Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01093495
First received: March 24, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted

March 24, 2010
March 24, 2010
January 2009
December 2009   (final data collection date for primary outcome measure)
Duration of oxygen use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The number of days for oxygen use from the start of randomization until hospital discharge will be recorded.
Same as current
No Changes Posted
Length of respiratory support [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The number of days in which the subject requires any sort of respiratory support will be recorded, including: CPAP, nasal cannula and mechanical ventilation.
Same as current
Not Provided
Not Provided
 
Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure
A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Distress Syndrome
  • Hyaline Membrane Disease
  • Preterm Infants
  • Premature Infants
  • Device: CPAP
    CPAP
  • Device: Nasal Cannula
    Nasal Cannula
  • Experimental: CPAP group
    Subjects in this group will continue receiving CPAP until no oxygen requirement for 24 hours, then will be weaned off CPAP completely as long as they tolerate. CPAP will be re-instituted if subjects meet failing criteria. Another trial off CPAP will start 24 hours after failure and/or after being on 21% for 24 hours. CPAP will be weaned off directly to room air at all times.
    Intervention: Device: CPAP
  • Experimental: Nasal Cannula Group
    Subjects will be weaned from CPAP (when FiO2 <0.30) to Nasal cannula (2 L/min) with whatever FiO2 they need until they are off oxygen and NC completely. However, if these infants fail on NC they will be put back to nCPAP. Infants will then be maintained on CPAP until stable on CPAP-30% for 24 hours. Infants will be tried for another weaning using NC. So, infants assigned to NC will be weaned only through NC. CPAP will be used only for stabilization in between trials if needed.
    Intervention: Device: Nasal Cannula

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants born greater than or equal to 28 weeks (28+0) and less than 37 weeks (36+6) gestation
  • CPAP pressure of 5 cm H2O
  • FiO2 requirement = or <0.30
  • Clinically stable on these CPAP parameters for 24 hours pre-randomization:

    • Respiratory rate less than 60
    • No significant chest recession
    • No apnea requiring bagging and/or
    • Not more than 6 apneas requiring stimulation in the preceding 24 h.
    • Average saturation > or = 87%
    • Satisfactory ABG (pH> 7.25, PCO2 < 60, and Base deficit < -8)

Exclusion Criteria:

  • Life threatening congenital anomalies
  • Congenital cyanotic heart diseases
  • Congenital airway or chest wall abnormalities
  • Pulmonary hypoplasia
  • Known or suspected to have a neuromuscular disorder
  • Congenital neurological disorder, severe IVH (grade 3 or 4), PVL and hydrocephalus
Both
28 Weeks to 36 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01093495
20081230
Yes
Hesham Abdel Hady, Mansoura University Children's Hospital
Mansoura University
Not Provided
Principal Investigator: Hesham Abdel Hady, MD Mansoura University Children's Hospital
Mansoura University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP