Brief Title
Work of Breathing in Premature Infants at Discharge
Official Title
Work of Breathing and Oxygen Saturation Stability in Premature Infants With History of Respiratory Insufficiency Prior to Discharge
Brief Summary
The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.
Detailed Description
Work of breathing tests will be performed on premature infants who required oxygen for at least 28 days during their time in NICU. These same work of breathing tests will be performed in another group of premature infants who did not require oxygen for at least 28 days during their time in the NICU. The two groups will be compared.
Study Type
Observational
Primary Outcome
Work of breathing indices
Secondary Outcome
Intermittent Hypoxia
Condition
Bronchopulmonary Dysplasia
Intervention
Enrollment
Study Arms / Comparison Groups
Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)
Description: Preterm infants who were on oxygen at 28 days of life.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
62
Start Date
November 10, 2020
Completion Date
July 31, 2021
Primary Completion Date
June 30, 2021
Eligibility Criteria
Inclusion Criteria: - Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at birth. - Infants with diagnosis of BPD and without diagnosis of BPD Exclusion Criteria: - Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will be excluded.
Gender
All
Ages
1 Month - 7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Kelley Z Kovatis, MD, 302-733-2410, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03682575
Organization ID
DDD604122
Responsible Party
Sponsor
Study Sponsor
Christiana Care Health Services
Study Sponsor
Kelley Z Kovatis, MD, Principal Investigator, ChristianaCare
Verification Date
December 2020