- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01093495
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt
- Mansoura University Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Nasal Cannula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hesham Abdel Hady, MD, Mansoura University Children's Hospital
Publications and helpful links
General Publications
- Ho JJ, Henderson-Smart DJ, Davis PG. Early versus delayed initiation of continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;2002(2):CD002975. doi: 10.1002/14651858.CD002975.
- Ho JJ, Subramaniam P, Henderson-Smart DJ, Davis PG. Continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;(2):CD002271. doi: 10.1002/14651858.CD002271.
- Aly H, Massaro AN, Patel K, El-Mohandes AA. Is it safer to intubate premature infants in the delivery room? Pediatrics. 2005 Jun;115(6):1660-5. doi: 10.1542/peds.2004-2493.
- Aly H, Massaro AN, Hammad TA, Narang S, Essers J. Early nasal continuous positive airway pressure and necrotizing enterocolitis in preterm infants. Pediatrics. 2009 Jul;124(1):205-10. doi: 10.1542/peds.2008-2588.
- Abdel-Hady H, Matter M, Hammad A, El-Refaay A, Aly H. Hemodynamic changes during weaning from nasal continuous positive airway pressure. Pediatrics. 2008 Nov;122(5):e1086-90. doi: 10.1542/peds.2008-1193. Erratum In: Pediatrics. 2009 Aug;124(2):847.
- Aly H. Is there a strategy for preventing bronchopulmonary dysplasia? Absence of evidence is not evidence of absence. Pediatrics. 2007 Apr;119(4):818-20. doi: 10.1542/peds.2006-3026. No abstract available.
- Aly H, Massaro AN, El-Mohandes AA. Can delivery room management impact the length of hospital stay in premature infants? J Perinatol. 2006 Oct;26(10):593-6. doi: 10.1038/sj.jp.7211575. Epub 2006 Jul 20.
- Aly H, Milner JD, Patel K, El-Mohandes AA. Does the experience with the use of nasal continuous positive airway pressure improve over time in extremely low birth weight infants? Pediatrics. 2004 Sep;114(3):697-702. doi: 10.1542/peds.2003-0572-L.
- Abdel-Hady H, Shouman B, Aly H. Early weaning from CPAP to high flow nasal cannula in preterm infants is associated with prolonged oxygen requirement: a randomized controlled trial. Early Hum Dev. 2011 Mar;87(3):205-8. doi: 10.1016/j.earlhumdev.2010.12.010. Epub 2011 Jan 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Premature Birth
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Hyaline Membrane Disease
Other Study ID Numbers
- 20081230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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