Very Early Surfactant and NCPAP for Premature Infants With RDS

Phase

Condition

Chest Trauma

Lung Injury

Emphysema

Treatment

N/A

Clinical Study ID

NCT00563641

ColombianCNRNCPAP trial

Abbott Laboratories Grant

Ages 27-31
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 notenrolled in the study.

Study Design

January 01, 2004

December 31, 2006

Study 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.

Connect with a study center

Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana
Bogota, Cundinamarca
Colombia
Site Not Available

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