Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn
HFPV
2 other identifiers
interventional
100
1 country
1
Brief Summary
During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 9, 2007
CompletedFirst Posted
Study publicly available on registry
November 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 13, 2010
May 1, 2010
2.1 years
November 9, 2007
May 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Within the first 6 hours after birth
Secondary Outcomes (1)
Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy
Within the first 72 hours after birth
Study Arms (2)
nHFPV
EXPERIMENTALIntrapulmonary Percussive Ventilation
nCPAP
ACTIVE COMPARATORNasal Continuous Positive Airway Pressure ventilation
Interventions
Nasal Continuous Positive Airway Pressure ventilation
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Thoracic retraction
- Congenital intrathoracic malformations
- Meconium aspiration
- Early neonatal infections with hemodynamic troubles
- Severe neonatal asphyxia
- Polymalformative syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Néonatalogie - Maternité - Hôpital Pellegrin
Bordeaux, 33076, France
Related Publications (1)
Dumas De La Roque E, Bertrand C, Tandonnet O, Rebola M, Roquand E, Renesme L, Elleau C. Nasal high frequency percussive ventilation versus nasal continuous positive airway pressure in transient tachypnea of the newborn: a pilot randomized controlled trial (NCT00556738). Pediatr Pulmonol. 2011 Mar;46(3):218-23. doi: 10.1002/ppul.21354. Epub 2010 Oct 20.
PMID: 20963833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clothilde Bertrand, Dr
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 9, 2007
First Posted
November 12, 2007
Study Start
November 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 13, 2010
Record last verified: 2010-05