Clinical trial NCT05573945: Developmental Care Program in Neonatal Intensive Care Unit
Official title: Developmental Family Centred Care Program in Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Premature Birth
Keywords: Family-Centered Care
Neonatology
Early intervention
Counseling
Lead sponsor: University of Pisa
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Pisana
name: IRCCS Fondazione Stella Maris
First posted: 2022-10-10
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two intervention groups, Randomised Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Parents of preterm \<34 weeks without brain lesion

Exclusion Criteria:

* 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

Primary outcomes:
measure: Parent Infant interaction behaviours coding
timeFrame: 1 months corrected age
measure: Parent Infant interaction behaviours coding
timeFrame: 3 months corrected age
measure: Parent Infant interaction behaviours coding
timeFrame: 6 months corrected age
measure: Developmental outcome assessment
timeFrame: 12 months corrected age
Secondary outcomes:
measure: Family well-being questionnaires
timeFrame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
measure: Family well-being questionnaire
timeFrame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
measure: Family well-being questionnaire
timeFrame: Frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
measure: Family well-being questionnaire
timeFrame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Other outcomes:
measure: General Movements (GM)
timeFrame: 10-16 weeks corrected age
Locations:
city: Pisa
country: Italy
facility: IRCCS Fondazione Stella Maris
state: PI
Study officials:
References: