Department of Nutrition, IASO Hospital
Athens, Attica, 15123, Greece
NCT Number: NCT07236957
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.
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All sexes
Interventional
Not applicable
Athens, Attica, 15123, Greece
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
In the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight.
Time frame: 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).
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).
Panos Papandreou
Other
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
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