Supporting parents of preterm infants with digital informatio

Not Applicable

• Conditions: Preterm-born infants and their parents; Pregnancy and Childbirth

• Registration Number: ISRCTN65709138
• Lead Sponsor: Amsterdam UMC Location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-07
• Last Update Posted: 21 November 2022
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. VP infant, with a gestational age <32 weeks and/or birthweight <1500 grams who is enrolled in the TOP program.
2. MP infant with a gestational age between 32 and 34 weeks and a birthweight >1500 grams, within two weeks post-discharge.
3. In each group, at least 15 infants from families with low health literacy will be included. Low health literacy is defined as level of education MBO-2 or less or less than 10 years of education in another country.

Exclusion Criteria

1. Severe congenital malformations or syndromes
2. Recent surgical intervention
3. Severe psychiatric maternal problems
4.. Support by a paediatric physical therapist in the post-discharge period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The use of the E-TOP module, the frequency and duration, will be quantified by online user-data during 6 months. Parental and interventionists experiences will be assessed using questionnaire and semi-structured interviews with parents and TOP interventionists at 6 months. The questionnaire will be composed for the E-TOP module, based on questionnaires measuring parental experiences with app use.<br> 2. For moderate preterm infants, the number of home visits per infant, the duration and content of the home visits will be assessed using a checklist filled in by the interventionist after each home visit. Parental and interventionists experiences will be assessed using questionnaire and semi-structured interviews with parents and TOP interventionists at 6 months. The questionnaire will be composed for this intervention, based on questionnaires measuring parental experiences with intervention.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Parenting self-efficacy measured using the questionnaire Maternal Self-Efficacy in the Nurturing Role (SENR) at baseline and 6 months.<br> 2. Parental mentalizing measured using the questionnaire Parental Reflective Functioning Questionnaire (PRFQ) at baseline and 6 months.<br> 3. Parent-infant interaction using a videotaped observation, scored with The Massie-Campbell Scale of Mother-infant Attachment indicators During Stress (ADS) at baseline and 6 months.<br> 4. Socio-emotional development of the infants measured using the questionnaire the Ages and Stages Questionnaire: Socio-Emotional, Second Edition (ASQ:SE-2) at 6 months.<br> 5. Motor development measured using the Alberta Infant Motor Scale (AIMS) is an observational motor assessment administered by a pediatric physical therapist at 6 months.<br>