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Early intervention program for very low birth weight preterm infants and their parents: a study protocol
Rita C Silveira1,2, Eliane Wagner Mendes3, Rubia Nascimento Fuentefria4
1Universidade Federal do Rio Grande do Sul, Rua Silva Jardim 1155 # 701, Porto Alegre, RS, 90450071, Brazil. drarita.c.s@gmail.com.
Insights
Early parental stimulation through a home-based intervention program can improve neurodevelopment in very preterm infants. This intervention, involving kangaroo care and tactile-kinesthetic stimulation, aims to enhance cognitive and motor skills for better long-term outcomes.
Area of Science:
- Neonatal care and developmental pediatrics.
- Neuroscience and developmental psychology.
- Public health initiatives in early childhood development.
Background:
- Very preterm infants face significant risks for delayed neurodevelopment.
- Early intervention programs are crucial for mitigating these risks.
- Parental involvement in early stimulation is key to improving infant outcomes.
Purpose of the Study:
- To develop and evaluate a home-based early intervention program for very preterm infants.
- To quantify the effects of early parental stimulation on cognitive and motor skill development.
- To assess the feasibility of continuous, family-applied interventions for improving neurodevelopmental outcomes.
Main Methods:
- A randomized clinical trial involving preterm infants (gestational age < 32 weeks or birth weight < 1500g).
- Intervention group received kangaroo care, tactile-kinesthetic stimulation, and a structured home-based program.
- Outcomes assessed using Bayley Scales of Infant and Toddler Development and Alberta Motor Infant Scale at 12-18 months.
Main Results:
- The study aims to demonstrate the efficacy of a continuous, global early intervention program.
- Positive results could support the widespread application of this program for low-income families.
- The intervention is designed to anticipate developmental milestones for improved motor and cognitive acquisition.
Conclusions:
- A home-based early intervention program shows promise for enhancing neurodevelopment in very preterm infants.
- Continuous parental stimulation can lead to significant improvements in cognitive and motor skills.
- This approach offers a scalable model for global implementation in neonatal care.
Background:
Preterm 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.
Methods:
Randomized 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.
Discussion:
If 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 Registration:
The study was restrospectively registered in ClinicalTrials.gov . in July 15 2016 ( NCT02835612 ).
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