Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

NCT03738501 | Completed DMC

• 1 other identifier: 2018-A01864-51
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine wether a single chest physiotherapy session with slow expiratory technique (SET) improves infants with viral bronchiolitis quality of life (food intake and sleep) on the next 24 hours.

Conditions

Acute Viral Bronchiolitis

Keywords

Food intake; Chest physiotherapy; Sleep; Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• Food ingestion

  Total Food ingestion within 24 hours after intervention measured by nurses or parents

  24 hours following intervention

Secondary Outcomes (6)

• Sleep quality

  24 hours following intervention

• Sleep quality

  24 hours following intervention

• Oxygen saturation

  Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

• Respiratory rate

  Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

• Heart Rate

  Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention

Study Arms (2)

Chest physiotherapy with SET

EXPERIMENTAL

Chest physiotherapy will be provided by a single physiotherapist not involved in outcomes assessment. Airway clearance technique will be Slow Expiratory Technique (SET). SET is a slow modulation of airflow in order to remove bronchial secretions within infants lungs. Experimental group will also benefit for standard medical and non-pharmacological care (e.g Standard Treatment)

Other: Chest physiotherapy with SET; Other: Standard Treatment

Standard treatment

ACTIVE COMPARATOR

Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices.

Other: Standard Treatment

Interventions

Chest physiotherapy with SET OTHER

Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)

Chest physiotherapy with SET

Standard Treatment OTHER

Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)

Chest physiotherapy with SET; Standard treatment

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children under 12 months
• hospitalized for bronchiolitis
• chest physiotherapy prescription
• bronchial obstruction confirmed by physician and respiratory physiotherapist
• children more than 1 year
• exclusive breastfeeding or enteral feeding
• prematurity (gestational age \< 35 weeks)
• cardiac, neurological and pulmonary comorbidity
• continuous oxygen supplementation or ventilatory support
• chest physiotherapy contraindications

You may not qualify if:

• side effects during chest physiotherapy : bradycardia \<100 bpm, oxygen saturation\<90%, general state alteration
• outing, oxygen supplementation or parenteral nutrition less than 24 hours after randomization
• chest physiotherapy cessation according to family request

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (1)

Groupe Hospitalier Du Havre

Le Havre, 76290, France

Location

Related Publications (5)

• Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.

  PMID: 25349312 BACKGROUND

• Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.

  PMID: 20927359 BACKGROUND

• Gajdos V, Beydon N, Bommenel L, Pellegrino B, de Pontual L, Bailleux S, Labrune P, Bouyer J. Inter-observer agreement between physicians, nurses, and respiratory therapists for respiratory clinical evaluation in bronchiolitis. Pediatr Pulmonol. 2009 Aug;44(8):754-62. doi: 10.1002/ppul.21016.

  PMID: 19598273 BACKGROUND

• Combret Y, Machefert M, Couet M, Bonnevie T, Gravier FE, Gillot T, Le Roux P, Hilfiker R, Medrinal C, Prieur G. Effect of a prolonged slow expiration technique on 24-h food intake in children hospitalized for moderate bronchiolitis: a randomized controlled trial. Ital J Pediatr. 2024 Sep 27;50(1):196. doi: 10.1186/s13052-024-01770-2.

  PMID: 39334411 DERIVED

• Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

  PMID: 37010196 DERIVED

MeSH Terms

Conditions

Dyspnea

Interventions

SET protein, human

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pascal Le Roux, MD

  Groupe Hospitalier du Havre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc, PhD Candidate

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: January 2, 2019
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)