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Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis

NCT01619657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-10-26

No results posted yet for this study

Summary

The purpose of this study is to assess whether 6% hypertonic saline (HS) is a safe and effective preventive therapy in newborns and infants with cystic fibrosis (CF).

Conditions

  • Cystic Fibrosis Lung Disease

Interventions

DRUG

6% Hypertonic Saline (HS), 4mL

Administered via inhalation twice daily for 52 weeks. The delivery system is a PARI LC SPRINT® Junior nebulizer with a baby bend, size-adapted PARI® Baby face mask size 0-3, connection tubing (2.2m) and a PARI JuniorBOY® SX compressor.

DRUG

0.9% Isotonic Saline (IS), 4mL

Administered via inhalation twice daily for 52 weeks. The delivery system is a PARI LC SPRINT® Junior nebulizer with a baby bend, size-adapted PARI® Baby face mask size 0-3, connection tubing (2.2m) and a PARI JuniorBOY® SX compressor.

Sponsors & Collaborators

  • German Center for Lung Research

    collaborator OTHER

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Marcus A Mall, MD · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-11-30
Completion
2017-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01619657 on ClinicalTrials.gov