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Randomized Controlled Trial
. 2017 Jul 15;43(1):60.
doi: 10.1186/s13052-017-0376-6.

Effects of inhaled hypertonic (7%) saline on lung function test in preschool children with cystic fibrosis: results of a crossover, randomized clinical trial

Raffaella Nenna  1 , Fabio Midulla  2 , Caterina Lambiase  2 , Giovanna De Castro  2 , Anna Maria Zicari  2 , Luciana Indinnimeo  2 , Giuseppe Cimino  3 , Patrizia Troiani  3 , Serena Quattrucci  3 , Giancarlo Tancredi  2
Affiliations
Randomized Controlled Trial

Effects of inhaled hypertonic (7%) saline on lung function test in preschool children with cystic fibrosis: results of a crossover, randomized clinical trial

Raffaella Nenna et al. Ital J Pediatr. .

Abstract

Background: This crossover, randomized, double-blind study (conducted over a 32-week period) was performed to determine, in clinically stable Cystic fibrosis (CF) preschool children: the effects of 7% inhaled hypertonic saline on spirometry and interrupter resistance technique (Rint), and the possible side effects.

Methods: Twelve CF children (6M, mean age ± SD: 5.7 ± 0.8 yrs) were enrolled and randomly assigned to receive hypertonic saline (HS-4 ml 7% sodium chloride), or normal saline (NS-0.9% sodium chloride) twice a day. After a 16 weeks period, therapy was exchanged to allow all the patients enrolled in the study to carry out both treatments. Monitoring visits, spirometry (COSMED Quark PFT4 ergo) and Rint were scheduled at 0,4,16,20,32 weeks. At T0, spirometric measurements and Rint were performed immediately before and 30 min after the inhalation therapy. Salbutamol (400 mcg) was administered before the drug at each visit.

Results: After a 16-weeks treatment with HS an improvement of FVC (p = 0.02) and a favorable trend of FEV1 were registered. A worsening of FEV1 (p < 0.0001) and of FEF25-75 (p = 0.019) were found in NS group. No differences were found in expiratory and inspiratory Rint in both groups. No serious adverse events occurred.

Conclusions: Seven percent hypertonic saline therapy proved to be a useful and safe treatment in young CF children with clinically stable conditions.

Trial registration: ISRCTN12345678 .

Keywords: Children; Cystic fibrosis; Hypertonic saline; Inhalation; Therapy.

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Conflict of interest statement

Ethics approval and consent to participate

All parents of children gave written informed consent and the protocol (prot. HS-2009) was approved by the Scientific Ethics Committee, Policlinico Umberto I.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design: weeks and visits in the two groups of children
Fig. 2
Fig. 2
Individual changes in in FVC (L), FEV1 (L) and FEF25-75 (L/s) at the baseline (T0), at T4 and T16 for HS (a) and NS (b) groups of children
See this image and copyright information in PMC

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