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

NCT06200324 | Completed

• 1 other identifier: 2023.189
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

parenteral nutrition; premature infants; hydroelectrolytic disorders; plasma glucose concentration; anthropometric measurements

Outcome Measures

Primary Outcomes (6)

• Weight

  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

  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

  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

  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

  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

  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 Outcomes (3)

• Number of Participants with Electrolyte disorders

  Up to 14 days

• Number of Participants with Hyperglycemia

  Up to 14 days

• Number of Participants with 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.

Study Arms (2)

Ready-to-Use Parenteral Nutrition

Numeta G13E

Other: Ready-to-Use Parenteral Nutrition

Individualized parenteral nutrition

Individualized parenteral nutrition

Interventions

Ready-to-Use Parenteral Nutrition OTHER

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.

Also known as: Numeta G13E

Ready-to-Use Parenteral Nutrition

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (12)

• Rigo J, Marlowe ML, Bonnot D, Senterre T, Lapillonne A, Kermorvant-Duchemin E, Hascoet JM, Desandes R, Malfilatre G, Pladys P, Beuchee A, Colomb V. Benefits of a new pediatric triple-chamber bag for parenteral nutrition in preterm infants. J Pediatr Gastroenterol Nutr. 2012 Feb;54(2):210-7. doi: 10.1097/MPG.0b013e318232f915.

  PMID: 21866057 BACKGROUND

• Sirvent M, Calvo MV, Perez-Pons JC, Rodriguez-Penin I, Marti-Bonmati E, Vazquez A, Romero R, Crespo CL, Tejada P; Grupo de Nutricion Clinica de la SEFH. [Best practices for the safe use of parenteral nutrition multi-chamber bags. Spanish Society of Hospital Pharmacist's Clinical Nutrition Group]. Farm Hosp. 2014 Sep 16;38(5):389-97. doi: 10.7399/fh.2014.38.5.8085. Spanish.

  PMID: 25344132 BACKGROUND

• Mena KDR, Espitia OLP, Vergara JAD. Management of Ready-to-Use Parenteral Nutrition in Newborns: Systematic Review. JPEN J Parenter Enteral Nutr. 2018 Sep;42(7):1123-1132. doi: 10.1002/jpen.1165. Epub 2018 Apr 27.

  PMID: 29701872 BACKGROUND

• Kreissl A, Repa A, Binder C, Thanhaeuser M, Jilma B, Berger A, Haiden N. Clinical Experience With Numeta in Preterm Infants: Impact on Nutrient Intake and Costs. JPEN J Parenter Enteral Nutr. 2016 May;40(4):536-42. doi: 10.1177/0148607115569733. Epub 2015 Feb 5.

  PMID: 25655621 BACKGROUND

• Kriz A, Wright A, Paulsson M, Tomlin S, Simchowitz V, Senterre T, Shepelev J. Cost-Consequences Analysis of Increased Utilization of Triple-Chamber-Bag Parenteral Nutrition in Preterm Neonates in Seven European Countries. Nutrients. 2020 Aug 20;12(9):2531. doi: 10.3390/nu12092531.

  PMID: 32825528 BACKGROUND

• Wittwer A, Hascoet JM. Impact of introducing a standardized nutrition protocol on very premature infants' growth and morbidity. PLoS One. 2020 May 21;15(5):e0232659. doi: 10.1371/journal.pone.0232659. eCollection 2020.

  PMID: 32437423 RESULT

• Brennan AM, Kiely ME, Fenton S, Murphy BP. Standardized Parenteral Nutrition for the Transition Phase in Preterm Infants: A Bag That Fits. Nutrients. 2018 Feb 2;10(2):170. doi: 10.3390/nu10020170.

  PMID: 29393903 RESULT

• Riskin A, Shiff Y, Shamir R. Parenteral nutrition in neonatology--to standardize or individualize? Isr Med Assoc J. 2006 Sep;8(9):641-5.

  PMID: 17058418 RESULT

• Smolkin T, Diab G, Shohat I, Jubran H, Blazer S, Rozen GS, Makhoul IR. Standardized versus individualized parenteral nutrition in very low birth weight infants: a comparative study. Neonatology. 2010;98(2):170-8. doi: 10.1159/000282174. Epub 2010 Mar 16.

  PMID: 20234142 RESULT

• Díaz Cuesta, E., & Celis Castañeda, L. A. (2022). Prevalencia de la restricción de crecimiento extrauterino y factores de riesgo asociados en recién nacidos con peso menor de 1500 gramos en una unidad de cuidado intensivo neonatal de Bogotá (Colombia). Universitas Medica, 63(2). https://doi.org/10.11144/Javeriana.umed63-2.prce

  RESULT

• Osegueda-Mayen JR, Sarmiento-Aguilar A. Standarized parenteral nutrition in the NICU: Case Report and composition analysis of the three chamber bag. Acta Pediatr Mex. 2022;43(3):167-73.

  RESULT

• Setia MS. Methodology Series Module 1: Cohort Studies. Indian J Dermatol. 2016 Jan-Feb;61(1):21-5. doi: 10.4103/0019-5154.174011.

  PMID: 26955090 RESULT

MeSH Terms

Conditions

Hyperphagia; Premature Birth

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Adriana Ballesteros, MD

  Pediatra Neonatóloga FUNDACION VALLE DEL LILI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: January 11, 2024
• Study Start: March 1, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)