Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure
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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 |
- 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.
- 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 |
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 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:
|
Hyaline Membrane Disease Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 19, 2013