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

NCT06200324 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 284

Last updated 2024-01-11

No results posted yet for this study

Summary

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.

Conditions

  • Very Low Birth Weight Infant

Interventions

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.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Fundacion Clinica Valle del Lili

    lead OTHER

Principal Investigators

  • Adriana Ballesteros, MD · Pediatra Neonatóloga FUNDACION VALLE DEL LILI

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06200324 on ClinicalTrials.gov