Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)

NCT00636324 | Terminated Phase 2 DMC

• 1 other identifier: REB project # 07-047
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its application remain. Clinical indications vary greatly between institutions, especially when combined with varieties of systems, devices, and techniques available. One of the controversial aspects that needs to be clarified is the level of pressure which should be used. The objective of the study is to compare the effectiveness of two ranges of nCPAP pressure that are within the spectrum of current practice for post-extubation support in very preterm infants.

Conditions

Respiratory Insufficiency of Prematurity

Keywords

Respiratory distress syndrome; Preterm infants; Extubation failure; Pneumothorax; Lung injury; Airway pressure

Outcome Measures

Primary Outcomes (1)

• The rate of successful extubation within 72 hours of extubation

  within 72 hours after extubation

Secondary Outcomes (5)

• The rate of successful extubation within 7 days of extubation

  within 14 days after extubation

• Number of days on nCPAP

  within 14 days after extubation

• Occurrence of air leak syndrome

  within 14 days after extubation

• Occurrence of IVH grade 3 or 4

  within 14 days after extubation

• Occurrence of traumatized nasal septum

  within 14 days after extubation

Study Arms (2)

1

EXPERIMENTAL

Nasal CPAP, level of 7 to 9 cmH2O

Device: Nasal CPAP, level 7 to 9 cmH2O

2

ACTIVE COMPARATOR

Nasal CPAP, level 4 to 6 cmH2O

Device: Nasal CPAP, level 4 to 6 cmH2O

Interventions

Nasal CPAP, level 7 to 9 cmH2O DEVICE

Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation

Also known as: High pressure nCPAP, 7-9 cmH2O

1

Nasal CPAP, level 4 to 6 cmH2O DEVICE

Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation

Also known as: Low pressure CPAP, 4-6 cmH2O

2

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight 500 - 1,250 g
• On mechanical ventilation before 7 days of age
• First extubation before 14 days of age

You may not qualify if:

• Presence of lethal anomalies or upper airway abnormalities
• IVH, grade 3 or 4
• Neuromuscular disorders
• Receiving muscle relaxation at time of extubation
• Congenital heart disease, except for PDA
• GI problems resulting in a need to avoid gastric distension

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome; Pneumothorax; Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Giulherme M SantAnna, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2010
• Last Updated: February 10, 2009

Record last verified: 2009-02