Clinical trial NCT06506981: Impact of Electrolyte Intake (Sodium, Phosphorus) on the Growth of Premature Newborns
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postnatal Growth Disorder
Keywords: parenteral nutrition
enteral nutrition
electrolyte intake
premature newborn
growth trajectory
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 684
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Observational model: COHORT
Time perspective: OTHER
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Relationship between electrolyte intake (sodium and phosphorus) and the occurrence of Growth retardation (EUGR) in preterm neonates
timeFrame: 30 days
Secondary outcomes:
measure: Sodium intake descriptive study
timeFrame: 30 days
measure: Phosphorus intake descriptive study
timeFrame: 30 days
measure: Protein intake descriptive study
timeFrame: 30 days
measure: Calories intake descriptive study
timeFrame: 30 days
measure: Weight growth descriptive study
timeFrame: 30 days
measure: Weight growth according to reference curve for the population
timeFrame: 30 days
measure: Relationship between sodium intake and the occurrence of EUGR in preterm neonates after adjusting on protein and calorie intake
timeFrame: 30 days
measure: Relationship between phosphorus intake and the occurrence of EUGR in preterm neonates after adjusting on protein and calorie intake
timeFrame: 30 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternity Hospital CHRU
state: Lorraine
Study officials:
References: