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