Vascular FillingPERLENCT07243054
Impact of Prepartum Intravenous Fluid Intake on Newborn Weight Loss in the First Days of Life
An observational study of Vascular Filling and Newborn, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vascular Filling, Newborn, Weight Loss
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Mother over 18 years of age and newborn
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Pierre TOURNEUX, PhD, +33322668652, tourneux.pierre@chu-amiens.fr
About this study
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.
- Conditions
- Vascular Filling, Newborn, Weight Loss, Jaundice, Respiratory Distress
- Keywords
- vascular filling, newborn, weight loss, jaundice, respiratory distress
- Medical subject headings
- Weight Loss, Jaundice, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between maternal vascular fluid loading and newborn infant weight loss
Measured: 2 days
Secondary outcomes (2)
Correlation between maternal vascular fluid loading and respiratory distress
Measured: 2 days
Correlation between maternal vascular fluid loading and jaundice of the newborn
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Mar 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular FillingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243054
- Sponsor's protocol ID
- PI2025_843_0037
- Acronym
- PERLE
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prepartum Intravenous Fluid Intake on Newborn Weight Loss in the First Days of Life
- ClinicalTrials.gov ID
- NCT07243054
- Acronym / sponsor ID
- PERLE / PI2025_843_0037
- Conditions
- Vascular Filling, Newborn, Weight Loss, Jaundice, Respiratory Distress
- Keywords
- vascular filling, newborn, weight loss, jaundice, respiratory distress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mother over 18 years of age and newborn
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between maternal vascular fluid loading and newborn infant weight loss
Time frame: 2 days
2 secondary outcomes
Correlation between maternal vascular fluid loading and respiratory distress
Time frame: 2 days
Correlation between maternal vascular fluid loading and jaundice of the newborn
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Filling and Newborn, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Tourneux, Pr (33+3 22 08 76 04, Tourneux.Pierre@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between maternal vascular fluid loading and newborn infant weight loss (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.