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Developmental Care Program in Neonatal Intensive Care Unit

NCT05573945 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-01-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • IRCCS Fondazione Stella Maris

    collaborator OTHER

  • University of Pisa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573945 on ClinicalTrials.gov