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

Premature Birth Clinical Trial

— NTM  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05542108
• Other study ID #: NelleTueMani
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: September 2022
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: January 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week to 10 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Stella Maris	Pisa	PI

Sponsors (4)

Lead Sponsor	Collaborator
University of Pisa	Azienda Ospedaliero, Universitaria Pisana, Azienda Ospedaliero-Universitaria Careggi, IRCCS Fondazione Stella Maris

Country where clinical trial is conducted

Italy, 

Outcome

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