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      Feasibility of Early Intervention Through Home-Based and Parent-Delivered Infant Massage in Infants at High Risk for Cerebral Palsy

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          Abstract

          Infant massage (IM) can be considered an early intervention program that leads to the environmental enrichment framework. The effectiveness of IM to promote neurodevelopment in preterm infants has been proved, but studies on infants with early brain damage are still lacking. The main aim of this study was to assess the feasibility, acceptability and usability of IM, carried out by parents at home, on infants at high risk for Cerebral Palsy. An IM daily diary and an ad hoc questionnaire, called Infant Massage Questionnaire Parent-Infant Experiences (IMQPE), were developed. IMQPE consisted of a total of 30 questions, divided into 5 areas. The parents were trained to carry out the IM with a home-based course, conducted by an expert therapist. The intensive IM program was set according to a defined daily length of at least 20 min, with a frequency of at least 5 days per week for a total of 8 weeks. Data collection consisted in the selection of the variables around the characteristics, both of the infants and the mothers, IM dosage and frequency, different body parts of the infants involved and IMQPE scores. Variable selection was carried out by minimizing the Bayesian Information Criteria (BIC) over all possible variable subsets. Nineteen high-risk infants, aged 4.83 ± 1.22 months, received IM at home for 8 weeks. The massage was given by the infants' mothers with a mean daily session dose of 27.79 ± 7.88 min and a total of 21.04 ± 8.49 h. 89.74% and 100% of mothers performed the IM for the minimum daily dosage and the frequency recommended, respectively. All the families filled in the IMQPE, with a Total mean score of 79.59% and of 82.22% in General Information on IM, 76.30% in Infant's intervention-related changes, 76.85% in IM Suitability, 79.07% in Infant's acceptance and 83.52% in Time required for the training. Different best predictors in mothers and in infants have been found. These data provide evidence of the feasibility of performing IM at home on infants at high risk for CP. Study registration: www.clinicaltrial.com (NCT03211533 and NCT03234959).

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          A tutorial on pilot studies: the what, why and how

          Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.
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            An update on the prevalence of cerebral palsy: a systematic review and meta-analysis.

            The aim of this study was to provide a comprehensive update on (1) the overall prevalence of cerebral palsy (CP); (2) the prevalence of CP in relation to birthweight; and (3) the prevalence of CP in relation to gestational age. A systematic review and meta-analysis was conducted and reported, based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) statement. Population-based studies on the prevalence of CP in children born in 1985 or after were selected. Statistical analysis was carried out using computer package R, version 2.14. A total of 49 studies were selected for this review. The pooled overall prevalence of CP was 2.11 per 1000 live births (95% confidence interval [CI] 1.98-2.25). The prevalence of CP stratified by gestational age group showed the highest pooled prevalence to be in children weighing 1000 to 1499g at birth (59.18 per 1000 live births; 95% CI 53.06-66.01), although there was no significant difference on pairwise meta-regression with children weighing less than 1000g. The prevalence of CP expressed by gestational age was highest in children born before 28 weeks' gestation (111.80 per 1000 live births; 95% CI 69.53-179.78; p<0.0327). The overall prevalence of CP has remained constant in recent years despite increased survival of at-risk preterm infants. © The Authors. Developmental Medicine & Child Neurology © 2013 Mac Keith Press.
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              Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment.

              Cerebral palsy describes the most common physical disability in childhood and occurs in 1 in 500 live births. Historically, the diagnosis has been made between age 12 and 24 months but now can be made before 6 months' corrected age.
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                Author and article information

                Contributors
                Journal
                Front Pediatr
                Front Pediatr
                Front. Pediatr.
                Frontiers in Pediatrics
                Frontiers Media S.A.
                2296-2360
                19 July 2021
                2021
                : 9
                : 673956
                Affiliations
                [1] 1Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris , Pisa, Italy
                [2] 2Tuscan Ph.D. Programme of Neuroscience, University of Florence , Florence, Italy
                [3] 3Department of Clinical and Experimental Medicine, University of Pisa , Pisa, Italy
                [4] 4Neonatal Intensive Care Unit, Pisa University Hospital Santa Chiara , Pisa, Italy
                [5] 5Division of Neonatology, Careggi University Hospital, University of Florence , Florence, Italy
                [6] 6Neonatal Intensive Care Unit, Children's Hospital A. Meyer , Florence, Italy
                Author notes

                Edited by: Marco Carotenuto, University of Campania Luigi Vanvitelli, Italy

                Reviewed by: Carlotta Spagnoli, Santa Maria Nuova Hospital, Italy; Maria Esposito, Università degli Studi della Campania Luigi Vanvitelli, Italy

                *Correspondence: Giuseppina Sgandurra g.sgandurra@ 123456fsm.unipi.it

                This article was submitted to Pediatric Neurology, a section of the journal Frontiers in Pediatrics

                †These authors have contributed equally to this work

                Article
                10.3389/fped.2021.673956
                8328146
                34350144
                13308a67-b064-4932-8608-c20c3dcfb64b
                Copyright © 2021 Menici, Antonelli, Beani, Mattiola, Giampietri, Martini, Rizzi, Cecchi, Cioni, Cioni, Sgandurra and Caretoy-R Consortium.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 28 February 2021
                : 21 May 2021
                Page count
                Figures: 2, Tables: 12, Equations: 0, References: 71, Pages: 13, Words: 10148
                Funding
                Funded by: Ministero della Salute 10.13039/501100003196
                Award ID: 5 X 1000 Health Research 2017
                Award ID: Grant RC2019
                Award ID: RF 2013-02358095
                Funded by: Università di Pisa 10.13039/501100007514
                Award ID: PRA_2018_71
                Categories
                Pediatrics
                Original Research

                infant massage,cerebral palsy,early intervention,home-based intervention,family-centered intervention

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