BPD Saturation TARgeting

NCT03385330 | Completed Results DMC FDA Device

• 1 other identifier: 17-014522
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity; Chronic Lung Disease

Keywords

BPD; Prematurity; Supplemental Oxygen; Oximetry; Infants

Outcome Measures

Primary Outcomes (1)

• Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time

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

  Between discharge and 6 months corrected age

Secondary Outcomes (9)

• Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%

  Between discharge and 6 months corrected age

• Change in Weight Z-score

  Between randomization and 6 months corrected age

• Change in Length Z-score

  Between randomization and 6 months corrected age

• Change in Head Circumference Z-score

  Between randomization and 6 months corrected age

• Number of Participants With Re-hospitalization

  Between discharge and 6 months corrected age

Study Arms (2)

LOWER oxygen saturation target group

ACTIVE COMPARATOR

Oxygen saturation (SpO2) target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months corrected age (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.

Other: LOWER oxygen saturation target group

HIGHER oxygen saturation target group

ACTIVE COMPARATOR

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.

Other: HIGHER oxygen saturation target group

Interventions

LOWER oxygen saturation target group OTHER

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.

LOWER oxygen saturation target group

HIGHER oxygen saturation target group OTHER

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.

HIGHER oxygen saturation target group

Eligibility Criteria

• Age: 34 Weeks - 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Thrasher Research Fund: collaborator

Study Sites (3)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• DeMauro SB, Jensen EA, Passarella M, Gambacorta MC, Dhawan M, Weimer J, Jang S, Panitch H, Kirpalani H. Oxygen Saturation Targeting for Infants with Bronchopulmonary Dysplasia: A Pilot Randomized Trial. Ann Am Thorac Soc. 2025 Apr;22(4):560-569. doi: 10.1513/AnnalsATS.202404-443OC.

  PMID: 40167293 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Sara DeMauro
• Organization: Children's Hospital of Philadelphia

demauro@chop.edu

445-225-6400

Study Officials

• Sara DeMauro, MD

  The Childrens Hospital of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 28, 2017
• Study Start: June 1, 2018
• Primary Completion: February 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)