Developmental Care Program in Neonatal Intensive Care Unit

NCT05573945 | Unknown

• 1 other identifier: CIN
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Family-Centered Care; Neonatology; Early intervention; Counseling

Outcome Measures

Primary Outcomes (4)

• Parent Infant interaction behaviours coding

  Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.

  1 months corrected age

• Parent Infant interaction behaviours coding

  Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.

  3 months corrected age

• Parent Infant interaction behaviours coding

  Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.

  6 months corrected age

• Developmental outcome assessment

  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.

  12 months corrected age

Secondary Outcomes (4)

• Family well-being questionnaires

  Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age

• Family well-being questionnaire

  Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age

• Family well-being questionnaire

  Frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age

• Family well-being questionnaire

  Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age

Other Outcomes (1)

• General Movements (GM)

  10-16 weeks corrected age

Study Arms (2)

Family Education Only

EXPERIMENTAL

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.

Behavioral: Family Education and Active Listening

Family Education and Active Listening

ACTIVE COMPARATOR

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.

Behavioral: Family Education

Interventions

Family Education and Active Listening 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.

Also known as: Intervention A

Family Education Only

Family Education 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.

Also known as: Intervention B

Family Education and Active Listening

Eligibility Criteria

• Age: 1 Week - 10 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents of preterm \<34 weeks without brain lesion

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• IRCCS Fondazione Stella Maris: collaborator

Study Sites (1)

IRCCS Fondazione Stella Maris

Pisa, PI, 56125, Italy

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Sex Education

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sexology; Behavioral Sciences; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double (Investigator, Outcomes Assessor) Investigator and Outcomes assessors are blind to the group assignment of the infant. Care provider (Parents and Research staff supporting parents in intervention can not be masked to the group assignment).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Two intervention groups, Randomised Controlled Trial

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 10, 2022
• Study Start: May 10, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)