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

Not Applicable

• Conditions: Premature Birth
• Interventions: Other: Web Application

• Registration Number: NCT03232190
• Lead Sponsor: Ziekenhuis Oost-Limburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTNIC	Web Application	NICU Intervention Group Web Application Infants \< 32 weeks

Primary Outcome Measures

Name	Time	Method
Change in EMPO	2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year	Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)
WPPSI-III-NL	5 year	Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child
Change in Bayley-III-NL	5 months, 1 year, 2 year	Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child
Change in DT-P	2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year	Distress Thermometer for Parents

Secondary Outcome Measures

Name	Time	Method
Change in PNAR	2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year	Parent Newborn Attachment Relationship Questionnaire

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg, Schiepse Bos 6; 🇧🇪 Genk, Limburg, Belgium