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BPD Saturation TARgeting (BPD STAR)

Primary Purpose

Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LOWER oxygen saturation target group
HIGHER oxygen saturation target group
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring BPD, Prematurity, Supplemental Oxygen, Oximetry, Infants

Eligibility Criteria

34 Weeks - 44 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pre-term males or females infants born at <30 0/7 weeks gestation at birth
  • Current age 34 0/7 to 43 6/7 weeks postmenstrual age
  • Diagnosis of moderate or severe Bronchopulmonary Dysplasia based on the NIH consensus definition
  • Infant has never been discharged to home from the hospital

Exclusion Criteria:

  • Congenital anomaly or oncologic process likely to affect growth or respiratory status
  • Hemoglobinopathy or other blood disorder likely to affect oxygen saturations
  • Contraindication to nasal cannula use (for example, severe nasal septal breakdown).
  • Pulmonary hypertension requiring pharmacotherapy at the time of screening/enrollment.
  • Tracheostomy
  • Intubated during entire eligibility period

Sites / Locations

  • Children's Hospital of Philadelphia
  • University of Pennsylvania
  • Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LOWER oxygen saturation target group

HIGHER oxygen saturation target group

Arm Description

Oxygen saturation target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.

Oxygen saturation target range greater than or equal to 96%.The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.

Outcomes

Primary Outcome Measures

Intermittent hypoxemia (IH)
Incidence of intermittent hypoxia

Secondary Outcome Measures

Duration of hypoxia
Total exposure to hypoxia(cm)
Weight change
Growth in kilograms
Length change
Growth in centimeters
Head circumference change
Growth in centimeters
Weight-for-length change
Change in weight-for-length
Re-hospitalization
Rates of re-hospitalizations
Respiratory medication use
Incidence of respiratory medication use
Visits to emergency room or physician
Rates of visits to ER or physician for respiratory health-related problems
Quality of life
Quality of life, as measured by the Infant Toddler Quality of life Questionnaire (IT-QOL). Scores are reported on a scale from 0 (worst health) to 100 (best health).
Feeding
Quality of infant oral feeding skills, using questions adapted from the Millennium Baby Study.
Development
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.

Full Information

First Posted
December 11, 2017
Last Updated
September 6, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
Thrasher Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03385330
Brief Title
BPD Saturation TARgeting
Acronym
BPD STAR
Official Title
The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Thrasher Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Bronchopulmonary Dysplasia is diagnosed only in babies who are born prematurely, and affects about half of extremely preterm infants. The incidence of BPD has increased over time. It is most commonly defined as oxygen dependence at 36 weeks postmenstrual age (PMA). Infants with BPD face more than doubled odds of death after 36 weeks PMA or disability at 5 years compared to preterm infants without BPD. BPD is associated with abnormal lung function throughout childhood and significantly increases health care costs. Cognitive and respiratory outcomes are closely linked throughout the life course; thus, optimal long--term management of BPD during infancy may ultimately improve cognitive outcomes of this high--risk population. Supplemental oxygen is a lifesaving therapy for premature infants; yet, there is limited evidence about the safety or efficacy of using supplemental oxygen to target higher versus lower oxygen saturations in infants with established BPD. Infants between the ages of 34-44 weeks post-menstrual age with moderate or severe BPD will be randomly assigned to higher or lower oxygen saturation target ranges. The study intervention will begin in the hospital and will continue at home until 6 months corrected age. When infants are discharged with supplemental oxygen, this will be titrated according to a study algorithm in order to ensure that the target saturations are maintained throughout the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease
Keywords
BPD, Prematurity, Supplemental Oxygen, Oximetry, Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LOWER oxygen saturation target group
Arm Type
Active Comparator
Arm Description
Oxygen saturation target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.
Arm Title
HIGHER oxygen saturation target group
Arm Type
Active Comparator
Arm Description
Oxygen saturation target range greater than or equal to 96%.The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm.
Intervention Type
Other
Intervention Name(s)
LOWER oxygen saturation target group
Intervention Description
We will randomize infants with moderate or severe BPD to lower SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.
Intervention Type
Other
Intervention Name(s)
HIGHER oxygen saturation target group
Intervention Description
We will randomize infants with moderate or severe BPD to higher SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.
Primary Outcome Measure Information:
Title
Intermittent hypoxemia (IH)
Description
Incidence of intermittent hypoxia
Time Frame
Between discharge and 6 months corrected age
Secondary Outcome Measure Information:
Title
Duration of hypoxia
Description
Total exposure to hypoxia(cm)
Time Frame
Between discharge and 6 months corrected age
Title
Weight change
Description
Growth in kilograms
Time Frame
Between 40 weeks PMA and 6 months corrected age
Title
Length change
Description
Growth in centimeters
Time Frame
Between 40 weeks PMA and 6 months corrected age
Title
Head circumference change
Description
Growth in centimeters
Time Frame
Between 40 weeks PMA and 6 months corrected age
Title
Weight-for-length change
Description
Change in weight-for-length
Time Frame
Between 40 weeks PMA and 6 months corrected age
Title
Re-hospitalization
Description
Rates of re-hospitalizations
Time Frame
Between 40 weeks PMA and 6 months corrected age
Title
Respiratory medication use
Description
Incidence of respiratory medication use
Time Frame
Between 40 weeks PMA and 6 months corrected age
Title
Visits to emergency room or physician
Description
Rates of visits to ER or physician for respiratory health-related problems
Time Frame
Between 40 weeks PMA and 6 months corrected age
Title
Quality of life
Description
Quality of life, as measured by the Infant Toddler Quality of life Questionnaire (IT-QOL). Scores are reported on a scale from 0 (worst health) to 100 (best health).
Time Frame
At 3 months and at 6 months corrected age
Title
Feeding
Description
Quality of infant oral feeding skills, using questions adapted from the Millennium Baby Study.
Time Frame
At 3 months and at 6 months corrected age
Title
Development
Description
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.
Time Frame
At 6 months corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
44 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-term males or females infants born at <30 0/7 weeks gestation at birth Current age 34 0/7 to 43 6/7 weeks postmenstrual age Diagnosis of moderate or severe Bronchopulmonary Dysplasia based on the NIH consensus definition Infant has never been discharged to home from the hospital Exclusion Criteria: Congenital anomaly or oncologic process likely to affect growth or respiratory status Hemoglobinopathy or other blood disorder likely to affect oxygen saturations Contraindication to nasal cannula use (for example, severe nasal septal breakdown). Pulmonary hypertension requiring pharmacotherapy at the time of screening/enrollment. Tracheostomy Intubated during entire eligibility period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara DeMauro, MD
Organizational Affiliation
The Childrens Hospital of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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