Chest Physiotherapy Technique Increasing Inspiratory Flow on Weaning From Non Invasive Ventilation

NCT02041676 | Completed

• 2 other identifiers: K 110701A0007936
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to show by a randomised controled therapeutic trial comparing in two parallel open arms ( 50 infants x 2 = 100 infants) that the technique IIF decreases the duration of non invasive respiratory support in the group treated by chest physiotherapy as compared to the control group. The secondary objectives are to evaluate the duration of oxygen dependence, the duration of hospitalisation and the proportional advent of bronchopulmonary dysplasia. These study will be conducted in patients less than 32 weeks post menstrual age, eutrophic, treated by non invasive respiratory support after weaning off from mechanical endotracheal ventilation benefitting form a social security system and for whom the appropriate parental authority are non opposed.

Conditions

Neonatal Respiratory Distress Syndrome; Intubation, Intratracheal

Keywords

Chest; Physiotherapy; Increased Inspiratory Flow Technique; Prematurity; Non Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Number of days of non invasive respiratory support post extubation

  Data noted till discharge from special care (baby ) unit (4 months)

Secondary Outcomes (4)

• Duration of oxygen dependence.

  Data noted till discharge from special care (baby ) unit (4 months)

• Duration of hospitalisation of the premature infant on the special care unit

  4 months

• bronchopulmonary dysplasia as established by the WALSH test as well as the presence of atelectasis on the chest X ray done within the 7 days following extubation

  at 36 weeks post menstrual age

• Pain score realised during the session

  until 4 months

Study Arms (2)

1: chest physiotherapy technique

EXPERIMENTAL

Chest physiotherapy technique increasing inspiratory flow (IIF) 3 times per day

Procedure: Chest physiotherapy

2: Usual surveillance

ACTIVE COMPARATOR

Usual surveillance of the non invasive ventilation

Procedure: Usual surveillance

Interventions

Chest physiotherapy PROCEDURE

Also known as: Increased inspiratory flow technique (IIF)

1: chest physiotherapy technique

Usual surveillance PROCEDURE

Usual surveillance of the non invasive ventilation without chest physiotherapy.

2: Usual surveillance

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \< 32 weeks post menstrual age (corrected gestational age) and eutrophic on the AUDIPOG charts
• Patients with non invasive ventilation/ respiratory support following weaning from mechanical endo tracheal ventilation.
• Information letter given to the appropriate parental authority.
• Prior medical evaluation.
• Affiliation with a social security system.

You may not qualify if:

• Pneumothorax, emphysema, reintubation within 24 hours.
• Small for gestational age as defined by a birth weight \< 10th percentile on the AUDIPOG charts.
• Intraventricular hemorrhage grade 3 and 4 (VOLPE's classification- (32-33))
• Thrombopenia (Platelet count \< 80 000/mm3)
• Malformative syndromes

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Antoine Béclère Hospital

Clamart, 92141, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Bruno Demont

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

• Camille Roussel, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 5, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)