N/A
N=50
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
Respiratory Distress Syndrome · Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT02249143 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants — 12.6; 6.4; 27.2; 17.1 mL — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP and room air (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants |
12.6; 6.4; 27.2; 17.1 | <0.05 sig |
| SECONDARY Measurements of Passive Respiratory Compliance in Randomized Premature Infants |
1.37; 1.32; 1.28; 1.17; 1.08; 1.12 | >0.05 |
| SECONDARY Passive Respiratory Resistance in Randomized Premature Infants |
0.054; 0.053; 0.061; 0.074; 0.073; 0.082 | — |
| SECONDARY Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants. |
7.1; 7.8; 7.6; 7.4; 7.3; 7.3 | — |
Summary
The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an increased functional residual capacity (at the end of the two week study period and prior to discharge) compared to those randomized to room air.
Eligibility Criteria
Inclusion Criteria
- Gestational age at birth <33 weeks
- Required CPAP for a minimum of 24 hours for respiratory distress
- Patient on CPAP and room air at time of randomization
Exclusion Criteria
- Complex congenital heart disease other than patent ductus arteriosus or atrial septal defect
- Major malformations or chromosomal anomalies
- Multiple gestation greater than twins
- Culture proven sepsis or unstable at time of randomization
Data sourced from ClinicalTrials.gov (NCT02249143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.