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NCT Number: NCT07243054

Impact of Prepartum Intravenous Fluid Intake on Newborn Weight Loss in the First Days of Life

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Pierre TOURNEUX, PhD

CONTACT

[email protected]

+33322668652

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between maternal vascular fluid loading and newborn infant weight loss

    Time frame: 2 days

Secondary outcomes

  1. Correlation between maternal vascular fluid loading and respiratory distress

    Time frame: 2 days

  2. Correlation between maternal vascular fluid loading and jaundice of the newborn

    Time frame: 2 days

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Tourneux, Pr

CONTACT

[email protected]

33+3 22 08 76 04

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PERLE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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