Impact of Prepartum Intravenous Fluid Intake on Newborn Weight Loss in the First Days of Life (NCT07243054) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Prepartum Intravenous Fluid Intake on Newborn Weight Loss in the First Days of Life
France200 participantsStarted 2025-03-01
Plain-language summary
At birth, the infant's weight was measured daily to assess the adequacy of nutritional intake. This indicator can be influenced by various factors related to the mother, her pregnancy, as well as medical interventions during the pre-delivery phase, such as pre-partum maternal fluid intakes, and the subsequent feeding method chosen for the newborn infant. This study aimed at exploring the association between maternal vascular fluid loading during labor in the pre-partum period and neonatal weight loss in the first two days of life. The study focuses on infants fedded with infant formula.
This observational, retrospective, single-center study was carried out at the Amiens University Hospital Center. The participants were mothers aged 18 and older, hospitalized in the maternity ward following full-term delivery (\> 37 weeks of gestation). Data were collected through the medical records of the patient and their newborn.
The investigators hypothesize that a relationship may exist between maternal pre-partum vascular fluid loading and neonatal weight loss in the first two days of life, in infants fed with infant formula. These results could raise awareness and help adapt medical and parental approaches to neonatal weight loss.
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Full-term delivery (≥37+0 SA)
* Singleton pregnancy
* Mother over 18 years of age
* Infant formula feeding exclusively in the maternity ward for the first 2 days
Exclusion Criteria:
* Mother under guardianship
* Mother who does not understand French
* Mother objecting to her personal data being reused for research purposes
* Incomplete or incorrectly completed patient medical record
* Mixed or exclusive breastfeeding
* Mother presenting a hemodynamic disorder in the 12 hours preceding delivery, requiring a filling specifically for this reason
* Child with renal pathology or uropathy
* Children with cleft lip, palate or labio-palate
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
1
Correlation between maternal vascular fluid loading and newborn infant weight loss