Work of Breathing in Premature Infants at Discharge

Completed

• Conditions: Bronchopulmonary Dysplasia; Very Low Birth Weight Infant; Prematurity
• Interventions: Other: Enrollment

• Registration Number: NCT03682575
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-24
• Study Start: 2020-11-10
• Primary Completion: 2022-11-17
• Study Completion: 2023-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD	Enrollment	Preterm infants who were not on oxygen at 28 days of life.
Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)	Enrollment	Preterm infants who were on oxygen at 28 days of life.

Primary Outcome Measures

Name	Time	Method
Work of breathing indices	25 minutes	Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured.

Secondary Outcome Measures

Name	Time	Method
Intermittent Hypoxia	25 minutes	Oxygen saturation will be measured using a high resolution pulse oximeter.

Trial Locations

Locations (1)

Christiana Care Health Services, Inc; 🇺🇸 Newark, Delaware, United States