Renal and extrarenal hemodynamic effects of furosemide in congestive heart failure after acute myocardial infarction. N Engl J Med. 1973 May 24;288(21):1087-90.

Lundergan CF, Fitzpatrick TM, Rose JC, Ramwell PW, Kot PA. Effect of cyclooxygenase inhibition on the pulmonary vasodilator response to furosemide. J Pharmacol Exp Ther. 1988 Jul;246(1):102-6.

Almirall JJ, Dolman CS, Eidelman DH. Furosemide-induced bronchodilation in the rat bronchus: evidence of a role for prostaglandins. Lung. 1997;175(3):155-63. Erratum in: Lung 1997;175(5):337.

Greenberg RG, Gayam S, Savage D, Tong A, Gorham D, Sholomon A, Clark RH, Benjamin DK, Laughon M, Smith PB; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Furosemide Exposure and Prevention of Bronchopulmonary Dysplasia in Premature Infants. J Pediatr. 2019 May;208:134-140.e2. doi: 10.1016/j.jpeds.2018.11.043. Epub 2018 Dec 20.

Hoffman DJ, Gerdes JS, Abbasi S. Pulmonary function and electrolyte balance following spironolactone treatment in preterm infants with chronic lung disease: a double-blind, placebo-controlled, randomized trial. J Perinatol. 2000 Jan-Feb;20(1):41-5.

Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2014;(12):CD000503. doi: 10.1002/14651858.CD000503.pub3. Epub 2014 Dec 4. Review.

Kavvadia V, Greenough A, Dimitriou G, Forsling ML. Randomized trial of two levels of fluid input in the perinatal period–effect on fluid balance, electrolyte and metabolic disturbances in ventilated VLBW infants. Acta Paediatr. 2000 Feb;89(2):237-41.

Chou JH, Roumiantsev S, Singh R. PediTools Electronic Growth Chart Calculators: Applications in Clinical Care, Research, and Quality Improvement. J Med Internet Res. 2020 Jan 30;22(1):e16204. doi: 10.2196/16204.

Olaloko O, Mohammed R, Ojha U. Evaluating the use of corticosteroids in preventing and treating bronchopulmonary dysplasia in preterm neonates. Int J Gen Med. 2018 Jul 3;11:265-274. doi: 10.2147/IJGM.S158184. eCollection 2018. Review.

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