Developmental Family Centred Care Program in Neonatal Intensive Care Unit
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Birth
- Sponsor
- University of Pisa
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Parent Infant interaction behaviours coding
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.
Detailed Description
Preterm babies, specifically with gestational age \< 33+6 weeks, will be recruited and assigned (randomized) into an a Family Education + Active Listening Group (intervention A) or a Family Education Only Group (intervention B). When the clinical condition of the child is stable the parents are approached for consent and randomised. All families (in intervention A and intervention B) will receive the evidence-based program of Family Education which is based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. It takes its conceptual basis from the Mother Infant Transaction Program (MITP). It is a specific and re-adapted version for the preterm infant hospitalized in NICU The family education sessions involve about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalization in the NICU directly at the child's bed between the operator and one or both parents. Each meeting involves the discussion of one of the following topics. The Families in intervention group A will also receive 4-6 weekly meetings with a psychologist for an active listening counselling session.
Investigators
Andrea Guzzetta
Full Professor
University of Pisa
Eligibility Criteria
Inclusion Criteria
- •Parents of preterm \<34 weeks without brain lesion
Exclusion Criteria
- •Parents of infants with brain Lesions
- •Parents of clinically unstable infants, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)
- •Parents of infants with genetic-malformative conditions
- •Parents with severe psychiatric disorders
Outcomes
Primary Outcomes
Parent Infant interaction behaviours coding
Time Frame: 6 months corrected age
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Developmental outcome assessment
Time Frame: 12 months corrected age
Bayley Scales of Infant Development Third Edition will be conducted including the Cognitive, Language (Receptive \& Expressive), Motor (Gross \& Fine), Social-Emotional and Adaptive sub scales. Each sub scale score will be calculated based on the age (months of age) of the infant at the time assessment. Higher scores mean a better outcome.
Secondary Outcomes
- Family well-being questionnaires(Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age)
- Family well-being questionnaire(Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age)