ClinicalTrials.gg
CompletedNCT04971694Updated Nov 19, 2024

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

An observational study in BPD - Bronchopulmonary Dysplasia, sponsored by Pediatrix. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Pediatrix · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
175
Sex
All
01

Study 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).

Read the detailed 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.

02

Conditions studied

  • BPD - Bronchopulmonary Dysplasia
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In context

Bronchopulmonary Dysplasia

362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.

This study's enrollment of 175 is above the median of 150 across 99 observational studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infants admitted to the BUMCP NICU at \<30 weeks and/or \<1500 grams (g)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
175 participants (actual)
Patient registry
No

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

    Other: No interventions or procedures

Interventions

  • OtherNo 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

  2. To assess the impact of steroid practices on BPD outcomes in these infants

    - Presence of prenatal steroid administration

    Time frame: 30 days

  3. To assess the impact of steroid practices on BPD outcomes in these infants

    - Administration of steroids to the infant

    Time frame: 30 days

Secondary outcomes

  1. To determine if steroid use has an impact on infant growth

    - Collect growth and calculate the z-score at five intervals

    Time frame: 30 days

  2. To determine if steroid use has an impact on NICU length of stay (LOS)

    - NICU LOS in days

    Time frame: 30 days

Other outcomes

  1. To determine if the average fluid intake in the first week of life influences the severity of BPD

    - Fluid average from DOL 1-6

    Time frame: 1-6 days

  2. To determine if diuretic administration influences the severity of BPD

    - If applicable, the DOL of first furosemide and/or chlorothiazide doses

    Time frame: 1-6 days

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Study locations

1 site
  • Banner University Medical Center Phoenix
    Phoenix, Arizona 85006, United States
08

References and documents

Publications

  • 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. PubMed 5334613 ↗
  • 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. PubMed 25738785 ↗
  • 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. PubMed 24639412 ↗
  • 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. PubMed 30995069 ↗
  • 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. PubMed 9108855 ↗
  • 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. PubMed 18991341 ↗
  • 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. PubMed 19717553 ↗
  • 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. PubMed 25449580 ↗
  • 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. PubMed 24332820 ↗
  • 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. PubMed 29063585 ↗
  • 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. PubMed 29475879 ↗
  • 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. PubMed 29063594 ↗
  • 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. PubMed 18595991 ↗
  • 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. PubMed 19117904 ↗
  • 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. PubMed 20150750 ↗
  • 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. PubMed 26058477 ↗
  • 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. PubMed 26916176 ↗
  • 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. PubMed 23140612 ↗
  • 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. PubMed 26376074 ↗
  • 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. PubMed 23706359 ↗
  • 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. PubMed 16356432 ↗
  • 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. PubMed 23478874 ↗
  • 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. PubMed 21901676 ↗
  • 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. PubMed 21901679 ↗
  • 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. PubMed 22477820 ↗
  • 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. PubMed 22341547 ↗
  • 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. PubMed 569036 ↗
  • 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. PubMed 4697939 ↗
  • 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. PubMed 3134540 ↗
  • 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. PubMed 9087943 ↗
  • 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. PubMed 30579586 ↗
  • 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. PubMed 10693099 ↗
  • 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. PubMed 25473815 ↗
  • 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. PubMed 10709897 ↗
  • 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. PubMed 32012066 ↗
  • 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. PubMed 30013381 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2021 to primary completion in Sep 2022, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2021
First posted
Jul 21, 2021
StartActual
Aug 30, 2021
Primary completionActual
Sep 19, 2022
CompletionActual
Jul 6, 2024
Last update
Nov 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04971694
Lead sponsor
Pediatrix
Collaborators
Banner Health, Phoenix Children's Hospital
Responsible party
Sponsor
First posted
Jul 21, 2021
Start date
Aug 30, 2021
Primary completion
Sep 19, 2022
Completion
Jul 6, 2024
Last update
Nov 19, 2024

Study contacts

Alejandra Valladolid, MD
principal investigator · Banner University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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