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

BPD - Bronchopulmonary Dysplasia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04971694
• Other study ID #: 830900795
• Status: Active, not recruiting
• Start date: September 8, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Pediatrix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• BPD - Bronchopulmonary Dysplasia
• Bronchopulmonary Dysplasia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Pediatrix	Banner Health, Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To determine if the average fluid intake in the first week of life influences the severity of BPD	- Fluid average from DOL 1-6	1-6 days
Other	To determine if diuretic administration influences the severity of BPD	- If applicable, the DOL of first furosemide and/or chlorothiazide doses	1-6 days
Primary	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	30 days
Primary	To assess the impact of steroid practices on BPD outcomes in these infants	- Presence of prenatal steroid administration	30 days
Primary	To assess the impact of steroid practices on BPD outcomes in these infants	- Administration of steroids to the infant	30 days
Secondary	To determine if steroid use has an impact on infant growth	- Collect growth and calculate the z-score at five intervals	30 days
Secondary	To determine if steroid use has an impact on NICU length of stay (LOS)	- NICU LOS in days	30 days