Developmental Care Program in Neonatal Intensive Care Unit (CIN)

Developmental Family Centred Care Program in Neonatal Intensive Care Unit

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Family Education and Active Listening; Behavioral: Family Education

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PI
    • Pisa, PI, Italy, 56125
      • IRCCS Fondazione Stella Maris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 months (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Intervention A
Active Comparator: 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.	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.; Other Names: Intervention B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family well-being questionnaires	The Infant Toddler Quality of Life QuestionnaireTM (ITQOL)	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire	Edinburg Postnatal Depression Scale (EPDS)	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire	Coping Orientation to Problems Experienced (COPE - NVI)	Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire	Depression Anxiety Stress Scale (DASS-21)	Frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Movements (GM)	The General Movements Assessment (GMA), an observation of infant spontaneous movements will be completed and scored based on a standard protocol of GMA. The observation allows for the understanding of the neurological risk category for neuromotor difficulties.	10-16 weeks corrected age

Collaborators and Investigators

• Sponsor: University of Pisa
• Collaborators: Azienda Ospedaliero, Universitaria Pisana; IRCCS Fondazione Stella Maris

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Counseling; Early intervention; Family-Centered Care; Neonatology
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: CIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share the Individual Participant Data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No