Premature BirthCINNCT05573945
Developmental Care Program in Neonatal Intensive Care Unit
A study testing Family Education and Active Listening and Family Education in people with Premature Birth, run by University of Pisa at 1 site in Italy.
Trial summary
This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling 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
- What is being tested?
- Family Education and Active Listening and Family Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2022to 31 Dec 2025
- 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
- Parents of preterm <34 weeks without brain lesion
Who cannot join
- Parents of infants with brain Lesions
- Parents of clinically unstable infants, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)
- Parents of infants with genetic-malformative conditions
- Parents with severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developmental Family Centred Care Program in Neonatal Intensive Care Unit
This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.
Read the detailed description
Preterm babies, specifically with gestational age < 33+6 weeks, will be recruited and assigned (randomized) into an a Family Education + Active Listening Group (intervention A) or a Family Education Only Group (intervention B).
When the clinical condition of the child is stable the parents are approached for consent and randomised.
All families (in intervention A and intervention B) 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 sessions involve 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. Each meeting involves the discussion of one of the following topics.
The Families in intervention group A will also receive 4-6 weekly meetings with a psychologist for an active listening counselling session.
- Conditions
- Premature Birth
- Being tested
- Family Education and Active Listening, Family Education
- Keywords
- Family-Centered Care, Neonatology, Early intervention, Counseling
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Education and Active ListeningBehavioural
Also called Intervention A
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator. In addition, weekly meetings of parent/s with a psychologist in a private location for an active listening counselling session.
Family EducationBehavioural
Also called Intervention B
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 |
|---|---|---|
| Family Education Only | Experimental | Family Education Only. Parents will be asked to participate in an evidence based program s that includes 6-8 visits with a a trained healthcare provider.
This 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.
Active listening Visits includes a cycle of 5-6 consecutive meetings lasting about an hour. The meetings will take place in a defined and dedicated space (private room) or if possible (if no other parents are present) at the baby's cradle. The meeting will take place between a single parent and a trained direct operator. This is not a psychotherapeutic intervention but a support that is provided to the parent. The support is mainly based on active listening, on the problems posed by the parent and on the subject's empowerment. Receives: Behavioral: Family Education and Active Listening |
| Family Education and Active Listening | Active comparator | Family Education and Active Listening. Parents of 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 hospitalisation in the NICU directly at the child's bed between the operator and one or both parents. Receives: Behavioral: Family Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Infant interaction behaviours coding
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Measured: 1 months corrected age
Parent Infant interaction behaviours coding
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Measured: 3 months corrected age
Parent Infant interaction behaviours coding
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Measured: 6 months corrected age
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
Secondary outcomes (4)
Family well-being questionnaires
The Infant Toddler Quality of Life QuestionnaireTM (ITQOL)
Measured: 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)
Measured: 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)
Measured: Frame: 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)
Measured: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 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 posted10 Oct 2022
- Study start10 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two intervention groups, Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana, IRCCS Fondazione Stella Maris
- Responsible party
- Principal investigator, Andrea Guzzetta, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573945
- Sponsor's protocol ID
- CIN
- Acronym
- CIN
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2022
- Last updated
- 17 Jan 2025
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Family Centred Care Program in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05573945
- Acronym / sponsor ID
- CIN / CIN
- Conditions
- Premature Birth
- Keywords
- Family-Centered Care, Neonatology, Early intervention, Counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana, IRCCS Fondazione Stella Maris
- Study start
- 10 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Oct 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 family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.
Detailed description
Preterm babies, specifically with gestational age < 33+6 weeks, will be recruited and assigned (randomized) into an a Family Education + Active Listening Group (intervention A) or a Family Education Only Group (intervention B).
When the clinical condition of the child is stable the parents are approached for consent and randomised.
All families (in intervention A and intervention B) 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 sessions involve 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. Each meeting involves the discussion of one of the following topics.
The Families in intervention group A will also receive 4-6 weekly meetings with a psychologist for an active listening counselling session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two intervention groups, Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Family Education Only | Experimental | Behavioral: Family Education and Active ListeningFamily Education Only. Parents will be asked to participate in an evidence based program s that includes 6-8 visits with a a trained healthcare provider. This 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. Active listening Visits includes a cycle of 5-6 consecutive meetings lasting about an hour. The meetings will take place in a defined and dedicated space (private room) or if possible (if no other parents are present) at the baby's cradle. The meeting will take place between a single parent and a trained direct operator. This is not a psychotherapeutic intervention but a support that is provided to the parent. The support is mainly based on active listening, on the problems posed by the parent and on the subject's empowerment. |
| Family Education and Active Listening | Active comparator | Behavioral: Family EducationFamily Education and Active Listening. Parents of 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 hospitalisation 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)
- Parents of preterm <34 weeks without brain lesion
Key exclusion criteria (4 listed)
- Parents of infants with brain Lesions
- Parents of clinically unstable infants, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation)
- Parents of infants with genetic-malformative conditions
- Parents with severe psychiatric disorders
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 |
|---|---|---|
| Family Education and Active ListeningAlso: Intervention ABedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator. In addition, weekly meetings of parent/s with a psychologist in a private location for an active listening counselling session. | Behavioural | Family Education Only |
| Family EducationAlso: Intervention BBedside 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 and Active Listening |
Primary outcome
Parent Infant interaction behaviours coding
Time frame: 1 months corrected age
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Parent Infant interaction behaviours coding
Time frame: 3 months corrected age
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Parent Infant interaction behaviours coding
Time frame: 6 months corrected age
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Developmental outcome assessment
Time frame: 12 months corrected age
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.
4 secondary outcomes
Family well-being questionnaires
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Time frame: Frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 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 17 Jan 2025.
- Individual participant dataSharing planned: No. There is no plan to share the Individual Participant Data
Related trials for Premature Birth
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
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 Family Education and Active Listening and Family Education in people with Premature Birth, 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 4 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 17 Jan 2025. 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?
Parent Infant interaction behaviours coding (time frame: 1 months corrected age). The study lists 4 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 17 Jan 2025.