Table 1 Summary of trial characteristics
Recruiting | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov Identifier: NCT04253951 |
Date of registration in primary registry | 05 February, 2020 |
Source(s) of monetary or material support | Italian Ministry of Health |
Primary sponsor | Italian Ministry of Health |
Contact for public queries | SF, MD, PHD simona.fiori@fsm.unipi.it |
Contact for scientific queries | SF, MD, PHD simona.fiori@fsm.unipi.it IRCCS Fondazione Stella Maris, Pisa, Italy |
Public title | LUNCH—Lung Ultrasound for early detection of silent and apparent aspiratioN in infants and young CHildren with cerebral palsy and other developmental disabilities: study protocol of a randomized controlled trial |
Scientific title | LUNCH—Lung Ultrasound for early detection of silent and apparent aspiratioN in infants and young CHildren with cerebral palsy and other developmental disabilities: study protocol of a randomized controlled trial |
Countries of recruitment | Italy |
Health condition(s) or problem(s) studied | Aspiration in pediatric cerebral palsy and developmental disabilities |
Health condition(s) or problem(s) studied | Active comparator: Lung ultrasound monitored management |
Standard care | |
Key inclusion and exclusion criteria | Ages eligible for study: 0–6 years Sexes eligible for study: both Accepts healthy volunteers: no |
Inclusion criteria: infant and children < 6 years; with, or at risk for, cerebral palsy or abnormal muscular tone due disorders other than cerebral palsy; suspicion of GERD or dysphagia based on clinical symptoms | |
Exclusion criteria: primary chronic lung diseases | |
Study type | Interventional |
Allocation: randomized intervention model. Double blind (caregiver, outcomes assessor) | |
Primary purpose: early diagnosis | |
Date of first enrolment | April 2021 |
Target sample size | 150 |
Recruitment status | Recruiting |