BPD - Bronchopulmonary DysplasiaNCT04971694
Impact of Steroid, Diuretic, and Fluid Use on BPD Outcomes
An observational study of BPD - Bronchopulmonary Dysplasia, run by Pediatrix at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- BPD - Bronchopulmonary Dysplasia
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 6 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants admitted to the BUMCP NICU at <30 weeks and/or <1500 grams (g)
Who may be able to join
- Infants born at <30 weeks and/or <1500g
- Admitted to BUMCP between January 1, 2019 and December 31, 2020
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
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
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).
Read the 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.
- Conditions
- BPD - Bronchopulmonary Dysplasia
- Being tested
- No interventions or procedures
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions or proceduresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inclusion Group | Infants born at <30 weeks and/or <1500g that were admitted to BUMCP between January 1, 2019 and December 31, 2020 Receives: Other: No interventions or procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
To assess the impact of steroid practices on BPD outcomes in these infants
- Presence of prenatal steroid administration
Measured: 30 days
To assess the impact of steroid practices on BPD outcomes in these infants
- Administration of steroids to the infant
Measured: 30 days
Secondary outcomes (2)
To determine if steroid use has an impact on infant growth
- Collect growth and calculate the z-score at five intervals
Measured: 30 days
To determine if steroid use has an impact on NICU length of stay (LOS)
- NICU LOS in days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start30 Aug 2021
- Primary completion19 Sep 2022
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for BPD - Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Banner Health, Phoenix Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Alejandra Valladolid, MD, Principal investigator, Banner University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971694
- Sponsor's protocol ID
- 830900795
- Status last verified
- Nov 2024
- First submitted
- 12 Jul 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68. doi: 10.1056/NEJM196702162760701. No abstract available.
PubMed 5334613Guaman MC, Gien J, Baker CD, Zhang H, Austin ED, Collaco JM. Point Prevalence, Clinical Characteristics, and Treatment Variation for Infants with Severe Bronchopulmonary Dysplasia. Am J Perinatol. 2015 Aug;32(10):960-7. doi: 10.1055/s-0035-1547326. Epub 2015 Mar 4.
PubMed 25738785Jensen EA, Schmidt B. Epidemiology of bronchopulmonary dysplasia. Birth Defects Res A Clin Mol Teratol. 2014 Mar;100(3):145-57. doi: 10.1002/bdra.23235. Epub 2014 Mar 17.
PubMed 24639412Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.
PubMed 30995069Sward-Comunelli SL, Mabry SM, Truog WE, Thibeault DW. Airway muscle in preterm infants: changes during development. J Pediatr. 1997 Apr;130(4):570-6. doi: 10.1016/s0022-3476(97)70241-5.
PubMed 9108855Tiddens HA, Hofhuis W, Casotti V, Hop WC, Hulsmann AR, de Jongste JC. Airway dimensions in bronchopulmonary dysplasia: implications for airflow obstruction. Pediatr Pulmonol. 2008 Dec;43(12):1206-13. doi: 10.1002/ppul.20928.
PubMed 18991341O'Reilly M, Hooper SB, Allison BJ, Flecknoe SJ, Snibson K, Harding R, Sozo F. Persistent bronchiolar remodeling following brief ventilation of the very immature ovine lung. Am J Physiol Lung Cell Mol Physiol. 2009 Nov;297(5):L992-L1001. doi: 10.1152/ajplung.00099.2009. Epub 2009 Aug 28.
PubMed 19717553Ter Wolbeek M, Kavelaars A, de Vries WB, Tersteeg-Kamperman M, Veen S, Kornelisse RF, van Weissenbruch M, Baerts W, Liem KD, van Bel F, Heijnen CJ. Neonatal glucocorticoid treatment: long-term effects on the hypothalamus-pituitary-adrenal axis, immune system, and problem behavior in 14-17 year old adolescents. Brain Behav Immun. 2015 Mar;45:128-38. doi: 10.1016/j.bbi.2014.10.017. Epub 2014 Nov 8.
PubMed 25449580Cheong JL, Burnett AC, Lee KJ, Roberts G, Thompson DK, Wood SJ, Connelly A, Anderson PJ, Doyle LW; Victorian Infant Collaborative Study Group. Association between postnatal dexamethasone for treatment of bronchopulmonary dysplasia and brain volumes at adolescence in infants born very preterm. J Pediatr. 2014 Apr;164(4):737-743.e1. doi: 10.1016/j.jpeds.2013.10.083. Epub 2013 Dec 12.
PubMed 24332820Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Early (< 8 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10(10):CD001146. doi: 10.1002/14651858.CD001146.pub5.
PubMed 29063585Zeng L, Tian J, Song F, Li W, Jiang L, Gui G, Zhang Y, Ge L, Shi J, Sun X, Mu D, Zhang L. Corticosteroids for the prevention of bronchopulmonary dysplasia in preterm infants: a network meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F506-F511. doi: 10.1136/archdischild-2017-313759. Epub 2018 Feb 23.
PubMed 29475879Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Late (> 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10(10):CD001145. doi: 10.1002/14651858.CD001145.pub4.
PubMed 29063594Onland W, De Jaegere AP, Offringa M, van Kaam AH. Effects of higher versus lower dexamethasone doses on pulmonary and neurodevelopmental sequelae in preterm infants at risk for chronic lung disease: a meta-analysis. Pediatrics. 2008 Jul;122(1):92-101. doi: 10.1542/peds.2007-2258.
