Very Early Surfactant and NCPAP for Premature Infants With RDS

Respiratory Distress Syndrome Clinical Trial

— CNRNCPAP  

Official title:

Very Early Surfactant Without Mandatory Ventilation In Premature Infants Treated With Early Continuous Positive Airway Pressure-A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563641
• Other study ID #: ColombianCNRNCPAP trial
• Secondary ID: Abbott Laborator
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2007
• Last updated: November 23, 2007
• Start date: January 2004
• Est. completion date: December 2006

Study information

• Verified date: November 2007
• Source: Colombian Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia:Research Promotion Office. Academic Vice Rectory Pontificia Universidad Javeriana.
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 27 Weeks to 31 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lung Disease
• Lung Diseases
• Pneumothorax
• Pneumothorax/Pulmonary Intersticial Emphysema
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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
• bubble NCPAP
Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria.

Locations

Country	Name	City	State
Colombia	Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana	Bogota	Cundinamarca

Sponsors (5)

Lead Sponsor	Collaborator
Colombian Neonatal Research Network	Abbott, Fisher and Paykel Healthcare, Pontificia Universidad Javeriana, Vanderbilt University School of Medicine

Country where clinical trial is conducted

Colombia, 

References & Publications (1)

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. Epub 2007 Sep 20. Review. Erratum in: J Perinatol. 2007 Dec;27(12):808. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for mechanical ventilation		Death or discharge from the NICU
Secondary	Neonatal mortality		During hospitalization in the NICU
Secondary	Air leak syndrome		death or discharge from the NICU
Secondary	Oxygen dependency at 36 weeks post menstrual age		Death or discharge from the NICU

External Links

•   website for Pontificia Universidad Javeriana Research