Very Early Surfactant and NCPAP for Premature Infants With RDS (CNRNCPAP)

This study has been completed.
Sponsor:
Collaborators:
Pontificia Universidad Javeriana
Vanderbilt University School of Medicine
Abbott
Fisher and Paykel Healthcare
Information provided by:
Colombian Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT00563641
First received: November 23, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:


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

Ages Eligible for Study:   27 Weeks to 31 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: November 23, 2007
Last Updated: November 23, 2007
Health Authority: Colombia:Research Promotion Office. Academic Vice Rectory Pontificia Universidad Javeriana.

Keywords provided by Colombian Neonatal Research Network:
NCPAP
Very early surfactant

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Newborn
Pneumothorax
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pleural Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014