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

November 23, 2007 updated by: Colombian Neonatal Research Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: bubble NCPAP
Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach "yes or no" treatment failure criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Need for mechanical ventilation
Time Frame: Death or discharge from the NICU
Death or discharge from the NICU

Secondary Outcome Measures

Outcome Measure
Time Frame
Neonatal mortality
Time Frame: During hospitalization in the NICU
During hospitalization in the NICU
Air leak syndrome
Time Frame: death or discharge from the NICU
death or discharge from the NICU
Oxygen dependency at 36 weeks post menstrual age
Time Frame: Death or discharge from the NICU
Death or discharge from the NICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colombian Neonatal Research Network

Collaborators

Abbott
Fisher and Paykel Healthcare
Vanderbilt University School of Medicine
Pontificia Universidad Javeriana

Investigators

  • Principal Investigator: Mario A Rojas, MD, MPH, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 23, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

November 26, 2007

Last Update Submitted That Met QC Criteria

November 23, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ColombianCNRNCPAP trial
  • Abbott Laboratories Grant

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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