Developmental Outcome of Preterm Infants Enrolled in a Randomized Clinical of a Parent Administered Sensorimotor Intervention in the Neonatal Intensive Care Unit
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Premature Infant
- Sponsor
- Dr. Sandra Fucile
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Attainment of independent oral feeds
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Advances in medical technologies over the last three decades have increased survival rates in infants born preterm . Preterm infants are at high risk of developing developmental delays. Implementation of effective strategies aimed at improving the developmental outcome of preterm born children is critical.
The proposed study is designed to evaluate the addition of a parent administered sensorimotor program on the developmental outcome of infants who are born preterm.
Detailed Description
Children who are born prematurely are at a higher risk of developing developmental delays than children born at term. Early experiences in the neonatal intensive care unit (NICU) can influence developmental outcomes. Sensorimotor interventions as well as parental engagement have been designed with the aim of improving the development of children born preterm. Substantial evidence supports the benefits of each intervention on improving developmental outcomes. However, there remains a significant gap in the literature on the efficacy of a parent administered sensorimotor intervention (PASI) program in the NICU on infant's development. The proposed study is designed to evaluate the potential benefits of such a program on infant's development. A randomized block clinical trial will be performed. A total of 84 preterm infants (\< 34 weeks gestation) will be recruited and randomized. Infants in the experimental group will receive the sensorimotor program,consisting of tactile (whole body) and oral input for 15 minutes, one time per day, for 10 days. Infants in the control group will receive standard care. The following outcomes will be monitored time to attainment of complete oral feeds (primary outcome), rate of weight gain, length of hospitalization, and developmental outcomes at 36 weeks corrected gestational age and at 4, 8, 12, 18 and 24 months corrected age. Results from this study will provide us with further knowledge on the impact of sensorimotor intervention on infants' developmental outcome as well as the effect of active parental involvement on infants' development. Provision of a PASI program is a safe and low cost effective intervention that may increase the development and quality of life of preterm born children and their family.
Investigators
Dr. Sandra Fucile
PI
Queen's University
Eligibility Criteria
Inclusion Criteria
- •Infants born \< 34 weeks gestation
- •Infants whose parent (s) intend on visiting regularly (\> 5 days)
Exclusion Criteria
- •Infants born with a metabolic disorder or congenital abnormality
- •Infants whose parents are unable to participate due to cognitive, physical or social issues.
Outcomes
Primary Outcomes
Attainment of independent oral feeds
Time Frame: 3 years
Number of days to transition from complete tube to complete oral feeds.
Secondary Outcomes
- Length of hospital stay(3 years)
- Test of infant motor performance(3 years)
- Weight gain(3 years)
- Acute stress of parents(3 years)