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

November 15, 2024 updated by: Pediatrix

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center Phoenix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants admitted to the BUMCP NICU at <30 weeks and/or <1500 grams (g)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inclusion Group
Infants born at <30 weeks and/or <1500g that were admitted to BUMCP between January 1, 2019 and December 31, 2020
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the impact of steroid practices on BPD outcomes in these infants
Time Frame: 30 days
- The incidence of BPD stratified into three stages based on the type of support required at 36 weeks CGA
30 days
To assess the impact of steroid practices on BPD outcomes in these infants
Time Frame: 30 days
- Presence of prenatal steroid administration
30 days
To assess the impact of steroid practices on BPD outcomes in these infants
Time Frame: 30 days
- Administration of steroids to the infant
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if steroid use has an impact on infant growth
Time Frame: 30 days
- Collect growth and calculate the z-score at five intervals
30 days
To determine if steroid use has an impact on NICU length of stay (LOS)
Time Frame: 30 days
- NICU LOS in days
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if the average fluid intake in the first week of life influences the severity of BPD
Time Frame: 1-6 days
- Fluid average from DOL 1-6
1-6 days
To determine if diuretic administration influences the severity of BPD
Time Frame: 1-6 days
- If applicable, the DOL of first furosemide and/or chlorothiazide doses
1-6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Collaborators

Phoenix Children's Hospital
Banner Health

Investigators

  • Principal Investigator: Alejandra Valladolid, MD, Banner University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Actual)

September 19, 2022

Study Completion (Actual)

July 6, 2024

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 830900795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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