Developmental Care Program in Neonatal Intensive Care Unit

NCT ID: NCT05573945

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2025-12-31

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.

Conditions

Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Family Education Only

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.

Group Type: EXPERIMENTAL

Family Education and Active Listening

Intervention Type: BEHAVIORAL

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 Education and Active Listening

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.

Group Type: ACTIVE_COMPARATOR

Family Education

Intervention Type: BEHAVIORAL

Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Intervention A; Intervention B

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: collaborator

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: collaborator

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Andrea Guzzetta

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Fondazione Stella Maris

Pisa, PI, Italy

Countries

Italy

Other Identifiers

CIN

Identifier Type: -

Identifier Source: org_study_id