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

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

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.

Study Overview

• Status: Completed
• Conditions: Postnatal Growth Disorder

• Study Type: Observational
• Enrollment (Actual): 684

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54035
      • Maternity Hospital CHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All premature neonates born between January 1st 2023 and December 31st 2023 who were hospitalized at the Nancy Maternity Hospital in Neonatology

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between electrolyte intake (sodium and phosphorus) and the occurrence of Growth retardation (EUGR) in preterm neonates	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).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sodium intake descriptive study	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.	30 days
Phosphorus intake descriptive study	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.	30 days
Protein intake descriptive study	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.	30 days
Calories intake descriptive study	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.	30 days
Weight growth descriptive study	Daily weight trajectory in grams/Kg/d during the first 30 days or up to the date of discharge if before 30 days.	30 days
Weight growth according to reference curve for the population	Weight trajectory according to Fenton reference curves in z-score	30 days
Relationship between sodium intake and the occurrence of EUGR in preterm neonates after adjusting on protein and calorie intake	Correlation between eletrolyte intake and growth trajectory	30 days
Relationship between phosphorus intake and the occurrence of EUGR in preterm neonates after adjusting on protein and calorie intake	Correlation between eletrolyte intake and growth trajectory	30 days

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: enteral nutrition; parenteral nutrition; premature newborn; electrolyte intake; growth trajectory
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Growth Disorders
• Other Study ID Numbers: 2024PI124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No