Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01HD115553-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure | Experimental | CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available. |
|
| Nasal Cannula | Active Comparator | HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Prior to study entry, the CPAP interface (includes RAM cannula, Optiflow, large bore cannulas, mask, prongs) and mode (bubble, variable-flow, ventilator-derived) used is at the discretion of the provider and center. After study entry, CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available. |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchopulmonary Dysplasia or Death | The likelihood of BPD or death at 36 weeks' Postmenstrual Age (PMA): a five-level ordinal outcome (death, survival with grade 3 BPD, survival with grade 2 BPD, survival with grade 1 BPD, and survival free of any BPD). | 36 Weeks' PMA |
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and off respiratory support | The number of days alive and off respiratory support from 34 weeks' to 40 weeks' PMA | 34-40 weeks' PMA |
| Mortality at 36 Weeks | Mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prematurity respiratory disease at two years follow up | Post-prematurity respiratory disease (PPRD) or death at 22-26 months follow-up. | 22-26 months |
| Pulmonary medications and respiratory support at two years follow up |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov).
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
This will be a randomized controlled trial with a 1:1 parallel allocation of infants to Continuous Positive Airway Pressure (CPAP) or Nasal Cannula (NC) using stratified permuted block design. Randomization will be stratified by gestational age (≥ 22 0/7 weeks to ≤ 24 6/7 weeks, ≥ 25 0/7 weeks to ≤ 26 6/7, and ≥ 27 0/7 to ≤ 28 6/7).
Not provided
Not provided
The inherent nature of ventilator/respiratory support interventions often precludes the ability to blind investigators and caregivers. As such, many studies in this domain face the limitation of not being blinded. The study team recognizes this limitation and will implement measures to mitigate potential biases arising from an unblinded trial. The DCC PI who will be overseeing the statistical team will be masked. Additionally, interim analysis (efficacy and safety) reports presented to the Data and Safety Monitoring Board (DSMB) will be masked.
Not provided
|
| Nasal Cannula | Device | HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion. |
|
| 36 Weeks' PMA |
| Death or Grade 2-3 BPD | Mortality at 36 weeks' PMA or grade 3 BPD | 36 Weeks' PMA |
| Death or Grade 3 BPD | Mortality or grade 3 BPD | 36 Weeks' PMA |
| Retinopathy of prematurity | Retinopathy of prematurity ≥ stage 3 or requiring treatment (laser/anti-VEGF) | 52 weeks' PMA |
| Respiratory support, supplemental oxygen, and pulmonary medications | Use of supplemental oxygen, respiratory support (including low-flow nasal cannula), and pulmonary medications (methylxanthines, steroids, diuretics, albuterol) at discharge and 40 weeks' PMA | 40 weeks' PMA |
| Full PO feedings | PMA at first full PO feeding (where full PO feeding is defined as intake of 120 mL/kg/day by mouth, even if an NG tube remains in situ) | 52 weeks' PMA |
| Length of hospitalization | Length of hospitalization from 34 weeks' PMA | 52 Weeks' PMA |
Pulmonary medications (inhaled or oral steroids, bronchodilators, diuretics, and vasodilators), history of rehospitalizations for respiratory reasons, pulmonary clinic visits, respiratory support (including oxygen, CPAP, or ventilation), bronchoscopy, and respiratory-related surgeries such as tracheal surgeries, repairs, and dilatations; and wheezing or diagnosis of asthma using a modified ISAAC questionnaire at 22-26 months follow-up.
| 22-26 months |
| Long-term mortality | Mortality at 22-28 month follow up | 22-26 months |
| Nasal/skin injury | Presence of nasal/skin injury during study intervention period | 36 Weeks' PMA |
| Nebulized epinephrine to treat Stridor | Nebulized epinephrine for stridor during intervention period | 36 Weeks' PMA |
| Tracheomalacia | Tracheomalacia diagnosed by bronchoscopy before discharge | 52 Weeks' PMA |
| Intubation, chest compressions/epinephrine | Intubation and/or chest compressions/epinephrine during study intervention period | 36 Weeks' PMA |
| Pneumothorax | Pneumothorax during study intervention period | 36 Weeks' PMA |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |