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Note: This record shows only the 20 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.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00556738
Date of registration: 09/11/2007
Primary sponsor: University Hospital, Bordeaux
Public title: Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn HFPV
Scientific title: Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
Date of first enrolment: November 2007
Target sample size: 100
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00556738
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Respiratory Distress Syndrome, Newborn
Intervention(s)
Procedure: Intrapulmonary Percussive Ventilation
Procedure: Nasal Continuous Positive Airway Pressure ventilation
Primary Outcome(s)
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]
Secondary Outcome(s)
Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy [Time Frame: Within the first 72 hours after birth]
Secondary ID(s)
2007-A00666-47
CHUBX 2007/09
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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