Work of Breathing and Oxygen Saturation Stability in Premature Infants With History of Respiratory Insufficiency Prior to Discharge

Work of Breathing in Premature Infants at Discharge

Sponsors

Lead sponsor: Christiana Care Health Services

Source Christiana Care Health Services
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.

Overall Status Not yet recruiting
Start Date May 1, 2020
Completion Date July 31, 2020
Primary Completion Date June 30, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Work of breathing indices 25 minutes
Secondary Outcome
Measure Time Frame
Intermittent Hypoxia 25 minutes
Enrollment 62
Condition
Intervention

Intervention type: Other

Intervention name: Enrollment

Description: All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.

Eligibility

Sampling method: Non-Probability Sample

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

Minimum age: 1 Month

Maximum age: 7 Months

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kelley Z Kovatis, MD Principal Investigator ChristianaCare
Overall Contact

Last name: Kelley Z Kovatis, MD

Phone: 302-733-2410

Email: [email protected]

Location
facility Christiana Care Health Services, Inc
Location Countries

United States

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)

Description: Preterm infants who were on oxygen at 28 days of life.

Arm group label: Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD

Description: Preterm infants who were not on oxygen at 28 days of life.

Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov