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| Name | Class |
|---|---|
| University of Peloponnese | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, IASO Hospital | Athens | Attica | 15123 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23601190 | Background | 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. | |
| 41654298 | Derived | Papandreou P, Foscolou A, Bampoukli E, Gioxari A. Parenteral nutrition using corrected weight to the 10th percentile improves weight gain in preterm neonates: A randomized controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102960. doi: 10.1016/j.clnesp.2026.102960. Epub 2026 Feb 5. |
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The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to their containing information that could compromise the privacy of the research participants.
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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.
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The care providers who administered the parenteral (PN) solutions to the neonates were blinded to the identity of the PN solution.
| Control group | Dietary Supplement | In the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight. |
|
| D001835 | Body Weight |
| D008722 | Methods |