PubMed 18595991Onland W, Offringa M, De Jaegere AP, van Kaam AH. Finding the optimal postnatal dexamethasone regimen for preterm infants at risk of bronchopulmonary dysplasia: a systematic review of placebo-controlled trials. Pediatrics. 2009 Jan;123(1):367-77. doi: 10.1542/peds.2008-0016.
PubMed 19117904Doyle LW, Ehrenkranz RA, Halliday HL. Postnatal hydrocortisone for preventing or treating bronchopulmonary dysplasia in preterm infants: a systematic review. Neonatology. 2010;98(2):111-7. doi: 10.1159/000279992. Epub 2010 Feb 12.
PubMed 20150750
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04971694
- Acronym / sponsor ID
- 830900795
- Conditions
- BPD - Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Banner Health, Phoenix Children's Hospital
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 6 Jul 2024 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclusion Group | – | Other: No interventions or proceduresInfants born at <30 weeks and/or <1500g that were admitted to BUMCP between January 1, 2019 and December 31, 2020 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants admitted to the BUMCP NICU at <30 weeks and/or <1500 grams (g)
Key inclusion criteria (2 listed)
- Infants born at <30 weeks and/or <1500g
- Admitted to BUMCP between January 1, 2019 and December 31, 2020
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions or proceduresThis 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. | Other | Inclusion Group |
Primary outcome
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
To assess the impact of steroid practices on BPD outcomes in these infants
Time frame: 30 days
- Presence of prenatal steroid administration
To assess the impact of steroid practices on BPD outcomes in these infants
Time frame: 30 days
- Administration of steroids to the infant
2 secondary outcomes
To determine if steroid use has an impact on infant growth
Time frame: 30 days
To determine if steroid use has an impact on NICU length of stay (LOS)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 5334613Northway WH Jr, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline-membrane disease. Bronchopulmonary dysplasia. N Engl J Med. 1967 Feb 16;276(7):357-68. doi: 10.1056/NEJM196702162760701. No abstract available.
- Background: PubMed 25738785Guaman MC, Gien J, Baker CD, Zhang H, Austin ED, Collaco JM. Point Prevalence, Clinical Characteristics, and Treatment Variation for Infants with Severe Bronchopulmonary Dysplasia. Am J Perinatol. 2015 Aug;32(10):960-7. doi: 10.1055/s-0035-1547326. Epub 2015 Mar 4.
- Background: PubMed 24639412Jensen EA, Schmidt B. Epidemiology of bronchopulmonary dysplasia. Birth Defects Res A Clin Mol Teratol. 2014 Mar;100(3):145-57. doi: 10.1002/bdra.23235. Epub 2014 Mar 17.
- Background: PubMed 30995069Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.
- Background: PubMed 9108855Sward-Comunelli SL, Mabry SM, Truog WE, Thibeault DW. Airway muscle in preterm infants: changes during development. J Pediatr. 1997 Apr;130(4):570-6. doi: 10.1016/s0022-3476(97)70241-5.
- Background: PubMed 18991341Tiddens HA, Hofhuis W, Casotti V, Hop WC, Hulsmann AR, de Jongste JC. Airway dimensions in bronchopulmonary dysplasia: implications for airflow obstruction. Pediatr Pulmonol. 2008 Dec;43(12):1206-13. doi: 10.1002/ppul.20928.
- Background: PubMed 19717553O'Reilly M, Hooper SB, Allison BJ, Flecknoe SJ, Snibson K, Harding R, Sozo F. Persistent bronchiolar remodeling following brief ventilation of the very immature ovine lung. Am J Physiol Lung Cell Mol Physiol. 2009 Nov;297(5):L992-L1001. doi: 10.1152/ajplung.00099.2009. Epub 2009 Aug 28.
- Background: PubMed 25449580Ter Wolbeek M, Kavelaars A, de Vries WB, Tersteeg-Kamperman M, Veen S, Kornelisse RF, van Weissenbruch M, Baerts W, Liem KD, van Bel F, Heijnen CJ. Neonatal glucocorticoid treatment: long-term effects on the hypothalamus-pituitary-adrenal axis, immune system, and problem behavior in 14-17 year old adolescents. Brain Behav Immun. 2015 Mar;45:128-38. doi: 10.1016/j.bbi.2014.10.017. Epub 2014 Nov 8.
- Background: PubMed 24332820Cheong JL, Burnett AC, Lee KJ, Roberts G, Thompson DK, Wood SJ, Connelly A, Anderson PJ, Doyle LW; Victorian Infant Collaborative Study Group. Association between postnatal dexamethasone for treatment of bronchopulmonary dysplasia and brain volumes at adolescence in infants born very preterm. J Pediatr. 2014 Apr;164(4):737-743.e1. doi: 10.1016/j.jpeds.2013.10.083. Epub 2013 Dec 12.
- Background: PubMed 29063585Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Early (< 8 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10(10):CD001146. doi: 10.1002/14651858.CD001146.pub5.
- Background: PubMed 29475879Zeng L, Tian J, Song F, Li W, Jiang L, Gui G, Zhang Y, Ge L, Shi J, Sun X, Mu D, Zhang L. Corticosteroids for the prevention of bronchopulmonary dysplasia in preterm infants: a network meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F506-F511. doi: 10.1136/archdischild-2017-313759. Epub 2018 Feb 23.
- Background: PubMed 29063594Doyle LW, Cheong JL, Ehrenkranz RA, Halliday HL. Late (> 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 2017 Oct 24;10(10):CD001145. doi: 10.1002/14651858.CD001145.pub4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra Valladolid, MD principal investigator
Banner University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BPD - Bronchopulmonary Dysplasia, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the impact of steroid practices on BPD outcomes in these infants (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971694, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.