Very Early Surfactant and NCPAP for Premature Infants With RDS (CNRNCPAP)
This study has been completed.
Sponsor:
Colombian Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT00563641
First Posted: November 26, 2007
Last Update Posted: November 26, 2007
Collaborators:
Pontificia Universidad Javeriana
Vanderbilt University School of Medicine
Abbott
Fisher and Paykel Healthcare
Information provided by:
Colombian Neonatal Research Network
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Respiratory Distress Syndrome Pneumothorax/Pulmonary Intersticial Emphysema Chronic Lung Disease | Other: Very early surfactant and bubble NCPAP Other: bubble NCPAP | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Very Early Surfactant Without Mandatory Ventilation In Premature Infants Treated With Early Continuous Positive Airway Pressure-A Randomized Controlled Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
primary spontaneous pneumothorax
Genetic and Rare Diseases Information Center resources:
Acute Respiratory Distress Syndrome
Respiratory Distress Syndrome, Infant
U.S. FDA Resources
Further study details as provided by Colombian Neonatal Research Network:
Primary Outcome Measures:
- Need for mechanical ventilation [ Time Frame: Death or discharge from the NICU ]
Secondary Outcome Measures:
- Neonatal mortality [ Time Frame: During hospitalization in the NICU ]
- Air leak syndrome [ Time Frame: death or discharge from the NICU ]
- Oxygen dependency at 36 weeks post menstrual age [ Time Frame: Death or discharge from the NICU ]
| Enrollment: | 278 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Early NCPAP plus very early surfactant
|
Other: Very early surfactant and bubble NCPAP
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
|
|
Active Comparator: 2
NCPAP alone
|
Other: bubble NCPAP
Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria.
|
Detailed Description:
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.
Eligibility
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| Ages Eligible for Study: | 27 Weeks to 31 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Gestational age of 27 to 31 6/7 weeks,
- Postnatal age between 15 and 60 minutes,
- Supplemental oxygen requirement or evidence of increased work of breathing (tachypnea, intercostal retractions, nasal flaring, or grunting), and
- Prenatal consent.
Exclusion Criteria:
- Apgar score less than 2 at 5 minutes,
- Intubation prior to randomization,
- Prenatal diagnosis of major congenital anomalies,
- Prolonged rupture of membranes of greater than 3 weeks duration, and
- Infants who were likely to be transferred to another center soon after birth were not enrolled in the study.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563641
Locations
| Colombia | |
| Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana | |
| Bogota, Cundinamarca, Colombia | |
Sponsors and Collaborators
Colombian Neonatal Research Network
Pontificia Universidad Javeriana
Vanderbilt University School of Medicine
Abbott
Fisher and Paykel Healthcare
Investigators
| Principal Investigator: | Mario A Rojas, MD, MPH | Vanderbilt University |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00563641 History of Changes |
| Other Study ID Numbers: |
ColombianCNRNCPAP trial Abbott Laboratories Grant |
| First Submitted: | November 23, 2007 |
| First Posted: | November 26, 2007 |
| Last Update Posted: | November 26, 2007 |
| Last Verified: | November 2007 |
Keywords provided by Colombian Neonatal Research Network:
|
NCPAP Very early surfactant |
Additional relevant MeSH terms:
|
Lung Diseases Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Emphysema Pneumothorax Respiratory Tract Diseases Respiration Disorders |
Infant, Premature, Diseases Infant, Newborn, Diseases Pathologic Processes Pleural Diseases Pulmonary Surfactants Respiratory System Agents |