NCT07243054

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

vascular fillingnewbornweight lossjaundicerespiratory distress

Outcome Measures

Primary Outcomes (1)

  • Correlation between maternal vascular fluid loading and newborn infant weight loss

    2 days

Secondary Outcomes (2)

  • Correlation between maternal vascular fluid loading and respiratory distress

    2 days

  • Correlation between maternal vascular fluid loading and jaundice of the newborn

    2 days

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMother over 18 years of age and newborn
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mother over 18 years of age and newborn

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Weight LossJaundiceDyspnea

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperbilirubinemiaPathologic ProcessesSkin ManifestationsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

March 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations