Impact of Electrolyte Intake (Sodium, Phosphorus) on the Growth of Premature Newborns
NCT Number: NCT06506981
Acronym: ELECTROGRO
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Postnatal Growth Disorder
Sponsor: Central Hospital, Nancy, France
Sex: ALL
Age: CHILD
Enrollment: 684
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-06-30
Locations: Maternity Hospital CHRU, Nancy, Lorraine, 54035, France

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.

Primary Outcome Measures: 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: 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