The Use of an Age-linked App for Parents During and After a NICU Stay

NCT ID: NCT03232190

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2022-12-31

Brief Summary

The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of the newborn. Preterm children are at greater risk for developmental disorders. On the one hand, this is due to cerebral complications inherent to the prematurity, on the other hand it is related to the very early and therefore vulnerable stage of brain development at the time of the premature birth. The development of the child is also the result of a constant interaction between the infant and its environment, primarily the primary caregiver (i.e. the parents). A premature birth can cause great stress to parents, and there are several obstacles that can make it difficult to handle their child. Therefore, we have developed a web application that supports parents until their child reaches the age of two. By keeping them informed, we hope to make them more confident in their role as parents, and thus facilitate the parent-child interaction. In order to determine whether this form of support has an additional effect on the development of the premature child, we compare two groups of premature infants and a group of non-premature infants.

Conditions

Premature Birth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

INTNIC

NICU Intervention Group Web Application Infants \< 32 weeks

Group Type: EXPERIMENTAL

Web Application

Intervention Type: OTHER

Parents receive a web application that offers information and support until the age of 2.

CNIC

NICU Control Group No Web Application Infants \< 32 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

CMAT

Maternity Unit Control Group No Web Application Infants \> 37 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web Application

Parents receive a web application that offers information and support until the age of 2.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Premature birth (< 32 weeks)

Exclusion Criteria

• The lack of internet access or a personal email account
• Little or no knowledge of Dutch in both parents
• Children with a congenital disease

• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

TRACE: Centre For Translational Psychological Research

UNKNOWN

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Marie-Rose Van Hoestenberghe, MD

Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie-Rose Van Hoestenberghe, MD.

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg, Schiepse Bos 6

Genk, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Marie-Rose Van Hoestenberghe, MD.

Role: CONTACT

marie-rose.vanhoestenberghe@zol.be

+32 89 32 76 33

Other Identifiers

B331201422729

Identifier Type: -

Identifier Source: org_study_id