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

BPD - Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04971694
• Other study ID #: 830900795
• Status: Active, not recruiting
• Start date: September 8, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Pediatrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

The investigators propose performing a retrospective analysis of the 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. The investigators are also going to explore the number and timing of diuretic medications and average fluid intake.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• BPD - Bronchopulmonary Dysplasia
• Bronchopulmonary Dysplasia

Intervention

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.

Locations

Country	Name	City	State
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Pediatrix	Banner Health, Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (36)

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. doi: 10.1007/pl00007563. Erratum In: Lung 1997;175(5):337. — View Citation

Baud O, Maury L, Lebail F, Ramful D, El Moussawi F, Nicaise C, Zupan-Simunek V, Coursol A, Beuchee 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. — View Citation

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

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. — View Citation

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. — View Citation

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. doi: 10.1097/00003246-197809000-00003. — View Citation

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. doi: 10.1056/NEJM197305242882102. No abstract available. — View Citation

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(10):CD001146. doi: 10.1002/14651858.CD001146.pub5. — View Citation

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(10):CD001145. doi: 10.1002/14651858.CD001145.pub4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1038/sj.jp.7200307. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1080/080352500750028898. — View Citation

Kersbergen KJ, de Vries LS, van Kooij BJ, Isgum I, Rademaker KJ, van Bel F, Huppi 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. — View Citation

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. — View Citation

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. doi: 10.1056/NEJM196702162760701. No abstract available. — View Citation

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. — View Citation

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. doi: 10.1016/j.jpeds.2005.06.039. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;2011(9):CD001817. doi: 10.1002/14651858.CD001817.pub2. — View Citation

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;2011(9):CD001453. doi: 10.1002/14651858.CD001453.pub2. — View Citation

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. doi: 10.1016/s0022-3476(97)70241-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To determine if the average fluid intake in the first week of life influences the severity of BPD	- Fluid average from DOL 1-6	1-6 days
Other	To determine if diuretic administration influences the severity of BPD	- If applicable, the DOL of first furosemide and/or chlorothiazide doses	1-6 days
Primary	To assess the impact of steroid practices on BPD outcomes in these infants	- The incidence of BPD stratified into three stages based on the type of support required at 36 weeks CGA	30 days
Primary	To assess the impact of steroid practices on BPD outcomes in these infants	- Presence of prenatal steroid administration	30 days
Primary	To assess the impact of steroid practices on BPD outcomes in these infants	- Administration of steroids to the infant	30 days
Secondary	To determine if steroid use has an impact on infant growth	- Collect growth and calculate the z-score at five intervals	30 days
Secondary	To determine if steroid use has an impact on NICU length of stay (LOS)	- NICU LOS in days	30 days