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NOT YET RECRUITING
NCT06495762

Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research

Sponsor: University of Milano Bicocca

View on ClinicalTrials.gov

Summary

The consequences of preterm birth extend beyond the clinical conditions of the newborn, profoundly impacting the functioning and well-being of families. Although various research examines changes in parents' well-being and perception of self-efficacy during the stay in NICU, there is a lack of research analyzing what happens in the delicate transition phase at home after the baby's discharge. Recently, scholars have advocated for the use of web-based and app-based support programs both to monitor and prevent preterm family maladjustment and to assist parents struggling with the transition home. The main aim of this interdisciplinary research project is to develop a socio-psychological model focused on assessing the well-being of parents of premature infants during and after their stay in a NICU. Specifically, the study aims to (1) monitor the mental health of parents of premature infants, both at the time of the child's discharge from the NICU and in the first six months after discharge to prevent family maladjustment, (2) deepen our understanding of the role of digital tools in monitoring and supporting the well-being of parents of premature infants, and (3) study the potential impact of the relationship with healthcare professionals on the overall well-being of parents. The project combines mixed methods of social research and psychological support with an e-health approach. The well-being of parents of premature infants will be assessed using validated scales administered through a questionnaire to parents of preterm infants within six NICUs at the time of the child's discharge. Subsequently, a follow-up assessment of parental well-being will be implemented through the administration of the validated scales in a web app. Additionally, an ethnographic phase will be conducted in the NICUs, involving observation of the interaction between healthcare professionals and parents, as well as narrative interviews with healthcare staff. It is expected to shed light on the determinants of well-being among parents of premature infants, in relation to varying levels of prematurity severity, socio-demographic characteristics such as gender, age, and socioeconomic status, and parental involvement in NICU care practices. With the follow-up phase via web app, the project also aims to prevent family maladjustment by providing psychological support and utilizing an e-health tool.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2024-09-02

Completion Date

2025-10-01

Last Updated

2024-07-11

Healthy Volunteers

Yes

Interventions

OTHER

e-health assesment

This study is purely observational and does not forsee any intervention but only observational assesment of parents' wellbeing

Locations (6)

Dipartimento Materno infantile, Terapia Intensiva Neonatale, Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, CA, Italy

S.C. Neonatologia e Terapia Intensiva Neonatale, I.R.C.C.S. Ospedale San Gerardo Monza

Monza, MB, Italy

U.O Neonatologia e Patologia Neonatale, I.R.C.C.S. Ospedale San Raffaele

Milan, MI, Italy

S.C. Neonatologia e Terapia Intensiva Neonatale, Fondazione IRCCS Policlinico San Matteo di Pavia.

Pavia, PV, Italy

U.O.C. di Terapia Intensiva Neonatale, patologia neonatale ed assistenza al neonato sano presso il Presidio Ospedaliero di Treviso

Treviso, TV, Italy

UOSD di Terapia Intensiva e Patologia Neonatale presso l'ospedale di Vicenza (ULSS 8 Berica).

Vicenza, VI, Italy