Very Early Surfactant and NCPAP for Premature Infants With RDS

NCT00563641 | Completed Phase 3 DMC

• 2 other identifiers: ColombianCNRNCPAP trialAbbott Laboratories Grant
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NCPAP; Very early surfactant

Outcome Measures

Primary Outcomes (1)

• Need for mechanical ventilation

  Death or discharge from the NICU

Secondary Outcomes (3)

• Neonatal mortality

  During hospitalization in the NICU

• Air leak syndrome

  death or discharge from the NICU

• Oxygen dependency at 36 weeks post menstrual age

  Death or discharge from the NICU

Study Arms (2)

1

EXPERIMENTAL

Early NCPAP plus very early surfactant

Other: Very early surfactant and bubble NCPAP

2

ACTIVE COMPARATOR

NCPAP alone

Other: bubble NCPAP

Interventions

Very early surfactant and bubble NCPAP 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

1

bubble NCPAP OTHER

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

2

Eligibility Criteria

• Age: 27 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colombian Neonatal Research Network: lead
• Pontificia Universidad Javeriana: collaborator
• Vanderbilt University School of Medicine: collaborator
• Abbott: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana

Bogota, Cundinamarca, Colombia

Location

Related Publications (2)

• 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.

  PMID: 17882265 BACKGROUND

• 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.

  PMID: 19117872 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pneumothorax

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pleural Diseases

Study Officials

• Mario A Rojas, MD, MPH

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 26, 2007
• Study Start: January 1, 2004
• Study Completion: December 1, 2006
• Last Updated: November 26, 2007

Record last verified: 2007-11

Locations

CO (1)