Premature Birth
Conditions
Keywords
Family-Centered Care, Neonatology, Early intervention, Counseling
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.
Interventions
BEHAVIORALFamily Education and Active Listening
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator. In addition, weekly meetings of parent/s with a psychologist in a private location for an active listening counselling session.
BEHAVIORALFamily Education
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.
Sponsors
Azienda Ospedaliero, Universitaria Pisana
IRCCS Fondazione Stella Maris
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Double (Investigator, Outcomes Assessor) Investigator and Outcomes assessors are blind to the group assignment of the infant. Care provider (Parents and Research staff supporting parents in intervention can not be masked to the group assignment).
Intervention model description
Two intervention groups, Randomised Controlled Trial
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 10 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent Infant interaction behaviours coding | 1 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Family well-being questionnaires | Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age | The Infant Toddler Quality of Life QuestionnaireTM (ITQOL) |
| Family well-being questionnaire | Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age | Edinburg Postnatal Depression Scale (EPDS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| General Movements (GM) | 10-16 weeks corrected age | The General Movements Assessment (GMA), an observation of infant spontaneous movements will be completed and scored based on a standard protocol of GMA. The observation allows for the understanding of the neurological risk category for neuromotor difficulties. |
Countries
Italy
Outcome results
None listed