NCT07236957

Estimation of Nutritional Needs of Preterm Neonates Fed on Parenteral Nutrition and Effects on Body Weight Gain

Corrected Weight to the 10th Percentile vs. Actual Birth Weight for the Calculation of Nutritional Needs of Small for Gestational Age Neonates Fed on Parenteral Nutrition: a Randomized-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Panos Papandreou · Academic / Other
• Sex: All
• Age: 1 Day – 1 Day
• Healthy volunteers: Accepted

Summary

This randomized controlled trial included 100 preterm and small for gestational age neonates. The study aimed to determine the optimal approach for estimating nutritional needs in parenteral nutrition (PN) with the assistance of a specialized clinical decision support system (CDSS). More specifically, nutrient estimations based on the neonates' actual birth weight were compared to those calculated using the weight corresponding to the 10th percentile of the growth curve. The effect on growth outcomes over the PN course was investigated.

Detailed description

Background: Parenteral nutrition (PN) plays a crucial role in providing nutritional support to premature and small for gestational age neonates. Aim: In this randomized controlled study, we evaluated PN administration in preterm and small for gestational age neonates using the corrected weight estimated at the 10th percentile of the growth curve, as guided by a clinical decision support system (CDSS). Methods: A total of 100 preterm neonates were randomly assigned to either the Control group (n = 50) or the Intervention group (n = 50). Both groups received PN support using a specialized CDSS. In the Control group, the CDSS calculated the PN regimen based on the actual birth weight, whereas in the Intervention group, calculations were based on the corrected weight corresponding to the 10th percentile. Growth indicators (i.e., body weight, length, and head circumference) were measured at baseline and at the time of exclusive enteral feeding initiation. Blood samples were obtained at the last day of PN, after PN was ceased for 4 h and before oral feeding initiation. Electrolytes (sodium, potassium, calcium) and albumin concentrations, as well as red blood cells, white blood cells, haemoglobin and haematocrit were measured at the last day of PN.

Conditions

• Preterm Infant Development
• Preterm Infant Feeding Outcomes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intervention Group	In the Intervention group, the macronutrient composition in the parenteral nutrition solutions was calculated based on the corrected weight corresponding to the 10th percentile of the growth curve.
DIETARY_SUPPLEMENT	Control group	In the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight.

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-12-31
• Completion: 2024-05-31
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: Greece