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
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome
Hyaline Membrane Disease
Preterm Infants
Premature Infants
Device: CPAP
Device: Nasal Cannula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: CPAP
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.
Device: Nasal Cannula
Nasal Cannula

Detailed 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.

  Eligibility

Ages Eligible for Study:   28 Weeks to 36 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093495

Locations
Egypt
Mansoura University Children's Hospital
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Hesham Abdel Hady, MD Mansoura University Children's Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hesham Abdel Hady, Mansoura University Children's Hospital
ClinicalTrials.gov Identifier: NCT01093495     History of Changes
Other Study ID Numbers: 20081230
Study First Received: March 24, 2010
Last Updated: March 24, 2010
Health Authority: Egypt: Minstery of Health and Population

Keywords provided by Mansoura University:
Nasal Continuous positive Airway pressure
Nasal Cannula
CPAP
Premature
RDS
HMD
NICU

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Hyaline Membrane Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014