Preterm Infant DevelopmentNCT07236957
Estimation of Nutritional Needs of Preterm Neonates Fed on Parenteral Nutrition and Effects on Body Weight Gain
A study testing Intervention Group in people with Preterm Infant Development and Preterm Infant Feeding Outcomes, run by Panos Papandreou at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant Development, Preterm Infant Feeding Outcomes
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Intervention Group, Control group
- Keywords
- preterm neonates, parenteral nutrition, clinical decision support system, weight gain
- Medical subject headings
- Hyperphagia, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupDietary 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.
Control groupDietary supplement
In the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Control group |
| 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. Receives: Dietary Supplement: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panos Papandreou
- Sponsor type
- University, hospital or other
- Collaborators
- University of Peloponnese
- Responsible party
- Sponsor-investigator, Panos Papandreou, Iaso Maternity Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236957
- Sponsor's protocol ID
- 21-11-18AB
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 23601190Papandreou 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.
PubMed 41654298
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07236957
- Acronym / sponsor ID
- 21-11-18AB
- Keywords
- preterm neonates, parenteral nutrition, clinical decision support system, weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Panos PapandreouUniversity, hospital or other
- Collaborators
- University of Peloponnese
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutrient estimation based on the actual weight (Control group) | Sham comparator | Dietary Supplement: Control groupIn 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 | Dietary Supplement: Intervention GroupIn the Intervention group, the clinical decision support system was used to determine parenteral nutrition requirements. |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupIn 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 supplement | Nutrient estimations based on the corrected weight (Intervention group) |
| Control groupIn the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight. | Dietary supplement | Nutrient estimation based on the actual weight (Control group) |
Primary outcome
Body weight change
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 23601190Fenton 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.
- Derived from this study: PubMed 41654298Papandreou 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Preterm Infant Development and Preterm Infant Feeding Outcomes, run by Panos Papandreou at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236957, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.