Clinical trial NCT05542108: Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
Official title: Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Birth
Brain Injuries
Keywords: Early Intervention
Family-Centered Care
Neonatology
High-Risk Infant
Sensory Motor Stimulation
Maternal Voice
Tactile stimulation
Kinesthetic stimulation
Lead sponsor: University of Pisa
Sponsor class: OTHER
Collaborators: name: IRCCS Fondazione Stella Maris
name: Azienda Ospedaliero, Universitaria Pisana
name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2022-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two intervention groups, Randomised Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: General Movements (GM)
timeFrame: 10-16 weeks corrected age
measure: Electroencephalogram (EEG)
timeFrame: 3 months corrected age
Secondary outcomes:
measure: Developmental outcome assessment
timeFrame: 12 months corrected age
Other outcomes:
measure: Family well-being questionnaires
timeFrame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
measure: Family well-being questionnaire
timeFrame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
measure: Family well-being questionnaire
timeFrame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
measure: Family well-being questionnaire
timeFrame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Locations:
city: Pisa
country: Italy
facility: IRCCS Fondazione Stella Maris
state: PI
Study officials:
References: