Not Yet RecruitingNot Applicable

Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study

Germany100 participantsStarted 2025-09-01

Plain-language summary

This study aims to explore parents' experiences and emotional burdens related to their newborn's hospital stay using an online survey. Our target population consists of parents of newborns born preterm, with low birthweight, or critically ill. Particularly the presence of infant- and family-centred developmental care (IFCDC) principles as well as support through political framework conditions will be investigated.

Who can participate

Age range

18 Years

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: Parent or caregiver of a newborn infant born on January 1, 2023, or thereafter, who received/is receiving special/intensive care starting within the first week of life such as oxygen therapy or other respiratory support, incubator treatment, intravenous infusions, treatment of (suspected) sepsis, pneumonia, necrotising enterocolitis, malformations, jaundice, nutritional/feeding problems, hypoglycemia, etc. Exclusion Criteria: * Other family members than parents/(primary) caregivers * Parents of newborns that did not receive special/intensive care starting within the first week of life * Parents or caregivers of infants born before 1 January 2023 * Persons with insufficient proficiency of one of the languages of the questionnaire

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

Infant Family-Centered Developmental Care principles

Timeframe: 01/09/2025 - 31/12/2027

Trial details

NCT IDNCT06827028

SponsorGlobal Foundation for the Care of Newborn Infants

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-31

Contact for this trial

Julia Hoffmann, Dr

+49 89 89 0 83 260 julia.hoffmann@gfcni.org

View on ClinicalTrials.gov More Infant, Premature trials