Clinical Trials Logo
  1. Home
  2. Bronchopulmonary Dysplasia
  3. NCT03682575
  4. Details
NCT03682575 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04936477 - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants N/A
Recruiting NCT05285345 - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Active, not recruiting NCT01632475 - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT00419588 - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Completed NCT00319956 - Trial II of Lung Protection With Azithromycin in the Preterm Infant Phase 2
Completed NCT00006401 - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00005376 - Premature Birth and Its Sequelae in Women N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT05152316 - The Baby Lung Study
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A