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

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Other: Web Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prematurity, psychomotor development, parent empowerment, e-health, parental support, post discharge follow-up