Clinical trial NCT00563641: Very Early Surfactant and NCPAP for Premature Infants With RDS
Official title: Very Early Surfactant Without Mandatory Ventilation In Premature Infants Treated With Early Continuous Positive Airway Pressure-A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome
Pneumothorax/Pulmonary Intersticial Emphysema
Chronic Lung Disease
Keywords: NCPAP
Very early surfactant
Lead sponsor: Colombian Neonatal Research Network
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
name: Vanderbilt University School of Medicine
name: Abbott
name: Fisher and Paykel Healthcare
First posted: 2007-11-26
Enrollment: 278
Sex: ALL
Minimum age (years): 27
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Need for mechanical ventilation
timeFrame: Death or discharge from the NICU
Secondary outcomes:
measure: Neonatal mortality
timeFrame: During hospitalization in the NICU
measure: Air leak syndrome
timeFrame: death or discharge from the NICU
measure: Oxygen dependency at 36 weeks post menstrual age
timeFrame: Death or discharge from the NICU
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana
state: Cundinamarca
Study officials:
affiliation: Vanderbilt University
name: Mario A Rojas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.