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

NCT07236957 | Completed

• 1 other identifier: 21-11-18AB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Infant Development; Preterm Infant Feeding Outcomes

Keywords

preterm neonates; parenteral nutrition; clinical decision support system; weight gain

Outcome Measures

Primary Outcomes (1)

• Body weight change

  The primary outcome is to detect a statistical significant difference in body weight increase between the control and the intrevention group at the last day of parenteral nutrition support (study endpoint).

  From birth day (day 1) till the last day of parenteral nutrition support (study endpoint). Each neonate had different PN duration according to their clinical status (average 12 days).

Study Arms (2)

Nutrient estimation based on the actual weight (Control group)

SHAM COMPARATOR

In the Control group, the clinical decision support system was used to determine parenteral nutriton requirements.

Dietary Supplement: Control group

Nutrient estimations based on the corrected weight (Intervention group)

ACTIVE COMPARATOR

In the Intervention group, the clinical decision support system was used to determine parenteral nutrition requirements.

Dietary Supplement: Intervention Group

Interventions

Intervention Group DIETARY_SUPPLEMENT

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.

Nutrient estimations based on the corrected weight (Intervention group)

Control group DIETARY_SUPPLEMENT

In the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight.

Nutrient estimation based on the actual weight (Control group)

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• preterm neonates hospitalized in NICU and meeting the criteria for small for gestational age infants, i.e., neonates with birth weight under the 10th percentile,
• preterm neonates receiving exclusive parenteral nutrition, and
• parents' written consent for study participation.

You may not qualify if:

• term birth newborns or newborns not fullfilling the criteria of small for gestational age infants,
• newborns with primary liver/bile duct disease,
• newborns receiving enteral nutrition, and/or
• neonates whose parents did not give a written consent to participate in the study

Sponsors & Collaborators

• Panos Papandreou: lead
• University of Peloponnese: collaborator

Study Sites (1)

Department of Nutrition, IASO Hospital

Athens, Attica, 15123, Greece

Location

Related Publications (1)

• Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.

  PMID: 23601190 BACKGROUND

MeSH Terms

Conditions

Hyperphagia; Weight Gain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The care providers who administered the parenteral (PN) solutions to the neonates were blinded to the identity of the PN solution.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Pharmacologist

Model Details: A total of 100 preterm and small for gestational age neonates were randomly assigned to either the Control group (n = 50) or the Intervention group (n = 50). Both groups received parenteral nutrition (PN) supported by a specialized clinical decision support system. In the Control group, the PN regimen was based on the actual birth weight, whereas in the Intervention group, calculations were based on the corrected weight corresponding to the 10th percentile of the growth curve.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)