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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03232190
• Other study ID #: B331201422729
• Status: Recruiting
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: July 2019
• Source: Ziekenhuis Oost-Limburg
• Contact: Marie-Rose Van Hoestenberghe, MD.
• Phone: +32 89 32 76 33
• Email: marie-rose.vanhoestenberghe[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• Web Application
Parents receive a web application that offers information and support until the age of 2.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg, Schiepse Bos 6	Genk	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	KU Leuven, TRACE: Centre For Translational Psychological Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in DT-P	Distress Thermometer for Parents	2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Primary	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
Primary	WPPSI-III-NL	Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child	5 year
Secondary	Change in PNAR	Parent Newborn Attachment Relationship Questionnaire	2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year