NCT05573945

Developmental Care Program in Neonatal Intensive Care Unit

Developmental Family Centred Care Program in Neonatal Intensive Care Unit

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 1 Week – 10 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
BEHAVIORAL	Family Education and Active Listening	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.
BEHAVIORAL	Family Education	Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.

Timeline

• Start date: 2022-05-10
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-10-10
• Last updated: 2025-01-17

Locations

1 site across 1 country: Italy