BPD Saturation TARgeting

Brief Title

BPD Saturation TARgeting

Official Title

The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial

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.
    

Study Type

Interventional

Primary Outcome

Intermittent hypoxemia (IH)

Secondary Outcome

 Duration of hypoxia

Condition

Bronchopulmonary Dysplasia

Intervention

LOWER oxygen saturation target group

Study Arms / Comparison Groups

 LOWER oxygen saturation target group

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

50

Start Date

June 1, 2018

Completion Date

November 1, 2022

Primary Completion Date

February 1, 2022

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
      

Gender

All

Ages

34 Weeks - 44 Weeks

Accepts Healthy Volunteers

No

Contacts

Sara DeMauro, MD, 267-426-4976, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT03385330

Organization ID

17-014522

Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital of Philadelphia

Collaborators

 Thrasher Research Fund

Study Sponsor

Sara DeMauro, MD, Principal Investigator, The Childrens Hospital of Pennsylvania

Verification Date

March 2021