Developmental Care Program in Neonatal Intensive Care Unit

Not Applicable

• Conditions: Premature Birth
• Interventions: Behavioral: Family Education; Behavioral: Family Education and Active Listening

• Registration Number: NCT05573945
• Lead Sponsor: University of Pisa

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.

Study Timeline

• Study Start: 2022-05-10
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Status Verified: 2024-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Education and Active Listening	Family Education	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.
Family Education Only	Family Education and Active Listening	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.

Primary Outcome Measures

Name	Time	Method
Parent Infant interaction behaviours coding	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	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.

Secondary Outcome Measures

Name	Time	Method
Family well-being questionnaires	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age	The Infant Toddler Quality of Life QuestionnaireTM (ITQOL)
Family well-being questionnaire	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age	Coping Orientation to Problems Experienced (COPE - NVI)

Trial Locations

Locations (1)

IRCCS Fondazione Stella Maris; 🇮🇹 Pisa, PI, Italy