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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Brain Injuries; Premature Birth
• Intervention / Treatment: Behavioral: Multisensory Stimulation and Family Education Group; Behavioral: Family Education Only Group (FEG)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PI
    • Pisa, PI, Italy, 56125
      • IRCCS Fondazione Stella Maris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multisensory Stimulation and Family Education Group (MSG); 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; 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.
Active Comparator: Family Education Only Group (FEG); 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 family education meetings completed with individual infant parent/s and trained operator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Movements (GM)	The quality of general movements (based on standard observation of infant movements) will be assessed	10-16 weeks corrected age
Electroencephalogram (EEG)	The EEG inter-burst interval, asymmetries and global and local spectral power will be analysed	3 months corrected age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months corrected age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family well-being questionnaires	The Infant Toddler Quality of Life QuestionnaireTM (ITQOL)	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)	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)	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)	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age

Collaborators and Investigators

• Sponsor: University of Pisa
• Collaborators: Azienda Ospedaliero, Universitaria Pisana; Azienda Ospedaliero-Universitaria Careggi; IRCCS Fondazione Stella Maris

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Early Intervention; Family-Centered Care; Neonatology; High-Risk Infant; Sensory Motor Stimulation; Maternal Voice; Tactile stimulation; Kinesthetic stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Brain Injuries; Premature Birth
• Other Study ID Numbers: NelleTueMani

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share the Individual Participant Data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No