Early intervention program for very low birth weight preterm infants and their parents: a study protocol

Abstract

BackgroundPreterm infants are high risk for delayed neurodevelopment. The main goal is to develop a program of early intervention for very preterm infants that allows families to apply it continuously at home, and quantify the results of early parental stimulation on improvement of cognition and motor skills.MethodsRandomized clinical Trial including inborn preterm infants with gestational age less than 32 weeks or birth weight less than 1500 g at 48 h after birth. Eligible for begin the intervention up to 7 days after birth. Study Protocol approved by the Brazilian national Committee of ethics in Research and by the institutional ethics committee.Intervention group (IG): skin-to skin care by mother (kangaroo care) plus tactile-kinesthetic stimulation by mothers from randomization until hospital discharge when they receive a program of early intervention with 10 parents’ orientation and a total of 10 home visits independently of the standard evaluation and care that will be performed. Systematic early intervention program will be according to developmental milestones, anticipating in a month evolutionary step acquisition of motor and / or cognitive expected for corrected age. Active comparator with a Conventional Group (CG): standard care according to the routine care of the NICU and their needs in the follow up program. Neurodevelopment outcome with blinded evaluations in both groups between 12 and 18 months by Bayley Scales of Infant and Toddler Development third edition and Alberta Motor Infant scale will be performed. All evaluations will be conducted in the presence of parents or caregivers in a safe room for the child move around during the evaluation.DiscussionIf we can show that a continuous and global early intervention at home performed by low income families is better than the standard care for very preterm infants, this kind of program may be applied elsewhere in the world. We received grants by Bill and Melinda Gates Foundation, DECIT, Cnpq and Health Ministry. Grand Challenges Brazil: All Children Thriving.Trial registrationThe study was restrospectively registered in ClinicalTrials.gov. in July 15 2016 (NCT02835612).

Very Low Birth Weight Preterm Children Motor Performance in the First Year of Life

“…In view of the above, it is important to emphasize the importance of intervention measures to minimize future sequels and to promote a better quality of life for children, thus avoiding that alterations remain at an older age 7,11 . Within this context, it is also noteworthy how significant the intervention and guidance performed with parents is, since adequate maternal practices proved effective in improving the child's motor repertoire [21][22][23] .…”

“…Therefore, although the development of very low birth weight premature babies may present problems in several domains, extending throughout childhood, intervention programs focused on development may favor the children's motor performance and long-term cognitive abilities 7 . Early intervention and multidisciplinary follow-up favor the motor development and attenuation of morbid aspects associated with prematurity and very low, especially in children from low-income families, whose environmental risk factors may be an aggravating factor to the already existing biological ones 7 .…”

Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial

“…Another limitation of this report not related to the findings per se is our understanding of how FNI can bring about such long-term changes in autonomic regulation. As noted above there are many NICU interventions tested and other new ones have been designed [59]. For all of these approaches we believe there is need to propose and test theories of change and mechanisms that would account for their effectiveness.…”

Movement Imitation Therapy for Preterm Babies (MIT-PB): a Novel Approach to Improve the Neurodevelopmental Outcome of Infants at High-Risk for Cerebral Palsy

“…CS GMs over a period of at least 3 consecutive weeks). Such early identification cries out for early intervention, but we only know little about the effect of intervention that already starts preterm (Hadders-Algra 2014 ; Silveira et al 2018 ; Hutchon et al 2019 ).…”