NCT03385330: BPD STAR

BPD Saturation TARgeting

Completed NA Results posted Last updated 30 April 2024

What this trial tests

NA trial testing LOWER oxygen saturation target group in Bronchopulmonary Dysplasia in 50 participants. Completed in 1 September 2023.

Timeline

1 June 2018

Primary endpoint
1 February 2023

1 September 2023

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2018
Primary completion	1 February 2023
Estimated completion	1 September 2023
Sites	3 locations across United States

Drugs / interventions tested

• LOWER oxygen saturation target group
• HIGHER oxygen saturation target group

Conditions studied

• Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →
• Chronic Lung Disease of Prematurity — all drugs for Chronic Lung Disease of Prematurity →
• Chronic Lung Disease — all drugs for Chronic Lung Disease →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 34 Weeks to 44 Weeks, any sex, with Bronchopulmonary Dysplasia or Chronic Lung Disease of Prematurity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time Primary · Between discharge and 6 months corrected age

Incidence of intermittent hypoxia (IH, defined as SpO2 \<80% for \>=30 seconds), reported as median number of events per 8 hours of monitoring time.

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	2.2	1.0 – 4.2
HIGHER Oxygen Saturation Target Group	1.2	0.3 – 3.1

Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80% Secondary · Between discharge and 6 months corrected age

Total exposure to hypoxia - proportion of monitored time with SpO2 \<80%

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	0.005	0.001 – 0.016
HIGHER Oxygen Saturation Target Group	0.004	0.001 – 0.013

Change in Weight Z-score Secondary · Between randomization and 6 months corrected age

Change in weight Z-score. A Z-score of 0 represents average weight. Positive change in Z score indicates increasing weight relative to the population average weight. Negative change in Z score indicates decreasing weight relative to the population average weight.

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	0.6	± 1.4
HIGHER Oxygen Saturation Target Group	0.5	± 1.2

Change in Length Z-score Secondary · Between randomization and 6 months corrected age

Change in length Z-score. A Z-score of 0 represents average length. Positive change in Z score indicates increasing length relative to the population average length. Negative change in Z score indicates decreasing length relative to the population average length.

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	1.7	± 1.3
HIGHER Oxygen Saturation Target Group	1.2	± 1.4

Change in Head Circumference Z-score Secondary · Between randomization and 6 months corrected age

Change in head circumference (HC) Z-score. A Z-score of 0 represents average HC. Positive change in Z score indicates increasing HC relative to the population average HC. Negative change in Z score indicates decreasing HC relative to the population average HC.

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	0.5	± 1.3
HIGHER Oxygen Saturation Target Group	0.4	± 1.7

Number of Participants With Re-hospitalization Secondary · Between discharge and 6 months corrected age

Any re-hospitalization

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	9
HIGHER Oxygen Saturation Target Group	6

Number of Participants With Respiratory Medication Use Secondary · At 6 months corrected age

Number of patients with inhaled respiratory medication use

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	6
HIGHER Oxygen Saturation Target Group	6

Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons Secondary · Between discharge and 6 months corrected age

Any visits to ER or urgent care for respiratory health-related problems

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	5
HIGHER Oxygen Saturation Target Group	2

Feeding Secondary · At 6 months corrected age

Quality of infant oral feeding skills, parent reports that the child's feeding times are stressful or very stressful for themselves

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	1
HIGHER Oxygen Saturation Target Group	0

Development Secondary · At 6 months corrected age

Bayley Scales of Infant Development screening test, which is a standardized assessment of cognitive, motor, and language development in infancy and early childhood. Outcome will be reported as number of children considered "at risk" in any domain.

Group	Value	95% CI
LOWER Oxygen Saturation Target Group	8
HIGHER Oxygen Saturation Target Group	3

Sponsor's own description

Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alarm Burden in Infants With Bronchopulmonary Dysplasia Monitored With Pulse Oximetry at Home.
   Herrick HM, Passarella M, Weimer J, Bonafide CP, et al · · 2022 · cited 4× · PMID 35737392 · DOI 10.1001/jamanetworkopen.2022.18367
2. Oxygen Saturation Targeting for Infants with Bronchopulmonary Dysplasia: A Pilot Randomized Trial.
   DeMauro SB, Jensen EA, Passarella M, Gambacorta MC, et al · · 2025 · cited 3× · PMID 40167293 · DOI 10.1513/annalsats.202404-443oc