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

NCT06506981 | Completed

• 1 other identifier: 2024PI124
• Study Type: observational
• Target: 684
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postnatal Growth Disorder

Keywords

parenteral nutrition; enteral nutrition; electrolyte intake; premature newborn; growth trajectory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Sodium intake descriptive study

  30 days

• Phosphorus intake descriptive study

  30 days

• Protein intake descriptive study

  30 days

• Calories intake descriptive study

  30 days

• Weight growth descriptive study

  30 days

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternity Hospital CHRU

Nancy, Lorraine, 54035, France

Location

MeSH Terms

Conditions

Hyperphagia; Premature Birth

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pofessor

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 18, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

FR (1)