RecruitingNot Applicable

Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality

France40 participantsStarted 2024-02-21

Plain-language summary

The aim of this study is to evaluate the impact of discharge from hospital with a weight of less than 2 kilos. To do this, the investigator will look at the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the neonatology department at the NOVO hospital between 2012 and 2024.

Who can participate

Age range

1 Month – 11 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: * Premature newborn baby (born at less than 37 days' gestation) * Newborn baby with IUGR (Intra-Uterine Growth Retardation) * Newborn baby hospitalised in the neonatology department of the NOVO hospital - Pontoise site * Patient born between 01/01/2012 and 31/12/2024. * Newborn who has left the neonatology department or the Kangaroo Unit to return home weighing less than 2 kg. * Newborn beneficiary of a social security scheme or entitled person. Exclusion Criteria: * Newborn transferred to another hospital before discharge. * Refusal by one of the parents. * Parent does not speak or understand French.

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

Observation of the short-term outcome of neonates discharged from the neonatology department hospital (Pontoise site) between 2012 and 2024 with a weight of less than 2 kilos.

Timeframe: At the end of the study, an average of 11 month

Trial details

NCT IDNCT06224764

SponsorHôpital NOVO

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

Contact for this trial

Maryline DELATTRE

+3333130754131 maryline.delattre@ght-novo.fr

View on ClinicalTrials.gov More Premature Birth trials