Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023 (NUMETA)

December 27, 2023 updated by: Adriana Ballesteros, Fundacion Clinica Valle del Lili

Clinical Outcomes of the Use of Ready-to-Use Parenteral Nutrition in Very Low Birth Weight Newborns in a Fourth-level Neonatal Intensive Care Unit in Cali, Colombia, March 2017-March 2023

The proposed study aims to assess the clinical outcomes of using ready-to-use parenteral nutrition, specifically Numeta G13E, compared to individualized parenteral nutrition in neonates with very low birth weight. Conducted in a level 4 neonatal intensive care unit from March 2017 to March 2023, the study focuses on growth parameters (weight, head circumference, height), growth velocity, and the incidence of complications. The retrospective open-cohort observational design involves a sample of 284 infants, 142 in each group, considering a 95% confidence level and 80% power. The study addresses the need for a local evaluation of the efficacy of ready-to-use parenteral nutrition in this vulnerable population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction:

Parenteral nutrition enhances nutrition in very low birth weight newborns (<1500 g) who, due to gastrointestinal immaturity, experience delays in obtaining adequate nutrients enterally. Parenteral nutrition (PN) promotes better growth in all anthropometric variables in this population.

However, complications associated with its use have been documented. A commercial method developed to reduce these complications is ready-to-use parenteral nutrition, a three-chamber bag providing a complete mix of nutrients, offering immediate access, quicker initiation of nutrition, and prescription homogenization. These factors aim to achieve better metabolic stability, improved nutritional intake, and weight, height, and head circumference gain.

This study aims to evaluate outcomes with the initiation of ready-to-use parenteral nutrition.

Theoretical Framework:

Advances in favorable clinical outcomes for preterm newborns result from multiple interventions such as cardiorespiratory support and early infection identification. Despite these efforts, morbidity and mortality outcomes remain stagnant. Optimizing nutritional coverage, especially in preterm infants, is one of the objectives to improve outcomes.

Premature infants, due to their immaturity and typically critical clinical condition, require early initiation of parenteral nutrition to guarantee their nutritional needs and reduce the possibility of extrauterine growth restriction. There is also an association between early protein and energy intake and improved neurodevelopment.

While the benefits of early parenteral nutrition initiation in preterm infants are evident, it is classified as a high-risk medication due to potential errors in preparation, leading to biochemical alterations and infection risk. Standardized ready-to-use nutrition is considered a safe alternative, particularly in institutions with limited technological resources.

Commercial preparations like Numeta 13% meet the requirements recommended by the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) for very low birth weight neonates (<1500 g) and extremely low birth weight preterm infants (<1000 g), presenting a cost-effective alternative to individualized preparations.

Despite the proven need for early parenteral nutrition in critically ill neonates, studies reveal variations in protocol adherence, with a significant percentage of units initiating late protein intake and low energy content. Institutional protocols and software utilization could address these challenges.

Continued controversy exists regarding the optimal composition of parenteral nutrition. While individualized nutrition allows adjustments, especially in preterm infants prone to electrolyte imbalances and metabolic control issues, ready-to-use preparations, though less tailored, show no significant differences in complications.

A proposed cohort study aims to assess significant differences between preterm infants receiving individualized and ready-to-use parenteral nutrition locally.

Justification for the Study:

Very low birth weight newborns require multiple supports, including thermal, respiratory, hemodynamic, and nutritional. Ready-to-use parenteral nutrition, with its immediate availability and standardized composition, reduces infection risks.

This study aims to compare clinical outcomes between individualized and ready-to-use parenteral nutrition in terms of metabolic stability, infections, and growth in preterm infants. Existing studies highlight growth delays in preterm infants, associated with poor neurodevelopment and future metabolic and cardiovascular complications. Early trophic stimulation, supported by parenteral nutrition, facilitates a smooth transition with adequate nutrient supply, aiming for appropriate weight gain.

Recognized publications such as ESPGHAN and NICE endorse the use of ready-to-use parenteral nutrition for its safety, immediate availability, and suitability for approximately 85% of patients. Only the remaining 15% may require individual adjustments for specific metabolic issues. An analytical study as proposed would allow local insights into clinical outcomes in neonates receiving individualized vs. ready-to-use parenteral nutrition.

Research Question:

What are the clinical outcomes of using ready-to-use parenteral nutrition compared to individualized parenteral nutrition in very low birth weight neonates in a level 4 Neonatal Intensive Care Unit during the period March 2017-March 2023?

Research Hypotheses:

Alternative Hypothesis: There are differences in anthropometric measurements and complication incidence between very low birth weight patients receiving individualized parenteral nutrition and Numeta G13E ready-to-use.

Null Hypothesis: There are no differences in anthropometric measurements and complication incidence between very low birth weight patients receiving individualized parenteral nutrition and Numeta G13E ready-to-use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia
        • Fundación Valle del Lili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Very low birth weight neonates exposed to individualized or ready-to-use parenteral nutrition in a level 4 neonatal intensive care unit during the period from March 2017 to March 2023.

Description

Inclusion Criteria:

  • Newborns admitted to the neonatal intensive care unit between March 2017 and March 2023
  • Requirement for Parenteral Nutrition.
  • Birth weight less than 1500 grams (very low birth weight).

Exclusion Criteria:

  • Patients transferred from another hospital with more than 24 hours of life.
  • Incomplete follow-up (until 36 weeks corrected age or discharge).
  • Major congenital anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ready-to-Use Parenteral Nutrition
Numeta G13E
Other: Ready-to-Use Parenteral Nutrition

In newborns weighing less than 1000 grams, parenteral nutrition is initiated at volumes of 70-80 ml/kg/day up to a maximum volume of 128 ml/kg/day, with a provision of 4 grams/kg/day of protein and a metabolic rate of 12 mg/kg/minute.

For newborns weighing between 1001-1500 grams, parenteral nutrition is initiated at volumes of 70-80 ml/kg/day up to a maximum of 110 ml/kg/day.

When enteral intake exceeds 70 ml/kg/day, a gradual decrease in the volume of parenteral nutrition is initiated. We discontinue parenteral nutrition in newborns weighing less than 1000 grams with enteral volume of 120 ml/kg/day, and for those between 1000 grams and 1500 grams, enteral nutrition volume of 100 ml/kg/day.

Other Names:
  • Numeta G13E
Individualized parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Weight in grams
36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Head circumference
Time Frame: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Circumference in centimeters
36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Length
Time Frame: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Length in centimeters
36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Growth velocity - Height
Time Frame: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Length in centimeters gained per unit of time
36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Growth velocity - Weight
Time Frame: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Weight in grams gained per unit of time
36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Growth velocity - Head circumference
Time Frame: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Head Circumference in centimeters gained per unit of time
36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Electrolyte disorders
Time Frame: Up to 14 days
Highest serum levels
Up to 14 days
Number of Participants with Hyperglycemia
Time Frame: Up to 14 days
Highest serum glucose level
Up to 14 days
Number of Participants with Bloodstream infections
Time Frame: 36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.
Bloodstream infections
36 weeks corrected gestational age or at the time of discharge of the Neonatal Intensive Care Unit (NICU), whichever came first, assessed through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Clinica Valle del Lili

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adriana Ballesteros, MD, Pediatra Neonatóloga FUNDACION VALLE DEL LILI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No, due to confidentiality issues.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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