Nebulised hypertonic saline (3 %) among children with mild to moderately severe bronchiolitis - a double blind randomized controlled trial

BMC Pediatrics

Fakir Chandra Gami¹  Pushpa Raj Sharma²  Srijana Basnet¹  Arun Sharma¹  Aayush Khanal¹ 

[1] Department of Pediatrics, Tribhuvan University Teaching Hospital, Institute of Medicine, Maharajgunj-44600, Kathmandu, Nepal;Kathmandu Medical College Teaching Hospital, Sinamangal, Kathmandu, Nepal

关键词: Hypertonic saline;    Epinephrine;    Clinical severity score;    Bronchiolitis;   

Others  :  1225259
DOI  :  10.1186/s12887-015-0434-4

 received in 2014-09-09, accepted in 2015-08-26,  发布年份 2015

【 摘 要 】

Background

To Assess the efficacy of nebulised hypertonic saline (HS) (3 %) among children with mild to moderately severe bronchiolitis.

Methods

Infants aged 6 weeks to 24 months, with a first episode of wheezing and Clinical Severity scores (Arch Dis Child 67:289-93, 1992) between 1 and 8, were enrolled over 4 months duration. Those with severe disease, co-morbidities, prior wheezing, recent bronchodilator and steroid use were excluded. Patients were randomized in a double-blind fashion, to receive two doses of nebulized 3 % HS (Group 1) or 0.9 % normal saline (Group 2) with 1.5 mg of L-Epineprine, delivered 30 min apart. Parents were contacted at 24 h and 7 days. The principal outcome measure was the mean change in clinical severity score at the end of 2 h of observation.

Results

A total of 100 infants (mean age 9.6 months, range 2–23 months; 61 % males) were enrolled. Patients in both groups had mild to moderately severe disease at presentation. On an intention-to-treat basis, the infants in the HS group had a significant reduction (3.57 ± 1.41) in the mean clinical severity score compared to those in the NS group (2.26 ± 1.15); [p < 0.001; CI: 0.78–1.82]. More children in the HS group (n = 35/50; 70.0 %) were eligible for ER/OPD discharge at the end of 2 h than those in the NS group (n = 15/50; 30 %; p < 0.001), and less likely to need a hospital re-visit (n = 5/50; 10.0 %) in the next 24 h as compared to the NS group (n = 15/50, 30.0 %; p < 0.001). The treatment was well tolerated, with no adverse effects.

Conclusions

Nebulized 3 % HS is effective, safe and superior to normal saline for outpatient management of infants with mild to moderately severe viral bronchiolitis in improving Clinical Severity Scores, facilitating early Out-Patient Department discharge and preventing hospital re-visits and admissions in the 24 h of presentation.

Trial registration

Clinicaltrials.gov NCTID012766821. Registered on January 12, 2011.

【 授权许可】

   
2015 Khanal et al.

【 图 表 】

Fig. 1.

Fig. 2.

