Skip to main content
OpenTrials
Completed

NCT Number: NCT00556738

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Distress Syndrome, Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Pulmonary Atelectasis Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Néonatalogie - Maternité - Hôpital Pellegrin

Bordeaux, 33076, France

About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal Continuous Positive Airway Pressure ventilation

Procedure

Nasal Continuous Positive Airway Pressure ventilation

Intrapulmonary Percussive Ventilation

Procedure

Intrapulmonary Percussive Ventilation

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

    Time frame: Within the first 6 hours after birth

Secondary outcomes

  1. Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy

    Time frame: Within the first 72 hours after birth

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: HFPV

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 12, 2007
Registry last updated
May 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.