Skip to main content
OpenTrials
Completed

NCT Number: NCT06506981

Impact of Electrolyte Intake (Sodium, Phosphorus) on the Growth of Premature Newborns

Extrauterine growth restriction (EUGR) is a common complication in the medical management of premature newborns. The long-term consequences of EUGR are weight and height restriction, metabolic disorders, and neurodevelopmental disorders. The main risk factor for EUGR is nutritional deficiency, particularly protein and energy. Additionally, appropriate intakes of electrolytes, particularly sodium and phosphorus, are essential to promote harmonious growth. Adequate sodium intake is essential to ensure satisfactory growth, especially in premature babies due to their higher body water content. Adequate phosphorus intake is also essential because of its involvement in the formation of lean mass, with sufficient protein intake, and in phosphocalcic metabolism.

At the Regional University Maternity of Nancy, parenteral and enteral nutrition prescriptions for each premature newborn are made using the Logipren® prescription assistance software, based on ESPGHAN recommendations. Despite this theoretical security, it seems that they are not strictly respected. At the same time, premature newborns typically show weight loss often greater than -1 z-score.

The objective of this research is to study the impact of electrolyte intake (sodium and phosphorus) on growth trajectories and the incidence of EUGR in premature newborns discharged from the Nancy Maternity Hospital in 2023. The secondary criteria are to describe sodium, phosphorus, protein and calorie intake and compliance with ESPGHAN recommendations; assess the true prevalence of stunting in our study population; and the impact of meeting electrolyte intake recommendations on children's growth trajectory, taking into account protein and calorie intake.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

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

Inclusion criteria

  • Neonates born between January 1st 2023 and December 31st 2023
  • Neonates born before 37 SA
  • Neonates hospitalized at the Nancy Maternity Hospital in Neonatology

Exclusion criteria

  • Neonates transferred at the Nancy Maternity Hospital after 48 first hours of life

Treatment and study plan

Primary outcomes

  1. Relationship between electrolyte intake (sodium and phosphorus) and the occurrence of Growth retardation (EUGR) in preterm neonates

    Time frame: 30 days

    Sodium and phosphorus intake according to the recommendations of the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) for parenteral nutrition. The hypothesis is that electrolyte intakes lower than the ESPGHAN recommendation should induce an EUGR defined as a loss of one standard deviation according to the reference growth curves (Fenton reference).

Secondary outcomes

  1. Sodium intake descriptive study

    Time frame: 30 days

    Total daily sodium intake, in mmol/Kg/d, during the first 30 days, or up to the date of discharge if before 30 days, according to ESPGHAN recommendations for parenteral nutrition.

  2. Phosphorus intake descriptive study

    Time frame: 30 days

    Total daily phosphorus intake, in mmol/Kg/d, during the first 30 days, or up to the date of discharge if before 30 days, according to ESPGHAN recommendations for parenteral nutrition.

  3. Protein intake descriptive study

    Time frame: 30 days

    Total daily protein intake, in g/Kg/d, during the first 30 days, or up to the date of discharge if before 30 days, according to ESPGHAN recommendations for parenteral nutrition.

  4. Calories intake descriptive study

    Time frame: 30 days

    Total daily calories intake, in kCal/Kg/d, during the first 30 days, or up to the date of discharge if before 30 days, according to ESPGHAN recommendations for parenteral nutrition.

  5. Weight growth descriptive study

    Time frame: 30 days

    Daily weight trajectory in grams/Kg/d during the first 30 days or up to the date of discharge if before 30 days.

  6. Weight growth according to reference curve for the population

    Time frame: 30 days

    Weight trajectory according to Fenton reference curves in z-score

  7. Relationship between sodium intake and the occurrence of EUGR in preterm neonates after adjusting on protein and calorie intake

    Time frame: 30 days

    Correlation between eletrolyte intake and growth trajectory

  8. Relationship between phosphorus intake and the occurrence of EUGR in preterm neonates after adjusting on protein and calorie intake

    Time frame: 30 days

    Correlation between eletrolyte intake and growth trajectory

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Association Between Electrolyte Intake and Growth Trajectories in Premature Newborns : a Retrospective Population-based Study Between January 2023 and December 2023 at the Regional Maternity Hospital of Nancy

Acronym: ELECTROGRO

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

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.

Published trials that share one or more normalized conditions with this study.