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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00556738 |
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Date of registration:
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09/11/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn
HFPV |
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Scientific title:
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Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00556738 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Clothilde Bertrand, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Caesarean newborn
- Gestational age = 35 weeks
- Weight = 2 kg
- SaO2 < 90% after 10 min of life
- Silverman score = 5
- Treated less than 20 min after birth
- Social security affiliation (parents)
- Informed consent signed (parents)
Exclusion Criteria:
- Thoracic retraction
- Congenital intrathoracic malformations
- Meconium aspiration
- Early neonatal infections with hemodynamic troubles
- Severe neonatal asphyxia
- Polymalformative syndrome
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Respiratory Distress Syndrome, Newborn
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Intervention(s)
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Procedure: Intrapulmonary Percussive Ventilation
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Procedure: Nasal Continuous Positive Airway Pressure ventilation
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Primary Outcome(s)
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Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes
[Time Frame: Within the first 6 hours after birth]
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Secondary Outcome(s)
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Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy
[Time Frame: Within the first 72 hours after birth]
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Secondary ID(s)
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2007-A00666-47
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CHUBX 2007/09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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