Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Cognitive abilities
Study Overview
Brief Summary
When becoming a parent of a preterm infant there is an increased risk of stress. There are a number of studies showing that parental stress has a negative impact on their engagement with their child. Other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. Structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions.
The investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. The observational program is called LiMoNid. Our hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. They will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. Parental stress may also be reduced by increased understanding and control. Regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. The emotional regulation should be strengthened by such an intervention.
The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child interaction.
Detailed Description
The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 96 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infants born 30-36 weeks gestational age without known major malformations or complications
- •Families living in the county of Ostergotland, Sweden
- •Swedish speaking parents
- •Single or duplex birth
Exclusion Criteria
- •Complications encountered during hospital stay that are known to affect cognition
Outcomes
Primary Outcomes
Cognitive abilities
Time Frame: 11 months
Bayley Scales of Infant Development
Secondary Outcomes
- Stress reactivity(1 month)
Investigators
Evalotte Morelius
Professor
Linkoeping University