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| ID | Type | Description | Link |
|---|---|---|---|
| R33HL147906 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.
This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing. CPAP is a treatment widely used in the NICU in preterm infants right after they are born to help keep their lungs open/inflated. Although the benefit of CPAP after birth has been well studied, no one knows how long a stable preterm infant should stay on CPAP. The primary outcome of this study is to compare the lung volumes in the infants at 6 months of age by pulmonary function testing who were randomized to 2 extra weeks of CPAP in the NICU versus CPAP discontinuation, usual care. During the same pulmonary function test the investigators will also measure and compare how the infant's lungs diffuse gas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eCPAP | Experimental | Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met. |
|
| dCPAP | No Intervention | Participants will discontinue CPAP as per usual care once CPAP stability criteria is met. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional 2 weeks of CPAP | Other | Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar Volume | Establish that 2 additional weeks of CPAP in the NICU for stable preterm infants changes alveolar volume at approximately 6 months of age compared to infants who have CPAP discontinued, usual care. Measurements of alveolar volume were obtained at the same time as measurements of lung diffusion using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin. | 4 - 8 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Diffusion | Establish that 2 extra weeks of CPAP in stable preterm infants increases lung diffusion at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Measurements of lung diffusion were obtained at the same time as measurements of alveolar volume using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Occurrence of Wheeze | Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in lower respiratory morbidity through 12 months of age compared to infants who had CPAP discontinued, usual care. A standardized respiratory questionnaire was administered monthly through 12 months of age to ascertain this information on wheeze which was defined a priori. | through 12 months of age (+/- 2 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy McEvoy, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doernbecher Neonatal Care Center at Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31519441 | Background | Lam R, Schilling D, Scottoline B, Platteau A, Niederhausen M, Lund KC, Schelonka RL, MacDonald KD, McEvoy CT. The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial. J Pediatr. 2020 Feb;217:66-72.e1. doi: 10.1016/j.jpeds.2019.07.074. Epub 2019 Sep 10. | |
| 29265767 | Background | Praca ELL, Tiller CJ, Kisling JA, Tepper RS. An alternative method to measure the diffusing capacity of the lung for carbon monoxide in infants. Pediatr Pulmonol. 2018 Mar;53(3):332-336. doi: 10.1002/ppul.23926. Epub 2017 Dec 19. |
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Deidentified individual patient data related to primary outcome
One year after publication of primary paper, lasting for 5 years.
Signed data access agreement
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Continuous Positive Airway Pressure (eCPAP) | Participants will remain on continuous positive airway pressure (CPAP) for 2 additional weeks once CPAP stability criteria is met. Additional 2 weeks of CPAP: Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care. |
| FG001 | Discontinue Continuous Positive Airway Pressure (dCPAP) | Participants will discontinue CPAP as per usual care once CPAP stability criteria is met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of infants who were randomized to extended CPAP (eCPAP) or discontinue CPAP (dCPAP) if they were > 24 and ≤ 32 weeks of gestational age, had required CPAP for ≥ 24 hours for clinical care, and when they met predefined respiratory stability criteria. 54 stable preterm infants were randomized to eCPAP and 46 stable preterm infants were randomized to dCPAP.
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| ID | Title | Description |
|---|---|---|
| BG000 | eCPAP | Participants randomized to stay on CPAP for 2 additional weeks once CPAP stability criteria were met. |
| BG001 | dCPAP | Participants randomized to discontinue CPAP once CPAP stability criteria were met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alveolar Volume | Establish that 2 additional weeks of CPAP in the NICU for stable preterm infants changes alveolar volume at approximately 6 months of age compared to infants who have CPAP discontinued, usual care. Measurements of alveolar volume were obtained at the same time as measurements of lung diffusion using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin. | Decrease in the number of participants analyzed versus those initially randomized due to: Seven infants in the eCPAP arm did not complete VA testing due to the following reasons: 1 diagnosed with ARID1B mutation diagnosed after discharge and discontinued from study by the principal investigator; 1 with seizure disorder so could not be sedated; 3 mothers (one with a set of twins) refused sedation for the outpatient test; 1 infant with a technically unacceptable test. | Posted | Mean | Standard Error | mL | 4 - 8 months of age |
From consent through 12 months of age.
Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eCPAP | Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met. Additional 2 weeks of CPAP: Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vocal cord paralysis | Respiratory, thoracic and mediastinal disorders | MEDDRA code:10047674 | Systematic Assessment | Vocal cord paralysis on left post patent ductus arteriosus ligation. Determined to not be related to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinopathy of prematurity | Eye disorders | Systematic Assessment |
Single center randomized controlled trial which may limit generalizability. Testing required mild sedation. Testing equipment is not commercially available. The study did not include preterm infants with the most severe respiratory disease. The clinical outcome of wheeze was obtained by parental report rather than assessment by medical personnel, which may have affected the accuracy of the wheeze outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cindy McEvoy | OHSU | 503-494-0223 | mcevoyc@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2020 | Nov 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2023 | Nov 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 4 - 8 months of age |
| Forced Expiratory Flows at 50% of the Expired Volume (FEF50) | Establish that 2 extra weeks of CPAP in stable preterm infants increases forced expiratory flows at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Forced expiratory flows were measured using the raised volume rapid thoracic compression technique following specific American Thoracic Society and European Respiratory Society criteria for acceptance. | 4 - 8 months of age |
| Bayley III Gross Motor Scores | Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in improved neurodevelopmental outcomes (Bayley III Gross Motor Scores) through 12 months of age compared to infants who had CPAP discontinued, usual care. These exams were performed by a licensed psychologist in the neurodevelopmental clinic. | through 12 months of age (+/- 2 months) |
| 39977011 | Result | McEvoy CT, MacDonald KD, Go MA, Milner K, Harris J, Schilling D, Olson M, Tiller C, Slaven JE, Bjerregaard J, Vu A, Martin A, Mamidi R, Schelonka RL, Morris CD, Tepper RS. Extended Continuous Positive Airway Pressure in Preterm Infants Increases Lung Growth at 6 Months: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2025 Apr;211(4):610-618. doi: 10.1164/rccm.202411-2169OC. |
| 42190903 | Derived | Mamidi RR, Go MDA, Harris J, Olson M, Milner K, Tepper RS, Morris C, Park B, Schelonka R, MacDonald KD, McEvoy CT. Extended Continuous Positive Airway Pressure in Infants Born Preterm Decreases Intermittent Hypoxemia: A Secondary Analysis of a Randomized Controlled Trial. J Pediatr. 2026 May 25;296:115165. doi: 10.1016/j.jpeds.2026.115165. Online ahead of print. |
| BG002 | Total | Total of all reporting groups |
| weeks of postmenstrual age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | eCPAP | Participants will remain on CPAP for 2 additional weeks once CPAP stability criteria is met. Additional 2 weeks of CPAP: Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care. |
| OG001 | dCPAP | Participants will discontinue CPAP as per usual care once CPAP stability criteria is met. |
|
|
|
| Secondary | Lung Diffusion | Establish that 2 extra weeks of CPAP in stable preterm infants increases lung diffusion at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Measurements of lung diffusion were obtained at the same time as measurements of alveolar volume using an induced respiratory pause technique at an elevated lung volume of 30 cmH2O. During the passive expiration following the 4 second induced respiratory pause for gas exchange, carbon monoxide (CO) and helium (He) concentrations are used to calculate alveolar volume and lung diffusion. Results were expressed as averages of 2-3 measurements within 10%, adjusting for hemoglobin. | Decrease in the number of participants analyzed versus those initially randomized due to: Seven infants in the eCPAP arm did not complete VA testing due to the following reasons: 1 diagnosed with ARID1B mutation diagnosed after discharge and discontinued from study by the principal investigator; 1 with seizure disorder so could not be sedated; 3 mothers (one with a set of twins) refused sedation for the outpatient test; 1 infant with a technically unacceptable test. | Posted | Mean | Standard Error | mL/min/mmHg | 4 - 8 months of age |
|
|
|
|
| Secondary | Forced Expiratory Flows at 50% of the Expired Volume (FEF50) | Establish that 2 extra weeks of CPAP in stable preterm infants increases forced expiratory flows at approximately 6 months of age versus infants who have CPAP discontinued, usual care. Forced expiratory flows were measured using the raised volume rapid thoracic compression technique following specific American Thoracic Society and European Respiratory Society criteria for acceptance. | Decrease in the number of participants analyzed versus those initially randomized due to: Infants in the eCPAP arm did not complete VA testing due to the following reasons: 1 diagnosed with ARID1B mutation diagnosed after discharge and discontinued from study by the principal investigator; 1 with seizure disorder so could not be sedated; 3 mothers (one with a set of twins) refused sedation for the outpatient test; and remainder with technically unacceptable test. | Posted | Mean | Standard Error | mL/sec | 4 - 8 months of age |
|
|
|
|
| Other Pre-specified | Number of Participants With the Occurrence of Wheeze | Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in lower respiratory morbidity through 12 months of age compared to infants who had CPAP discontinued, usual care. A standardized respiratory questionnaire was administered monthly through 12 months of age to ascertain this information on wheeze which was defined a priori. | Posted | Count of Participants | Participants | through 12 months of age (+/- 2 months) |
|
|
|
|
| Other Pre-specified | Bayley III Gross Motor Scores | Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in improved neurodevelopmental outcomes (Bayley III Gross Motor Scores) through 12 months of age compared to infants who had CPAP discontinued, usual care. These exams were performed by a licensed psychologist in the neurodevelopmental clinic. | Not Posted | Oct 2025 | through 12 months of age (+/- 2 months) | Participants |
| 0 |
| 54 |
| 1 |
| 54 |
| 37 |
| 54 |
| EG001 | dCPAP | Participants will discontinue CPAP as per usual care once CPAP stability criteria is met. | 0 | 46 | 1 | 46 | 29 | 46 |
|
| streptococcus group B sepsis | Infections and infestations | MEDDRA:10080449 | Systematic Assessment | Streptococcus group B sepsis (late onset sepsis, requiring intubation). Determined not related to study. |
|
| Neonatal respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Apnea neonatal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Feeding disorder NOS | Metabolism and nutrition disorders | Systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal mucosal erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hemangioma of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anemia of prematurity | Eye disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Adjusted for gestational age at birth (stratification variable)
| >0.05 |
| Odds Ratio (OR) |
| 0.59 |
| 2-Sided |
| 95 |
| 0.27 |
| 1.31 |
| Superiority |