Effects of home guidance provided by parents on the functionality of infants at biological risk
- Conditions
- Infants with conditions originating in the perinatal period:- Other preterm infants - Extremely low birth weight - Birth asphyxia, unspecifiedP00-P96
- Registration Number
- RBR-8xrzjs
- Lead Sponsor
- niversidade Federal de São Carlos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Infants aged 3 to 12 months of corrected age will be included; of both sexes; with moderate to high risk for developmental delay. Moderate to high risk infants will be considered to be those who meet at least one of the following criteria, being they born before 33 weeks of gestational age; weight below the 10th percentile according to gestational age and sex; Apgar score from 0 to 3 for more than 5 minutes; neurological manifestations in the neonate such as seizures, coma or hypotonia; need for cardiorespiratory resuscitation or use of oxygen therapy; prolonged hospital stay in the Intensive Care Unit; presence of abnormal General movements.
Infants over 12 months of age will not be included in the study; no risk of developmental delay; who have diagnosed primary diseases and congenital diseases; autism; Down's syndrome; muscular dystrophies; heart diseases; renal changes; bone deformities; confirmed blindness or deafness; infants with severe respiratory diseases; epilepsy or frequent seizures.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected primary outcome 1: improvement in motor skills, assessed by the Infant Motor Profile scale (total score), through an increase of at least 15% of the total value of the scale score. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.;Expected primary outcome 2: improvement in motor skills, assessed by the Alberta Infant Motor Scale, through the addition of the infant's percentile. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.
- Secondary Outcome Measures
Name Time Method Expected secondary outcome 2: improvement in participation, assessed by the Young Children’s Participation and Environment Measure scale, by increasing the scale's total participation score by 15%. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.;Expected secondary outcome 1: improvement in mother-child interaction, assessed using the Parent-Child Early Relational Assessment scale, by increasing the scale's total score by 10%. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.;Expected secondary outcome 3: increase in opportunities available in the home environment, assessed by the Affordances in the Home Environment for Motor Development scale, by increasing the scale's total score by 10%. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.