An interventional study of Multisensory Stimulation and Family Education Group and Family Education Only Group (FEG) in Premature Birth and Brain Injuries, sponsored by University of Pisa. Status unknown at 1 site in Italy. Open to participants aged 1 Week to 10 Weeks. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by University of Pisa · Not applicable, Interventional, and Treatment
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 24 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Pisa is the lead sponsor of 111 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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. 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. 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.
Behavioral: Multisensory Stimulation and Family Education Group
Parents of the FEG group infants will be asked to participate in an evidence based program for parents of NICU infants that includes 6-8 visits with a a trained healthcare provider operator. This evidence-based program of early intervention based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. The program takes its conceptual basis from the Mother Infant Transaction Program (MITP). It involves 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.
Behavioral: Family Education Only Group (FEG)
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.
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.
General Movements (GM)
The quality of general movements (based on standard observation of infant movements) will be assessed
Time frame: 10-16 weeks corrected age
Electroencephalogram (EEG)
The EEG inter-burst interval, asymmetries and global and local spectral power will be analysed
Time frame: 3 months corrected age
Developmental outcome assessment
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.
Time frame: 12 months corrected age
Family well-being questionnaires
The Infant Toddler Quality of Life QuestionnaireTM (ITQOL)
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Edinburg Postnatal Depression Scale (EPDS)
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Depression Anxiety Stress Scale (DASS-21)
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Coping Orientation to Problems Experienced (COPE - NVI)
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Plan to share: No — There is no plan to share the Individual Participant Data
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of Pisa