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

NCT03232190 | Unknown DMC

• 1 other identifier: B331201422729
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

prematurity; psychomotor development; parent empowerment; e-health; parental support; post discharge follow-up

Outcome Measures

Primary Outcomes (4)

• Change in Bayley-III-NL

  Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child

  5 months, 1 year, 2 year

• Change in DT-P

  Distress Thermometer for Parents

  2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year

• Change in EMPO

  Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)

  2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year

• WPPSI-III-NL

  Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child

  5 year

Secondary Outcomes (1)

• Change in PNAR

  2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year

Study Arms (3)

INTNIC

EXPERIMENTAL

NICU Intervention Group Web Application Infants \< 32 weeks

Other: Web Application

CNIC

NO INTERVENTION

NICU Control Group No Web Application Infants \< 32 weeks

CMAT

NO INTERVENTION

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

Interventions

Web Application OTHER

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

INTNIC

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature birth (\< 32 weeks)

You may not qualify if:

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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• KU Leuven: collaborator
• TRACE: Centre For Translational Psychological Research: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg, Schiepse Bos 6

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie-Rose Van Hoestenberghe, MD.

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Rose Van Hoestenberghe, MD.

CONTACT

+32 89 32 76 33; marie-rose.vanhoestenberghe@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: July 27, 2017
• Study Start: January 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)