Brain Injuries, Premature Birth
Conditions
Keywords
Early Intervention, Family-Centered Care, Neonatology, High-Risk Infant, Sensory Motor Stimulation, Maternal Voice, Tactile stimulation, Kinesthetic stimulation
Brief summary
This project is a Randomised Clinical Trial that includes a tactile-kinesthetic somatosensory stimulation or family centred education intervention with families of preterm infants at risk for sensori-motor disorders. This is a study will be based on the adaptation of the intervention previously described and published by Guzzetta and colleagues (2009), and will include an improved and increased kinesthetic component, to be performed in infants born very prematurely and preterm infants with a documented brain injury. The intervention will start in neonatology during the infant hospitalization and continue at the child's home until two months of correct age.
Detailed description
Preterm babies, specifically with gestational age \< 33+6 weeks, will be recruited and assigned (randomized) into an a Multisensory stimulation + Family Education Group (MSG) or a Family Education Only Group (FEG). When the clinical condition of the child is stable and after a short training, parents of the MSG will be asked to carry out up to two treatment sessions per day with their child, until they reach the 8th post-term week. Sessions will initially be carried out together with a therapist who will have the task of transmitting the necessary skills to parents/caregivers. The therapist will assist parents through practical demonstrations, theoretical explanations and by answering the parents' questions. The treatment will consist of sessions of approximately 25-30 minutes. The main purposes of the intervention will be clearly explained to the parents, and in particular the goal of maintaining a calm and natural interaction during the session. In addition, all families 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 group sessions involve about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalization in the NIC 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.
Interventions
BEHAVIORALMultisensory Stimulation and Family Education Group
Bedside intervention directly with infant with trained healthcare providers and parents. Includes two parts: twice daily multisensory stimulation sessions and separate family education meetings completed with individual infant parent/s and trained operator.
BEHAVIORALFamily Education Only Group (FEG)
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
IRCCS Fondazione Stella Maris
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliero-Universitaria Careggi
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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
* premature infants born \<29 weeks of gestation age or premature infants (born \< 33+6 weeks gestation age) with a documented brain injury .
Exclusion criteria
* Clinical instability, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation) * Genetic-malformative conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Movements (GM) | 10-16 weeks corrected age | The quality of general movements (based on standard observation of infant movements) will be assessed |
| Electroencephalogram (EEG) | 3 months corrected age | The EEG inter-burst interval, asymmetries and global and local spectral power will be analysed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| 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) |
Countries
Italy
Outcome results
None listed