Evaluation of a Parent-Infant Interaction Model

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Parent-Infant Interaction Model in the Neonatal Intensive Care

Conditions
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Premature Birth

Intervention / Treatment
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* Behavioral: LiMoNid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 96 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>The family receive standard care when enrolled in the Neonatal intensive care unit | |
| Experimental: Observation<br>The family receive standard care when enrolled in the Neonatal intensive care unit and are also included in an observational program called LiMoNid. | Behavioral: LiMoNid<br>* One LiMoNid observation will be performed on day 1-3 post birth, one in time of discharge, and one in the home when the infant has reached 40 weeks (+/- 2 week). All observations are performed in presence of and in collaboration with the parents with the outspoken aim to guide the parents to learn how to read and respond to their infant' signals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive abilities | Bayley Scales of Infant Development | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress reactivity | Salivary cortisol reactivity in relation to bath | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Family nursing, Infant, premature, Object attachment, Stress, physiological, Stress, psychological