Work of Breathing in Premature Infants at Discharge

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682575
• Other study ID #: DDD604122
• Status: Completed
• Start date: November 10, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 28, 2023
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 7 Months

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Prematurity
• Very Low Birth Weight Infant

Intervention

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

Locations

Country	Name	City	State
United States	Christiana Care Health Services, Inc	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work of breathing indices	Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured.	25 minutes
Secondary	Intermittent Hypoxia	Oxygen saturation will be measured using a high resolution pulse oximeter.	25 minutes