Impact of Steroid, Diuretic, and Fluid Use on BPD Outcomes
NCT ID: NCT04971694
Last Updated: 2024-11-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
175 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-08-30
Study Completion Date
2024-07-06
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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BPD - Bronchopulmonary Dysplasia
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
RETROSPECTIVE
Study Groups
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Inclusion Group
Infants born at \<30 weeks and/or \<1500g that were admitted to BUMCP between January 1, 2019 and December 31, 2020
No interventions or procedures
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Infants born at \<30 weeks and/or \<1500g
* Admitted to BUMCP between January 1, 2019 and December 31, 2020
* 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
* 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
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Banner Health
OTHER
Sponsor Role
collaborator
Phoenix Children's Hospital
OTHER
Sponsor Role
collaborator
Pediatrix
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alejandra Valladolid, MD
Role: PRINCIPAL_INVESTIGATOR
Banner University Medical Center
Locations
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Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Site Status
Countries
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United States
References
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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.
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BACKGROUND
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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.
Reference Type
BACKGROUND
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Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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BACKGROUND
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.
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BACKGROUND
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BACKGROUND
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BACKGROUND
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.
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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.
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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.
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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.
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Other Identifiers
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830900795
Identifier Type: -
Identifier Source: org_study_id
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