Lung Injury Clinical Trial
Official title:
Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.
Verified date | September 2015 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 72 Hours |
Eligibility |
Inclusion Criteria: 1. Birth weight greater than or equal to 1000 grams. 2. Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive). 3. Candidate for non-invasive respiratory support as a result of: 1. An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support. 2. An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support. 4. Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf. Exclusion Criteria: 1. Birth weight less than 1000 grams. 2. Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks. 3. Active air leak syndrome. 4. Subjects will not be eligible if they are not considered viable. 5. Infants with abnormalities of the upper and lower airways 6. Infants with significant abdominal or respiratory malformations . |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary mechanics and chest wall asynchrony measures. | Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP. | 2 years | No |
Secondary | Duration of respiratory support or oxygen use up to the time of discharge from the NICU. | The total number of days while infants are on any type of respiratory support or oxygen use prior to discharge in preterm infants treated with HHHFNC compared to NCPAP during their hospital stay. | 2 years | No |
Secondary | The incidence of potential adverse outcomes associated with HHHFNC or NCPAP. | The number and percentage of infants in each group with adverse effects such as facial and upper airways injury associated with the use of HHHFNC or NCPAP. | 2 years | No |
Secondary | Time needed to establish full enteral feeds | The total number of days needed to establish full enteral feeds in preterm infants treated with HHHFNC as compared to preterm infants treated with NCPAP. | 2 years | No |
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