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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Infant Development Preterm Infant Feeding Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

The care providers who administered the parenteral (PN) solutions to the neonates were blinded to the identity of the PN solution.

Study Groups

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Nutrient estimation based on the actual weight (Control group)

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

Group Type SHAM_COMPARATOR

Control group

Intervention Type DIETARY_SUPPLEMENT

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

Nutrient estimations based on the corrected weight (Intervention group)

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

Group Type ACTIVE_COMPARATOR

Intervention Group

Intervention Type 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.

Interventions

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Intervention 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.

Intervention Type DIETARY_SUPPLEMENT

Control group

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes