UnknownNot Applicable

Parental Participation on the Neonatal Ward - the neoPARTNER Study

Netherlands613 participantsStarted 2022-03-07

Plain-language summary

Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for \>7 days as compared to standard medical rounds (SMR) without parents as part of standard neonatal care (SNC).

Who can participate

Age range

1 Day

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infant requiring hospital admission directly (within 24 hours) after birth; * Parent of 18 years or older; * Written informed consent of both parents. Exclusion Criteria: * Infant's hospital stay shorter than 7 days; * Infant with severe congenital or syndromal anomaly; * Infant with critical illness who is unlikely to survive; * Parent with current psychosocial problems (such as posttraumatic stress disorder, schizophrenia or psychotic disorders) with or without medication which have not been stable over the past year; * Involvement of child protective services in the family; * Parent not able or not willing to fill out questionnaires in English or Dutch.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of parental stress

Timeframe: Immediately after intervention (at discharge of the infant)

Trial details

NCT IDNCT05343403

SponsorOnze Lieve Vrouwe Gasthuis

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-02

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