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Completed

NCT Number: NCT04971694

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

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).

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: 30 days

    • Presence of prenatal steroid administration

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

    Time frame: 30 days

    • Administration of steroids to the infant

Secondary outcomes

  1. 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

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

    Time frame: 30 days

    • NICU LOS in days

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Pediatrix

Other

Collaborators

  • Banner Health
  • Phoenix Children's Hospital

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jul 21, 2021
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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