【 参考文献 】

• [1]Chaudhary K, Sinert R. Is nebulized hypertonic saline solution an effective treatment for bronchiolitis in infants? Ann Emerg Med. 2010; 55:120-122.
• [2]Igor R, Tomaskovic L, Boschi-Pinto C, Campbell H. Global estimate of the incidence of clinical pneumonia among children under 5 years of age. Bull World Health Organ. 2004; 82:895-903.
• [3]Weber MW, Mulholland EK, Greenwood BM. Respiratory syncytial virus infection in tropical and developing countries. Trop Med Int Health. 1998; 3(4):268-80.
• [4]Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010; 125:342-349.
• [5]Behrendt CE, Decker MD, Burch DJ, Watson PH. International variation in the management of infants hospitalized with respiratory syncytial virus. International RSV Study Group. Eur J Pediatr. 1998; 157(3):215-220.
• [6]Christakis DA, Cowan CA, Garrison MM, Molteni R, Marcuse E, Zerr DM. Variation in inpatient diagnostic testing and management of bronchiolitis. Pediatrics. 2005; 115(4):878-884.
• [7]Willson DF, Horn SD, Hendley JO, Smout R, Gassaway J. Effect of practice variation on resource utilization in infants hospitalized for viral lower respiratory illness. Pediatrics. 2001; 108(4):851-5.
• [8]Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3 % saline in mild bronchiolitis. Pediatr Pulmonol. 2010; 45:41-47.
• [9]Wainwright C. Acute Viral Bronchiolitis in children- a very common condition with few therapeutic options. Paediatr Respir Rev. 2010; 11:39-45.
• [10]Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database of Syst Rev. 2013, Issue 7. Art. No.: CD006458. doi:10.1002/14651858.CD006458.pub3.
• [11]Al-Ansari K, Sakran M, Davidson BL, El Sayyed R, Mahjoub H, Ibrahim K. Nebulised 5 or 3 or 0.9 % saline for treating acute bronchiolitis in infants. J Pediatr. 2010; 157:630-4.
• [12]Mandelberg A, Amirav I. Hypertonic saline or high volume normal saline for viral bronchiolitis: mechanisms and rationale. Pediatr Pulmonol. 2010; 45:36-40.
• [13]Giudice M, Saitta F, Leonardi S. Effectiveness of nebulized hypertonic saline and epinephrine in hospitalized infants with bronchiolitis. Int J Immunopathol Pharmacol. 2012; 25(2):485-91.
• [14]Kuzik BA, Al Qadhi SA, Kent S. Nebulised hypertonic saline in the treatment of viral bronchiolitis 1 in infants. J Pediatr. 2007; 151:266-270.
• [15]Luo Z, Fu Z, Liu E. A randomized controlled trial of nebulised hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. J Clin Microbiol Inf. 2011; 17(12):1829-33.
• [16]Luo Z, Liu E, Luo J, Li S, Zeng F, Yang X et al.. Nebulized hypertonic saline/salbutamol solution treatment in hospitalized children with mild to moderate bronchiolitis. Pediatr Int. 2010; 52(2):199-202.
• [17]Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A et al.. Nebulised 3 % hypertonic saline solution treatment for hospitalized infants with bronchiolitis. Chest. 2003; 123:483-487.
• [18]Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA et al.. Nebulised 3 % hypertonic saline solution for treatment of ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002; 122:2015-2020.
• [19]Tal G, Cesar K, Oron A. Hypertonic saline/ epinephrine treatment in hospitalized infants with viral bronchiolitis reduces hospitalization stay: 2 years experience. IMAJ. 2006; 8:169-173.
• [20]Ipek IO, Yalchin EU, Sezer RG, Bozaykut A. The efficacy of nebulized salbutamol, hypertonic saline and salbutamol/hypertonic saline combination in moderate bronchiolitis. Pulm Pharmacol Ther. 2011; 24(6):633-7.
• [21]Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulised 3 % hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009; 163(11):1007-1012.
• [22]Florin TA, Shaw KN, Kittick M, Yaskscoe S, Zorc JJ. Nebulized hypertonic saline for bronchiolitis in the emergency department: a randomized clinical trial. 1. JAMA Pediatr. 2014; 168(7):664-702.
• [23]Teunissen J, Hochs AH, Vaessen-Verberne A, Boehmer AL, Smeets CC, Brackel H et al.. The effect of 3 and 6 % hypertonic saline in viral bronchiolitis: a randomised controlled trial. Eur Respir J. 2014; 44(4):913-21.
• [24]Wu S, Baker C, Lang ME. Nebulized hypertonic saline for bronchiolitis: a randomized controlled trial. JAMA Pediatr. 2014; 168(7):657-663.
• [25]Jacobs J, Foster M, Wan J, Pershad J. 7 % hypertonic saline in acute bronchiolitis: a randomized controlled trial. Pediatrics. 2014; 133:e8.
• [26]Wang EE, Milner R, Allen U, Maj H. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial. Arch Dis Child. 1992; 67:289-293.
• [27]Diagnosis and management of bronchiolitis. Pediatrics. 2006; 118:1774-1793.
• [28]Saghaei M. Random allocation software for parallel group randomised trials. BMC Med Res Methodol. 2004; 4:26. BioMed Central Full Text
• [29]Schultz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. BMJ. 2010; 340:c332.
• [30]Ralston S, Hill V, Martinez M. Nebulised hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010; 126:e520-e525.