NCT05542108

Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 1 Week – 10 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth
• Brain Injuries

Interventions

Type	Name	Description
BEHAVIORAL	Multisensory 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.
BEHAVIORAL	Family 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.

Timeline

• Start date: 2021-09-07
• Primary completion: 2023-09-30
• Completion: 2024-01-30
• First posted: 2022-09-15
• Last updated: 2022-09-15

Locations

1 site across 1 country: Italy