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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00125450
Other study ID # P030421
Secondary ID AOM 03123DGS 200
Status Completed
Phase N/A
First received July 29, 2005
Last updated May 26, 2008
Start date September 2004
Est. completion date February 2008

Study information

Verified date October 2006
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.


Description:

Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the majority of hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence against the effectiveness of chest physiotherapy with vibration and postural drainage techniques has been described but forced expiratory technique, as described in France, has never been evaluated.

The investigators hypothesised that forced expiratory technique was able to reduce the duration of respiratory distress.

Comparison(s): The investigators compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Months
Eligibility Inclusion Criteria:

- Child aged 15 days to 24 months

- First acute bronchiolitis

- Indication of hospitalisation

- One or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate > 60/min; pulse oxymetry < 95%; alimentary intake < 2/3 of the needs.

Exclusion Criteria:

- Prematurity (gestational age < 32 weeks)

- Brondysplasia

- Chronic lung disease or congenital heart disease

- Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU)

- 3 or more chest physiotherapy procedures since hospitalisation

- Parental refusal

- Any chest physiotherapy contra-indication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Chest Physiotherapy with Forced Expiratory Technique
Chest Physiotherapy with Forced Expiratory Technique
Nasopharyngeal Aspiration
Nasopharyngeal Aspiration

Locations

Country Name City State
France Jean Verdier Hospital Bondy
France Ambroise Paré Hospital Boulogne Billancourt
France Antoine Béclère Hospital - Pediatric Department Clamart
France Kremlin Bicetre Hospital Le Kremlin Bicetre
France Necker - Enfants Malades Hospital Paris
France Robert Debré Hospital Paris
France Trousseau Hospital Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Association des réseaux Bronchiolite

Country where clinical trial is conducted

France, 

References & Publications (1)

Perrotta C, Ortiz Z, Roque M. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004873. Review. Update in: Cochrane Database Syst Rev. 2007;(1):CD004873. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate obtention Yes
Secondary Safety of the forced expiratory technique during hospitalisation Yes
Secondary Comparison of pulse oxymetry before/after chest physiotherapy during hospitalisation Yes
Secondary Quality of Life Scale on discharge No
See also
  Status Clinical Trial Phase
Completed NCT00677729 - Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis Phase 2
Completed NCT01354561 - Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients N/A
Completed NCT01189149 - Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis N/A
Completed NCT00884429 - Effectiveness of Chest Physiotherapy in Infants With Acute Viral Bronchiolitis N/A

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