Abstract
Abstract Introduction: A daycare center is a long-term place for infants, which means that early intervention programs should be thought of in this environment. There are still many gaps regarding the best way of stimulation/intervention, duration and description of effects and controlled outcomes. Aim: The objective of this clinical trial is to propose an early physical activity intervention program performed in infants of 4-18 months with risk/delay and with typical development at infant’s daycare. Method: The protocol of this study is indicated for a controlled trial, in a crossover format, to be applied in 4 groups composed by in 4-18 month-old infants who attend daycare: Intervention group 1 Typical, Intervention group 1 Risk/delay, group Intervention 2 Typical, group Intervention 2 Risk/delay, in 4-18 month old infants who attend daycare. The ICF criteria about functions and structure (through evaluation questionnaire) are considered, as well as activities and participation (AIMS, Denver II, and PedsQl™ evaluation), personal characteristics (questionnaire, ABEP and AHEMD-IS) and environmental factors (AHEMD-IS). Conclusion: This original proposal can highlight a low-cost intervention program performed in a daycare environment verifying the infant's NMD in a systematized way using theoretical basis.
Highlights
The study on child development is not recent, the focus on neuromotor early intervention performed in a systematized using the theoretical basis is still scarce mainly in Brazil, and there are different gaps according to the type of intervention, duration, and description of controlled effects and outcomes
All items from the World Health Organization (WHO) Trial Registration Data Set were registered at the Brazilian Registry of Clinical Trials (RBR 2hd6sm)[1]
Considering the value of children 0-4 years as approximately 107,000 children[17] in Curitiba (Parana-Brazil), with an estimated total of 50,000 infants in daycare centers/schools (Curitiba Department of Education) and considering an estimation of delay in the neuromotor development (NMD) of 30%, we considered the sample calculation formula assuming a sampling error of 10% and taking 4 measurements repeated for the main outcome, we obtained n=52 of the sample size calculation, allocated in Intervention group 1 Typical (n=20), group Intervention 2 Typical (n=20), group Intervention 1 Typical (n=6), group Intervention 2 Typical 2 (n=6), with study performed in a cross-over design, assuming effect size 0.2518, type I error 0.05, analysis power of 0.95
Summary
The study on child development is not recent, the focus on neuromotor early intervention performed in a systematized using the theoretical basis is still scarce mainly in Brazil, and there are different gaps according to the type of intervention, duration, and description of controlled effects and outcomes. These aspects need to be investigated, considering that approximately 200 million children under 5 years old in developing countries, such as Brazil, are predisposed to neuromotor development (NMD) delay due to various factors such as poverty, lack of proper care and early stimulation[1]. These evaluations are relevant in a country like Brazil that still has high rates of school failure[8,9] with repercussions on children’s future development
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