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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04971694
Enrollment
175
Registered
2021-07-21
Start date
2021-08-30
Completion date
2024-07-06
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPD - Bronchopulmonary Dysplasia

Brief 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).

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.

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.

Sponsors

Banner Health
CollaboratorOTHER
Phoenix Children's Hospital
CollaboratorOTHER
Pediatrix
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To assess the impact of steroid practices on BPD outcomes in these infants30 days\- The incidence of BPD stratified into three stages based on the type of support required at 36 weeks CGA

Secondary

MeasureTime frameDescription
To determine if steroid use has an impact on infant growth30 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)30 days\- NICU LOS in days

Other

MeasureTime frameDescription
To determine if the average fluid intake in the first week of life influences the severity of BPD1-6 days\- Fluid average from DOL 1-6
To determine if diuretic administration influences the severity of BPD1-6 days\- If applicable, the DOL of first furosemide and/or chlorothiazide doses

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026