Clinical trial NCT00636324: Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)
Official title: Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Insufficiency of Prematurity
Keywords: Respiratory distress syndrome
Preterm infants
Extubation failure
Pneumothorax
Lung injury
Airway pressure
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 23
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The use of nCPAP has been established as an effective respiratory support to prevent extubation failure and as treatment of other pulmonary diseases. An upsurge in its popularity has resulted in some controversial aspects, including the level of pressure to be used. The level that has been used in very preterm infants after extubation, which mostly came from anecdotal data, varies from 3 to 10 cmH2O.

Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though potential side effects have been of concern in practical application, there is no formal evidence supporting the concept that increased CPAP pressure results in a higher risk of complications. In relatively stable preterm infants, the range of optimal CPAP level needs to be established in order to adequately support the upper airway and lungs, without increasing complications secondary to the pressure applied. Given the uncertainty of the nCPAP pressure that should be used in very preterm infants, we conduct a randomized controlled trial to compare the effectiveness of two ranges of nCPAP pressure for post-extubation support in very preterm infants.

The purpose of this trial is to compare the rate of successful extubation of using the nasal CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The rate of successful extubation within 72 hours of extubation
timeFrame: within 72 hours after extubation
Secondary outcomes:
measure: The rate of successful extubation within 7 days of extubation
timeFrame: within 14 days after extubation
measure: Number of days on nCPAP
timeFrame: within 14 days after extubation
measure: Occurrence of air leak syndrome
timeFrame: within 14 days after extubation
measure: Occurrence of IVH grade 3 or 4
timeFrame: within 14 days after extubation
measure: Occurrence of traumatized nasal septum
timeFrame: within 14 days after extubation
Other outcomes:
Locations:
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Giulherme M SantAnna, MD
role: PRINCIPAL_INVESTIGATOR
References: