Very Low Birth Weight InfantNUMETANCT06200324
Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023
An observational study of Very Low Birth Weight Infant, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- Ready-to-Use Parenteral Nutrition
- How many people
- 284 participants
- Where
- 1 siteColombia
- Study dates
- 1 Mar 2017to 31 Mar 2023
- Phase
- Observational
- 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 Up to 24 hours
- All sexes
- Child
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Very Low Birth Weight Infant
- Being tested
- Ready-to-Use Parenteral Nutrition
- Keywords
- parenteral nutrition, premature infants, hydroelectrolytic disorders, plasma glucose concentration, anthropometric measurements
- Medical subject headings
- Hyperphagia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready-to-Use Parenteral NutritionOther
Also called Numeta G13E
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.
| Study group | Role | What they receive |
|---|---|---|
| Ready-to-Use Parenteral Nutrition | Numeta G13E Receives: Other: Ready-to-Use Parenteral Nutrition | |
| Individualized parenteral nutrition | Individualized parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight in grams
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Highest serum levels
Measured: Up to 14 days
Number of Participants with Hyperglycemia
Highest serum glucose level
Measured: Up to 14 days
Number of Participants with Bloodstream infections
Bloodstream infections
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Mar 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinica Valle del Lili
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Adriana Ballesteros, Fundacion Clinica Valle del Lili
- Investigators
- Adriana Ballesteros, MD, Principal investigator, Pediatra Neonatóloga FUNDACION VALLE DEL LILI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200324
- Sponsor's protocol ID
- 2023.189
- Acronym
- NUMETA
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, due to confidentiality issues.
Publications
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.
PubMed 21866057Sirvent 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.
PubMed 25344132Mena 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.
PubMed 29701872Kreissl 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.
PubMed 25655621Kriz 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.
PubMed 32825528Wittwer 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.
PubMed 32437423Brennan 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.
PubMed 29393903Riskin A, Shiff Y, Shamir R. Parenteral nutrition in neonatology--to standardize or individualize? Isr Med Assoc J. 2006 Sep;8(9):641-5.
PubMed 17058418Smolkin 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.
PubMed 20234142Díaz 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
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.
Setia MS. Methodology Series Module 1: Cohort Studies. Indian J Dermatol. 2016 Jan-Feb;61(1):21-5. doi: 10.4103/0019-5154.174011.
PubMed 26955090
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06200324
- Acronym / sponsor ID
- NUMETA / 2023.189
- Conditions
- Very Low Birth Weight Infant
- Keywords
- parenteral nutrition, premature infants, hydroelectrolytic disorders, plasma glucose concentration, anthropometric measurements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Fundacion Clinica Valle del LiliUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 11 Jan 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ready-to-Use Parenteral Nutrition | – | Other: Ready-to-Use Parenteral NutritionNumeta G13E |
| Individualized parenteral nutrition | – | –Individualized parenteral nutrition |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Ready-to-Use Parenteral NutritionAlso: Numeta G13EIn 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 | Ready-to-Use Parenteral Nutrition |
Primary outcome
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
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
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
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
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
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
3 secondary outcomes
Number of Participants with Electrolyte disorders
Time frame: Up to 14 days
Number of Participants with Hyperglycemia
Time frame: 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.
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 11 Jan 2024.
- Background: PubMed 21866057Rigo 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.
- Background: PubMed 25344132Sirvent 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.
- Background: PubMed 29701872Mena 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.
- Background: PubMed 25655621Kreissl 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.
- Background: PubMed 32825528Kriz 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.
- Results publication: PubMed 32437423Wittwer 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.
- Results publication: PubMed 29393903Brennan 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.
- Results publication: PubMed 17058418Riskin A, Shiff Y, Shamir R. Parenteral nutrition in neonatology--to standardize or individualize? Isr Med Assoc J. 2006 Sep;8(9):641-5.
- Results publication: PubMed 20234142Smolkin 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.
- Results publicationDíaz 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
- Results publicationOsegueda-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.
- Results publication: PubMed 26955090Setia MS. Methodology Series Module 1: Cohort Studies. Indian J Dermatol. 2016 Jan-Feb;61(1):21-5. doi: 10.4103/0019-5154.174011.
- 2000 - 2020 - 20 Years of Innovation that have marked the WorldLink provided by the sponsor.
- Individual participant dataSharing planned: No. No, due to confidentiality issues.
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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.
Adriana Ballesteros, MD principal investigator
Pediatra Neonatóloga FUNDACION VALLE DEL LILI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birth Weight Infant, run by Fundacion Clinica Valle del Lili at 1 site in Colombia.
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 3 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 11 Jan 2024. 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 Colombia. 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. 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?
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.). The study lists 6 primary outcomes in all. 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 NCT06200324, which also lists 12 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 11 Jan 2024.