Clinical trial NCT00556738: Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn
Official title: Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: HFPV
neonatal respiratory distress
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: * Principal Objective: To show that IPV ventilation can decrease the duration of transient respiratory distress as well as the risk of complications.
* Secondary Objective: Comparison between the two groups regarding: Length of oxygen therapy, complications (pneumothorax, pulmonary infections), need for intensive care hospitalization
* Study design: Open, prospective randomized trial.
* Inclusion criteria: Neonates with gestational age ≥ 35 weeks and weight ≥ 2000g, caesarean section, respiratory distress syndrome (modified Silverman score \> 5, SpO2 \< 90%), management within 20 minutes after birth.
* Exclusion criteria: clinical thoracic retraction, congenital lung malformation, meconium aspiration, neonatal infection, other congenital malformations.
* Study plan: After the screening evaluation and written consent document, neonates will be randomized into two groups: nCPAP ventilation or IPV. During the 6 hours after randomization, clinical data will be monitored: cardiac and respiratory frequency (CF -RF), saturation (SaO2), oxygenotherapy, Silverman Score. Then, neonates will be supervised 3 days after normalization of the respiratory distress.
* Number of subjects: 100 (50 in each group)

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Within the first 6 hours after birth
Secondary outcomes:
measure: Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy
timeFrame: Within the first 72 hours after birth
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Néonatalogie - Maternité - Hôpital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Clothilde Bertrand, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.