Preterm Infant Development, Preterm Infant Feeding Outcomes
Conditions
Keywords
preterm neonates, parenteral nutrition, clinical decision support system, weight gain
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.
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.
Interventions
DIETARY_SUPPLEMENTIntervention 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_SUPPLEMENTControl group
In the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight.
Sponsors
University of Peloponnese
Panos Papandreou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)
Masking description
The care providers who administered the parenteral (PN) solutions to the neonates were blinded to the identity of the PN solution.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Days
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight change | 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). |
Countries
Greece
Outcome results
None listed