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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05573945
Study type Interventional
Source University of Pisa
Contact
Status Enrolling by invitation
Phase N/A
Start date May 10, 2022
Completion date December 31, 2024

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