{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T15:06:41Z","timestamp":1787065601392,"version":"build-2736575974"},"reference-count":41,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T00:00:00Z","timestamp":1714003200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002322","name":"Coordination for the Improvement of Higher Education Personnel","doi-asserted-by":"publisher","award":["001"],"award-info":[{"award-number":["001"]}],"id":[{"id":"10.13039\/501100002322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["IJERPH"],"abstract":"<jats:p>There is still very limited evidence on the effects of neonatal interventions on infant neurodevelopmental outcomes, including general movements (GMs). This research will primarily assess the effects of a sensory motor physical therapy intervention combined with kangaroo skin-to-skin contact on the GMs of hospitalized preterm newborns. Secondary outcomes include body weight, posture and muscle tone, behavioral state, length of hospital stay, and breastfeeding. This study protocol details a two-arm parallel clinical trial methodology, involving participants with a postmenstrual age of 34\u201335 weeks admitted to a Neonatal Intermediate Care Unit (NInCU) with poor repertoire GMs. Thirty-four participants will be randomly assigned to either the experimental group, receiving a 10-day sensory motor physical therapy associated with kangaroo skin-to-skin contact, or the control group, which will only receive kangaroo skin-to-skin contact. The study will measure GMs (primary outcome), and body weight, posture and muscle tone, behavioral state, length of hospital stay, and breastfeeding (secondary outcomes). Data collection occurs in the NInCU before and after the intervention, with follow-up measurements post discharge at 2\u20134 weeks and 12\u201315 weeks post-term. SPSS will be used for data analyses. The results will provide novel information on how sensory motor experiences may affect early neurodevelopment and clinical variables in preterm newborns.<\/jats:p>","DOI":"10.3390\/ijerph21050538","type":"journal-article","created":{"date-parts":[[2024,4,26]],"date-time":"2024-04-26T08:18:27Z","timestamp":1714119507000},"page":"538","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Randomized Controlled Trial Protocol on the Effects of a Sensory Motor Intervention Associated with Kangaroo Skin-to-Skin Contact in Preterm Newborns"],"prefix":"10.3390","volume":"21","author":[{"given":"Mariane de Oliveira Nunes","family":"Reco","sequence":"first","affiliation":[{"name":"Graduate Program in Health and Development, Faculty of Medicine, Federal University of Mato Grosso do Sul, Campo Grande 79070-900, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5354-5456","authenticated-orcid":false,"given":"Daniele Almeida","family":"Soares-Marangoni","sequence":"additional","affiliation":[{"name":"Graduate Program in Movement Sciences, Institute of Health, Federal University of Mato Grosso do Sul, Campo Grande 79070-900, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,4,25]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2023). Born Too Soon: Decade of Action on Preterm Birth, World Health Organization. Available online: https:\/\/www.who.int\/publications\/i\/item\/9789240073890."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1016\/j.clp.2022.10.004","article-title":"Efficacy of therapist supported interventions from the neonatal intensive care unit to home: A meta-review of systematic reviews","volume":"50","author":"McCarty","year":"2023","journal-title":"Clin. Perinatol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1111\/dmcn.14485","article-title":"Effect of neonatal therapy on the motor, cognitive, and behavioral development of infants born preterm: A systematic review","volume":"62","author":"Khurana","year":"2020","journal-title":"Dev. Med. Child Neurol."},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Soleimani, F., Azari, N., Ghiasvand, H., Shahrokhi, A., Rahmani, N., and Fatollahierad, S. (2020). Do NICU developmental care improve cognitive and motor outcomes for preterm infants? A systematic review and meta-analysis. BMC Pediatr., 20.","DOI":"10.1186\/s12887-020-1953-1"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1016\/S0378-3782(97)00092-3","article-title":"The qualitative assessment of general movements in preterm, term and young infants\u2014Review of the methodology","volume":"50","author":"Einspieler","year":"1997","journal-title":"Early Hum. Dev."},{"key":"ref_6","first-page":"1","article-title":"Prechtl\u2019s method on the qualitative assessment of general movements in preterm, term and young infants","volume":"167","author":"Einspieler","year":"2004","journal-title":"Clin. Dev. Med."},{"key":"ref_7","first-page":"CD005495","article-title":"Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants","volume":"2015","author":"Spittle","year":"2015","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"897","DOI":"10.1001\/jamapediatrics.2017.1689","article-title":"Early, accurate diagnosis and early intervention in cerebral palsy: Advances in diagnosis and treatment","volume":"171","author":"Novak","year":"2017","journal-title":"JAMA Pediatr."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"418","DOI":"10.1111\/dmcn.12140","article-title":"A systematic review of tests to predict cerebral palsy in young children","volume":"55","author":"Bosanquet","year":"2013","journal-title":"Dev. Med. Child Neurol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1111\/dmcn.14730","article-title":"Clinical tool used in young infants born very preterm to predict motor and cognitive delay (not cerebral palsy): A systematic review","volume":"4","author":"Caesar","year":"2021","journal-title":"Dev. Med. Child Neurol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1002\/mrdd.20051","article-title":"Prechtl\u2019s assessment of general movements: A diagnostic tool for the functional assessment of the young nervous system","volume":"11","author":"Einspieler","year":"2005","journal-title":"Ment. Retard. Dev. Disabil. Res. Rev."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"S64","DOI":"10.1016\/j.jped.2015.12.003","article-title":"Fidgety movements\u2014Tiny in appearance, but huge in impact","volume":"92","author":"Einspieler","year":"2016","journal-title":"J. Pediatr."},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Einspieler, C., Bos, A.F., Krieber-Tomantschger, M., Alvarado, E., Barbosa, V.M., Bertoncelli, N., Burger, M., Chorna, O., Del Secco, S., and DeRegnier, R. (2019). Cerebral Palsy: Early markers of clinical phenotype and functional outcome. J. Clin. Med., 8.","DOI":"10.3390\/jcm8101616"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"587","DOI":"10.1007\/s10882-019-09707-y","article-title":"Movement Imitation Therapy for Preterm Babies (MIT-PB): A novel approach to improve the neurodevelopmental outcome of infants at high-risk for cerebral palsy","volume":"32","author":"Soloveichick","year":"2020","journal-title":"J. Dev. Phys. Disabil."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"105197","DOI":"10.1016\/j.earlhumdev.2020.105197","article-title":"Early intervention and its short-term effect on the temporal organization of fidgety movements","volume":"151","author":"Adde","year":"2020","journal-title":"Early Hum. Dev."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Raith, W., Marschik, P.B., Sommer, C., Maurer-Fellbaum, U., Amhofer, C., Avian, A., L\u00f6wenstein, E., Soral, S., M\u00fcller, W., and Einspieler, C. (2016). General Movements in preterm infants undergoing craniosacral therapy: A randomised controlled pilot-trial. BMC Complement. Altern. Med., 16.","DOI":"10.1186\/s12906-016-0984-5"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/j.earlhumdev.2017.06.008","article-title":"Does a parent-administrated early motor intervention influence general movements and movement character at 3months of age in infants born preterm?","volume":"112","author":"Ustad","year":"2017","journal-title":"Early Hum. Dev."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"105488","DOI":"10.1016\/j.earlhumdev.2021.105488","article-title":"General movement optimality score and general movements trajectories following early parent-administrated physiotherapy in the neonatal intensive care unit","volume":"163","author":"Ustad","year":"2021","journal-title":"Early Hum. Dev."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1016\/j.braindev.2014.07.002","article-title":"Effect of early intervention on premature infants\u2019 general movements","volume":"37","author":"Ma","year":"2015","journal-title":"Brain Dev."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1097\/00005237-200206000-00007","article-title":"Musculoskeletal implications of preterm infant positioning in the NICU","volume":"16","author":"Sweeney","year":"2002","journal-title":"J. Perinat. Neonatal Nurs."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1016\/j.ejpn.2003.10.001","article-title":"Effect of positioning on the incidence of abnormalities of muscle tone in low-risk, preterm infants","volume":"8","author":"Ennouri","year":"2004","journal-title":"Eur. J. Paediatr. Neurol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"765","DOI":"10.1007\/s13312-013-0221-y","article-title":"Early developmental care interventions of preterm very low birth weight infants","volume":"50","author":"Ramachandran","year":"2013","journal-title":"Indian Pediatr."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1038\/jp.2008.229","article-title":"Early interventions involving parents to improve neurodevelopmental outcomes of premature infants: A meta-analysis","volume":"29","author":"Vanderveen","year":"2009","journal-title":"J. Perinatol."},{"key":"ref_24","first-page":"12","article-title":"First Brazilian recommendation on physiotherapy with sensory motor stimulation in newborns and infants in the intensive care unit","volume":"33","author":"Johnston","year":"2021","journal-title":"Rev. Bras. Ter. Intensiv."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1038\/jp.2016.179","article-title":"Enhancing sensory experiences for very preterm infants in the NICU: An integrative review","volume":"37","author":"Pineda","year":"2017","journal-title":"J. Perinatol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"e10","DOI":"10.1016\/j.pedn.2017.02.006","article-title":"The impact of kangaroo care on premature infant weight gain","volume":"34","author":"Evereklian","year":"2017","journal-title":"J. Pediatr. Nurs."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/j.jped.2021.06.004","article-title":"The effectiveness of Kangaroo Mother Care in hospitalization period of preterm and low birth weight infants: Systematic review and meta-analysis","volume":"98","author":"Narciso","year":"2022","journal-title":"J. Pediatr."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"639","DOI":"10.1002\/jdn.10216","article-title":"Skin-to-skin contact to support preterm infants and reduce NICU-related stress","volume":"82","author":"Pavlyshyn","year":"2022","journal-title":"Int. J. Dev. Neurosci."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"942","DOI":"10.1111\/apa.16695","article-title":"Cortical activation and oxygen perfusion in preterm newborns during kangaroo mother care: A pilot study","volume":"112","author":"Bembich","year":"2023","journal-title":"Acta Paediatr."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"2310","DOI":"10.1111\/apa.15913","article-title":"Systematic review confirmed the benefits of early skin-to-skin contact but highlighted lack of studies on very and extremely preterm infants","volume":"110","author":"Gupta","year":"2021","journal-title":"Acta Paediatr."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"1633","DOI":"10.1111\/apa.16842","article-title":"Skin-to-skin contact after birth: Developing a research and practice guideline","volume":"112","author":"Brimdyr","year":"2023","journal-title":"Acta Paediatr."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"350","DOI":"10.1590\/1809-2950\/21026629042022pt","article-title":"Physiotherapeutic performance in neonatal intensive care units in Rio Grande do Sul","volume":"29","author":"Amaral","year":"2022","journal-title":"Fisioter. Pesqui."},{"key":"ref_33","unstructured":"Gon\u00e7alves, M.C.P. (2012). Prematuridade: Desenvolvimento Neurol\u00f3gico e Motor: Avalia\u00e7\u00e3o e Tratamento. [Prematurity: Neurological and Motor Development: Evaluation and Treatment], Revinter. (In Portuguese)."},{"key":"ref_34","unstructured":"Sarmento, G.J.V. (2009). Bases do M\u00e9todo Reequil\u00edbrio T\u00f3raco-Abdominal. [Bases of the Thoraco-Abdominal Rebalancing Method]. O ABC da Fisioterapia Respirat\u00f3ria, Manole. (In Portuguese)."},{"key":"ref_35","unstructured":"Sarmento, G.J.V., Carvalho, F.A., and Peixe, A.A. (2011). Estimula\u00e7\u00e3o sens\u00f3rio-motora no rec\u00e9m-nascido. [Sensory motor stimulation in the newborn]. Fisioterapia Respirat\u00f3ria em Pediatria e Neonatologia, Manole. [2nd ed.]. (In Portuguese)."},{"key":"ref_36","unstructured":"Brazilian Ministry of Health (2023, June 26). Aten\u00e7\u00e3o Humanizada ao Rec\u00e9m-Nascido de Baixo Peso: M\u00e9todo Canguru\u2014Manual T\u00e9cnico [Humanized Care for Low Birth Weight Newborns: Kangaroo Method\u2014Technical Manual], Available online: https:\/\/bvsms.saude.gov.br\/bvs\/publicacoes\/atencao_humanizada_metodo_canguru_manual_3ed.pdf."},{"key":"ref_37","unstructured":"National Institutes of Health (2022, July 07). Medline Plus: Neonatal Weight Gain and Nutrition, Available online: https:\/\/medlineplus.gov\/ency\/article\/007302.htm."},{"key":"ref_38","unstructured":"Dubowitz, L.M.S., Dubowitz, V., and Mercuri, E. (1999). The Neurological Assessment of the Preterm and Full-Term Newborn Infant, Clinics in Developmental Medicine No. 148; Mac Keith Press."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/S0045-9380(76)80013-8","article-title":"Importance of behavioral assessment of the neonate","volume":"7","author":"Brazelton","year":"1976","journal-title":"Curr. Probl. Pediatr."},{"key":"ref_40","first-page":"1","article-title":"A controlled clinical trial of effects of water mist on obstructive respiratory signs, death rate and necropsy findings among premature infants","volume":"17","author":"Silverman","year":"1956","journal-title":"Pediatrics"},{"key":"ref_41","unstructured":"Twisk, J.W.R. (2003). Applied Longitudinal Data Analysis for Epidemiology: A Practical Guide, Cambridge University Press."}],"updated-by":[{"DOI":"10.3390\/ijerph21081028","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T00:00:00Z","timestamp":1714003200000}}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/21\/5\/538\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,3]],"date-time":"2025-08-03T14:33:42Z","timestamp":1754231622000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/21\/5\/538"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,25]]},"references-count":41,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2024,5]]}},"alternative-id":["ijerph21050538"],"URL":"https:\/\/doi.org\/10.3390\/ijerph21050538","relation":{},"ISSN":["1660-4601"],"issn-type":[{"value":"1660-4601","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,25]]}}}