Premature BirthNTMNCT05542108
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
A study testing Multisensory Stimulation and Family Education Group and Family Education Only Group (FEG) in people with Premature Birth and Brain Injuries, run by University of Pisa at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 week to 10 weeks
- Conditions the study is for
- Premature Birth, Brain Injuries
- What is being tested?
- Multisensory Stimulation and Family Education Group and Family Education Only Group (FEG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 7 Sep 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature infants born <29 weeks of gestation age or premature infants (born < 33+6 weeks gestation age) with a documented brain injury .
Who cannot join
- Clinical instability, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)
- Genetic-malformative conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Multisensory Stimulation and Family Education Group, Family Education Only Group (FEG)
- Keywords
- Early Intervention, Family-Centered Care, Neonatology, High-Risk Infant, Sensory Motor Stimulation, Maternal Voice, Tactile stimulation, Kinesthetic stimulation
- Medical subject headings
- Premature Birth, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory Stimulation and Family Education GroupBehavioural
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)Behavioural
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.
| Study group | Role | What they receive |
|---|---|---|
| Multisensory Stimulation and Family Education Group (MSG) | Experimental | 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. Receives: Behavioral: Multisensory Stimulation and Family Education Group |
| Family Education Only Group (FEG) | Active comparator | 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. Receives: Behavioral: Family Education Only Group (FEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Movements (GM)
The quality of general movements (based on standard observation of infant movements) will be assessed
Measured: 10-16 weeks corrected age
Electroencephalogram (EEG)
The EEG inter-burst interval, asymmetries and global and local spectral power will be analysed
Measured: 3 months corrected age
Secondary outcomes (1)
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.
Measured: 12 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start7 Sep 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two intervention groups, Randomised Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris, Azienda Ospedaliero, Universitaria Pisana, Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Principal investigator, Andrea Guzzetta, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542108
- Sponsor's protocol ID
- NelleTueMani
- Acronym
- NTM
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the Individual Participant Data
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
- ClinicalTrials.gov ID
- NCT05542108
- Acronym / sponsor ID
- NTM / NelleTueMani
- Conditions
- Premature Birth, Brain Injuries
- Keywords
- Early Intervention, Family-Centered Care, Neonatology, High-Risk Infant, Sensory Motor Stimulation, Maternal Voice, Tactile stimulation, Kinesthetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- IRCCS Fondazione Stella Maris, Azienda Ospedaliero, Universitaria Pisana, Azienda Ospedaliero-Universitaria Careggi
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two intervention groups, Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Multisensory Stimulation and Family Education Group (MSG) | Experimental | Behavioral: Multisensory Stimulation and Family Education GroupParents 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. |
| Family Education Only Group (FEG) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 1 week to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- premature infants born <29 weeks of gestation age or premature infants (born < 33+6 weeks gestation age) with a documented brain injury .
Key exclusion criteria (2 listed)
- Clinical instability, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)
- Genetic-malformative conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory Stimulation and Family Education GroupBedside 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. | Behavioural | Multisensory Stimulation and Family Education Group (MSG) |
| 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. | Behavioural | Family Education Only Group (FEG) |
Primary outcome
General Movements (GM)
Time frame: 10-16 weeks corrected age
The quality of general movements (based on standard observation of infant movements) will be assessed
Electroencephalogram (EEG)
Time frame: 3 months corrected age
The EEG inter-burst interval, asymmetries and global and local spectral power will be analysed
1 secondary outcome
Developmental outcome assessment
Time frame: 12 months corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No. There is no plan to share the Individual Participant Data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory Stimulation and Family Education Group and Family Education Only Group (FEG) in people with Premature Birth and Brain Injuries, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Movements (GM) (time frame: 10-16 weeks corrected age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.