Clinical Trial: Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

Brief Summary:

There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP may be beneficial. On the other hand, removing CPAP too early may lead to complications that include: increasing apnea, increased oxygen requirement, increased work of breathing, the need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental study have demonstrated an improvement in lung growth after the prolonged use of CPAP.

Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of preterm infants. The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.

The purpose of this randomized controlled trial is to evaluate the clinical impact of two methods for weaning preterm infants from nCPAP.


Detailed Summary: The objective of this study is to test the null hypothesis that in preterm infants with gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen concentrations (FiO2) <0.30, keeping these infants on CPAP or changing them to NC flow of 1-2 L/min will not make any difference in length of hospitalization, length of respiratory support and incidence of complications.
Sponsor: Mansoura University

Current Primary Outcome: Duration of oxygen use [ Time Frame: 3 months ]

The number of days for oxygen use from the start of randomization until hospital discharge will be recorded.


Original Primary Outcome: Same as current

Current Secondary Outcome: Length of respiratory support [ Time Frame: 3 months ]

The number of days in which the subject requires any sort of respiratory support will be recorded, including: CPAP, nasal cannula and mechanical ventilation.


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: March 24, 2010
Date Started: January 2009
Date Completion:
Last Updated: March 24, 2010
Last Verified: March 2010