Clinical trial NCT04971694: Impact of Steroid, Diuretic, and Fluid Use on BPD Outcomes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BPD - Bronchopulmonary Dysplasia
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Banner Health
name: Phoenix Children's Hospital
First posted: 2021-07-21
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants admitted to the BUMCP NICU at \<30 weeks and/or \<1500 grams (g)

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the impact of steroid practices on BPD outcomes in these infants
timeFrame: 30 days
measure: To assess the impact of steroid practices on BPD outcomes in these infants
timeFrame: 30 days
measure: To assess the impact of steroid practices on BPD outcomes in these infants
timeFrame: 30 days
Secondary outcomes:
measure: To determine if steroid use has an impact on infant growth
timeFrame: 30 days
measure: To determine if steroid use has an impact on NICU length of stay (LOS)
timeFrame: 30 days
Other outcomes:
measure: To determine if the average fluid intake in the first week of life influences the severity of BPD
timeFrame: 1-6 days
measure: To determine if diuretic administration influences the severity of BPD
timeFrame: 1-6 days
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Banner University Medical Center
name: Alejandra Valladolid, MD
role: PRINCIPAL_INVESTIGATOR
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