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

Panos Papandreou

Status: Completed

Conditions: Preterm Infant Feeding Outcomes; Preterm Infant Development

Treatments: Dietary Supplement: Intervention Group; Dietary Supplement: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT07236957

21-11-18AB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 1 to 1 day old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Nutrient estimation based on the actual weight (Control group)

Sham Comparator group

Description:

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

Treatment:

Dietary Supplement: Control group

Nutrient estimations based on the corrected weight (Intervention group)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Intervention Group