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

The Use of an Age-linked Web Application for Parents During and After a NICU Stay in Improving Child Development and Parent Empowerment

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.

Study Overview

• Status: Unknown
• Conditions: Premature Birth
• Intervention / Treatment: Other: Web Application

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Rose Van Hoestenberghe, MD.; Phone Number: +32 89 32 76 33; Email: marie-rose.vanhoestenberghe@zol.be

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg, Schiepse Bos 6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTNIC; NICU Intervention Group Web Application Infants < 32 weeks	Other: Web Application; Parents receive a web application that offers information and support until the age of 2.
No Intervention: CNIC; NICU Control Group No Web Application Infants < 32 weeks
No Intervention: CMAT; Maternity Unit Control Group No Web Application Infants > 37 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PNAR	Parent Newborn Attachment Relationship Questionnaire	2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Collaborators: KU Leuven; TRACE: Centre For Translational Psychological Research
• Investigators: Principal Investigator: Marie-Rose Van Hoestenberghe, MD., Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: prematurity; e-health; parental support; psychomotor development; parent empowerment; post discharge follow-up
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: B331201422729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO