Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn

Respiratory Distress Syndrome, Newborn Clinical Trial

— HFPV  

Official title:

Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556738
• Other study ID #: CHUBX 2007/09
• Secondary ID: 2007-A00666-47
• Status: Completed
• Phase: N/A
• First received: November 9, 2007
• Last updated: May 12, 2010
• Start date: November 2007
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Nasal Continuous Positive Airway Pressure ventilation
Nasal Continuous Positive Airway Pressure ventilation
• Intrapulmonary Percussive Ventilation
Intrapulmonary Percussive Ventilation

Locations

Country	Name	City	State
France	Néonatalogie - Maternité - Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy		Within the first 72 hours after birth	No