Very Early Surfactant and NCPAP for Premature Infants With RDS

NCT ID: NCT00563641

Last Updated: 2007-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2006-12-31

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.

Conditions

Respiratory Distress Syndrome; Pneumothorax/Pulmonary Intersticial Emphysema; Chronic Lung Disease

Keywords

NCPAP; Very early surfactant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Early NCPAP plus very early surfactant

Group Type: EXPERIMENTAL

Very early surfactant and bubble NCPAP

Intervention Type: OTHER

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

2

NCPAP alone

Group Type: ACTIVE_COMPARATOR

bubble NCPAP

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

bubble NCPAP

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 27 Weeks
• Maximum Eligible Age: 31 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Javeriana

OTHER

Sponsor Role: collaborator

Vanderbilt University School of Medicine

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Colombian Neonatal Research Network

OTHER

Sponsor Role: lead

Principal Investigators

Mario A Rojas, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana

Bogota, Cundinamarca, Colombia

Countries

Colombia

References

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.

Reference Type: BACKGROUND

PMID: 17882265 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19117872 (View on PubMed)

Other Identifiers

Abbott Laboratories Grant

Identifier Type: -

Identifier Source: secondary_id

ColombianCNRNCPAP trial

Identifier Type: -

Identifier Source: org_study_id