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

NCT04971694 | Completed

• 1 other identifier: 830900795
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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).

Conditions

BPD - Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (3)

• 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

• To assess the impact of steroid practices on BPD outcomes in these infants

  \- Presence of prenatal steroid administration

  30 days

• To assess the impact of steroid practices on BPD outcomes in these infants

  \- Administration of steroids to the infant

  30 days

Secondary Outcomes (2)

• To determine if steroid use has an impact on infant growth

  30 days

• To determine if steroid use has an impact on NICU length of stay (LOS)

  30 days

Other Outcomes (2)

• To determine if the average fluid intake in the first week of life influences the severity of BPD

  1-6 days

• To determine if diuretic administration influences the severity of BPD

  1-6 days

Study Arms (1)

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

Interventions

No interventions or procedures OTHER

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.

Inclusion Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Infants born at \<30 weeks and/or \<1500g
• Admitted to BUMCP between January 1, 2019 and December 31, 2020

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatrix: lead
• Banner Health: collaborator
• Phoenix Children's Hospital: collaborator

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alejandra Valladolid, MD

  Banner University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: August 30, 2021
• Primary Completion: September 19, 2022
• Study Completion: July 6, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)