Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Hyaline Membrane Disease
Premature Birth
Premature Infants
Preterm Infants
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn

Clinical Trial Details

NCT number	NCT01093495
Study type	Interventional
Source	Mansoura University
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	January 2010

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.