Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Abbott Laboratories Grant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pontificia Universidad Javeriana | OTHER |
| Vanderbilt University School of Medicine | OTHER |
| Abbott | INDUSTRY |
| Fisher and Paykel Healthcare |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome. We hypothesize that premature infants exposed to very early NCPAP and surfactant will require less mechanical ventilation compared to those premature infants exposed to NCPAP alone.
Premature infants who are not intubated during the first 15 minutes of life and who develop clinical evidence of respiratory distress or need for oxygen requirement between 15 and 60 minutes of life, will be placed on bubble NCPAP of 6 cm H2O. Randomization envelops will them be opened and patients will be assigned to continuation on NCPAP alone (Control Group) or to NCPAP plus very early surfactant therapy (Treatment Group). Patients assigned to the treatment group will be transiently intubated for surfactant administration, extubated, and placed back on NCPAP of 6 cm H2O. Both groups will then be followed over time to determine which infants meet treatment failure criteria defined as: Treatment failure was defined a priori by either failure of adequate oxygenation or ventilation as follows: "1" FiO2 greater than 0.75 for more than 30 minutes to maintain SpO2 within the pre-established target ranges, "2" persistent or recurrent desaturation below 80% that did not respond to suctioning of the airways and PPV, "3" PCO2>65 mmHg and pH<7.22 on an arterial or capillary blood gas analysis, in association with increased work of breathing. Infants in the Treatment Group who cannot be extubated after their initial dose of surfactant because of clinical instability will be analyzed as treatment failures. Premature infants that meet treatment failure criteria on either arm will be intubated and placed on mechanical ventilation and given surfactant rescue doses according to the criteria of the participating institutions. Premature infants with respiratory distress syndrome who do not meet treatment failure criteria in both groups will remain on NCPAP until their respiratory failure improves.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Early NCPAP plus very early surfactant |
|
| 2 | Active Comparator | NCPAP alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very early surfactant and bubble NCPAP | Other | For patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O |
| Measure | Description | Time Frame |
|---|---|---|
| Need for mechanical ventilation | Death or discharge from the NICU |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal mortality | During hospitalization in the NICU | |
| Air leak syndrome | death or discharge from the NICU | |
| Oxygen dependency at 36 weeks post menstrual age |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mario A Rojas, MD, MPH | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana | Bogota | Cundinamarca | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17882265 | Background | Rojas MA, Lozano JM, Rojas MX; Colombian Neonatal Research Network. International collaborative research: a Colombian model that promotes infant health and research capacity. J Perinatol. 2007 Dec;27(12):738-43. doi: 10.1038/sj.jp.7211827. Epub 2007 Sep 20. | |
| 19117872 | Derived | Rojas MA, Lozano JM, Rojas MX, Laughon M, Bose CL, Rondon MA, Charry L, Bastidas JA, Perez LA, Rojas C, Ovalle O, Celis LA, Garcia-Harker J, Jaramillo ML; Colombian Neonatal Research Network. Very early surfactant without mandatory ventilation in premature infants treated with early continuous positive airway pressure: a randomized, controlled trial. Pediatrics. 2009 Jan;123(1):137-42. doi: 10.1542/peds.2007-3501. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010995 | Pleural Diseases |
Not provided
Not provided
| INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| bubble NCPAP | Other | Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria. |
|
| Death or discharge from the NICU |