Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.

NCT01276821 | Completed Phase 4 Results DMC

• 1 other identifier: PEDSTUTHIOM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among children aged 6 weeks to 24 months with bronchiolitis.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; L-Epinephrine; 3% Hypertonic Saline; Clinical Severity Score

Outcome Measures

Primary Outcomes (1)

• Mean Change in Clinical Severity Score

  Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline. Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children. The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa. The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992). This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale.

  2 hours

Secondary Outcomes (5)

• Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation

  At the end of 2 hours

• Relapse Rate

  24 hours

• Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week

  7 days

• Missed Days of Work of Caregivers

  7 days

• Persistence of Cough at the End of 1 Week

  7 days

Other Outcomes (1)

• Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.

  2 hours

Study Arms (2)

Standard Treatment

PLACEBO COMPARATOR

L-Epinephrine and Normal Saline (0.9%)

Drug: L-Epinephrine and Normal Saline (0.9%)

Study Treatment

ACTIVE COMPARATOR

L-Epinephrine and Hypertonic Saline (3%)

Drug: L-Epinephrine and Hypertonic Saline (3%)

Interventions

L-Epinephrine and Normal Saline (0.9%) DRUG

1.5ml of 1:1,000 L-Epinephrine and 4 ml of 0.9% Normal Saline

Also known as: Nebulised Epinephrine in 0.9% Normal saline

Standard Treatment

L-Epinephrine and Hypertonic Saline (3%) DRUG

1.5ml of 1:1,000 L-Epinephrine and 4 ml of 3% Hypertonic Saline

Also known as: Nebulised Epinephrine in 3% Hypertonic Saline

Study Treatment

Eligibility Criteria

• Age: 6 Weeks - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 weeks to 24 Months.
• First episode of wheezing
• Fever, cough and watery nasal discharge

You may not qualify if:

• Any underlying cardiovascular disease.
• Prior wheezing.
• Clinical Severity Score \> 9.
• Atopic dermatitis, allergic rhinitis or asthma.
• Oxygen saturation (SpO2) \<85% on room air.
• Obtunded consciousness.
• Previous treatment with bronchodilators within 4 hours.
• Any steroid therapy within 48 Hours.

Sponsors & Collaborators

• Dr. Aayush Khanal, MD: lead

Study Sites (1)

Out Patient Department and Emergency Department, Kanti Children Hospital

Kathmandu, Bagmati Zone, 44600, Nepal

Location

Related Publications (1)

• Khanal A, Sharma A, Basnet S, Sharma PR, Gami FC. Nebulised hypertonic saline (3%) among children with mild to moderately severe bronchiolitis--a double blind randomized controlled trial. BMC Pediatr. 2015 Sep 10;15:115. doi: 10.1186/s12887-015-0434-4.

  PMID: 26357896 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution; Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hypertonic Solutions

Results Point of Contact

• Title: Dr. Aayush Khanal
• Organization: Department of Child Health, Tribhuvan University Teaching Hospital, Institute of Medicine.

aayush_khanal@yahoo.com

977-1-4421532

Study Officials

• Aayush Khanal, MD

  Department of Child Health , Institute of Medicine , Tribhuvan University Teaching Hospital.

  PRINCIPAL INVESTIGATOR

• Arun Sharma, MD

  Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine, Maharajgunj, Kathmandu ,Nepal.

  STUDY DIRECTOR

• Srijana Basnet, MD

  Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine , Maharajgunj , Kathmandu , Nepal.

  STUDY DIRECTOR

• Pushpa R Sharma, DCH,FCPS

  Head of the Department. Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine , Maharajgunj , Kathmandu , Nepal.

  STUDY CHAIR

• Fakir C Gami, MD

  Department of Child Health, Tribhuvan University Teaching Hospital, Institute of Medicine.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-04

Locations

NE (1)