Very Early Surfactant and NCPAP for Premature Infants With RDS (CNRNCPAP)
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ClinicalTrials.gov Identifier: NCT00563641 |
Recruitment Status
:
Completed
First Posted
: November 26, 2007
Last Update Posted
: November 26, 2007
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 278 participants |
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 |
Study Start Date : | January 2004 |
Actual Study Completion Date : | December 2006 |

Arm | Intervention/treatment |
---|---|
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
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Other: bubble NCPAP
Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria.
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- Need for mechanical ventilation [ Time Frame: Death or discharge from the NICU ]
- 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 ]

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Ages Eligible for Study: | 27 Weeks to 31 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Colombia | |
Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana | |
Bogota, Cundinamarca, Colombia |
Principal Investigator: | Mario A Rojas, MD, MPH | Vanderbilt University |
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 Posted: | November 26, 2007 Key Record Dates |
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 |