Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants

Bronchiolitis Clinical Trial

— BRONDUSAL  

Official title:

Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538458
• Other study ID #: 2014-A01335-42
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2015
• Last updated: November 2, 2017
• Start date: November 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

Description:

In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• 1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress

• Winter epidemic period from November, the 15th, to March the 15th

• Age < 12 months

• Admission Wang score included between 4 and 8

• Infant hospitalized for gravity clinical criteria of severity

• Nebulized 3 % hypertonic saline treatment since less than 24 hours

• Infant with social security card coverage

• Free consent of at least one of the parental authority holder

Exclusion Criteria:

• Pulmonary, cardiac or neurologic chronic underlying disease

• Prematurity < 32 GW

• Asthma (3rd episode or more)

• Admission oxygen saturation level < 85 %, Wang score = 9

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• 3 % hypertonic saline up to 72H
Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
• 3 % hypertonic saline up to 24H
Treatment by inhalation of 3 % hypertonic saline, up to 24H. followed by 48h of placebo : isotonic saline inhalation. Placebo control group.

Locations

Country	Name	City	State
France	Hôpital Couple Enfant	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wang score after 72 hours of treatment		72 hours
Secondary	Recovery time	Secondary outcomes will be assessed during the hospital stay for acute bronchiolitis, from inclusion date until day of hospital discharge, within 2 weeks.	From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Secondary	To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation	Percentage of patient needing transfer to the PICU or use of mechanical ventilation	From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Secondary	To assess average time of Oxygen therapy	average time of Oxygen therapy in days	From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Secondary	To assess average time of Tube feeding	average time of Tube feeding in days.	From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Secondary	To determine variation of Wang score during hospitalisation	Wang score,	measured at Day 1, 2, 3, 4 and day of discharge.
Secondary	To determine percentage of patient with Adverse Event	percentage of patient with Adverse Event	From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)