An observational study in Postnatal Growth Disorder, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Central Hospital, Nancy, France · Observational
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 684 is above the median of 112 across 777 observational studies indexed under Premature Birth.
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All premature neonates born between January 1st 2023 and December 31st 2023 who were hospitalized at the Nancy Maternity Hospital in Neonatology
Exclusion Criteria:
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).
Time frame: 30 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
Weight growth according to reference curve for the population
Weight trajectory according to Fenton reference curves in z-score
Time frame: 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
Time frame: 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
Time frame: 30 days
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France