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

Completed

• Conditions: BPD - Bronchopulmonary Dysplasia
• Interventions: Other: No interventions or procedures

• Registration Number: NCT04971694
• Lead Sponsor: Pediatrix

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.

Study Timeline

• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-21
• Study Start: 2021-08-30
• Primary Completion: 2022-09-19
• Study Completion: 2024-07-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inclusion Group	No interventions or procedures	Infants born at \<30 weeks and/or \<1500g that were admitted to BUMCP between January 1, 2019 and December 31, 2020

Primary Outcome Measures

Name	Time	Method
To assess the impact of steroid practices on BPD outcomes in these infants	30 days	- Administration of steroids to the infant

Secondary Outcome Measures

Name	Time	Method
To determine if steroid use has an impact on infant growth	30 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

Trial Locations

Locations (1)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States