Evidence map›Paper›PMID 35739502›Full record

ArticleBMC pediatrics2022

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.

S Fiori, R T Scaramuzzo, E Moretti, C Amador, T Controzzi, A Martinelli, L Filippi, A Guzzetta, L Gargagni

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04253951 (Lung Ultrasound for Early Detection of Silent and Apparent aspiratioN in Infants and Young CHildren With Cerebral Palsy and Other Developmental Disabilities), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04253951 naunknown statusnot on this map

Lung Ultrasound for Early Detection of Silent and Apparent aspiratioN in Infants and Young CHildren With Cerebral Palsy and Other Developmental Disabilities: a New Fast, Safe, Cost-effective Infant-friendly Imaging Tool to Easily Monitor Feeding , Improve Outcomes and Reduce Morbidities (LUNCH)

TypeinterventionalSponsorIRCCS Fondazione Stella MarisRan2021 to 2023Enrolled150ConditionsCerebral Palsy, Pediatric Neurological Disorder, Developmental DisabilityArmsLung Ultrasound (LUS)-monitored feeding trial
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

S FioriDepartment of Developmental Neuroscience, Istituto Di Ricovero E Cura a Carattere Scientifico (IRCCS) Fondazione Stella Maris, Pisa, Italy. simona.fiori@fsm.unipi.it.
R T ScaramuzzoDepartment of Neonatal Intensive Care Unit, S. Chiara Hospital, Pisa, Italy.
E MorettiDepartment of Developmental Neuroscience, Istituto Di Ricovero E Cura a Carattere Scientifico (IRCCS) Fondazione Stella Maris, Pisa, Italy.
C AmadorDepartment of Developmental Neuroscience, Istituto Di Ricovero E Cura a Carattere Scientifico (IRCCS) Fondazione Stella Maris, Pisa, Italy.
T ControzziDepartment of Neonatal Intensive Care Unit, S. Chiara Hospital, Pisa, Italy.
A MartinelliDepartment of Developmental Neuroscience, Istituto Di Ricovero E Cura a Carattere Scientifico (IRCCS) Fondazione Stella Maris, Pisa, Italy.
L FilippiDepartment of Neonatal Intensive Care Unit, S. Chiara Hospital, Pisa, Italy.
A GuzzettaDepartment of Developmental Neuroscience, Istituto Di Ricovero E Cura a Carattere Scientifico (IRCCS) Fondazione Stella Maris, Pisa, Italy.
L GargagniInstitute of Clinical Physiology, National Research Council of Italy (CNR), Pisa, Italy.
Fondazione Stella Maris · ITOspedale Santa Chiara · ITNational Research Council · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren with neurological impairment may have dysphagia and/or gastro-esophageal reflux disease (GERD), which predispose to complications affecting the airways, increasing risk for aspiration-induced acute and chronic lung disease, or secondarily malnutrition, further neurodevelopmental disturbances, stressful interactions with their caregivers and chronic pain. Only multidisciplinary clinical feeding evaluation and empirical trials are applied to provide support to the management of feeding difficulties related to dysphagia or GERD, but no standardized feeding or behavioral measure exists at any age to assess aspiration risk and support the indication to perform a videofluoroscopic swallowing study (VFSS) or a fibre-optic endoscopic examination of swallowing (FEES), in particular in newborns and infants with neurological impairments. Lung ultrasound (LUS) has been proposed as a non-invasive, radiation-free tool for the diagnosis of pulmonary conditions in infants, with high sensitivity and specificity.

methodsA RCT will be conducted in infants aged between 0 and 6 years having, or being at risk for, cerebral palsy, or other neurodevelopmental disease that determines abnormal muscular tone or motor developmental delay assessed by a quantitative scale for infants or if there is the suspicion of GERD or dysphagia based on clinical symptoms. Infants will be allocated in one of 2 groups: 1) LUS-monitored management (LUS-m); 2) Standard care management (SC-m) and after baseline assessment (T0), both groups will undergo an experimental 6-months follow-up. In the first 3 months, infants will be evaluated a minimum of 1 time per month, in-hospital, for a total of 3 LUS-monitored meal evaluations. Primary and secondary endpoint measures will be collected at 3 and 6 months. DISCUSSION: This paper describes the study protocol consisting of a RCT with two main objectives: (1) to evaluate the benefits of the use of LUS for monitoring silent and apparent aspiration in the management of dysphagia and its impact on pulmonary illness and growth and (2) to investigate the impact of the LUS management on blood sample and bone metabolism, pain and interaction with caregivers.

trial registrationTrial registration date 02/05/2020; ClinicalTrials.gov Identifier: NCT04253951 .

Indexed as

Cerebral PalsyDeglutition DisordersDevelopmental DisabilitiesGastroesophageal RefluxChildChild, PreschoolHumansInfantInfant, NewbornLungRandomized Controlled Trials as TopicUltrasonographyAspirationDysphagiaGERDInfantLung ultrasound (LUS)Neurological impairment

Identifiers

PMID35739502
PMCPMC9219199
OpenAlexW4283330794

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.