NCT03693287

Brief Summary

Preterm infants (gestational age between 189 and 258 days) with a birth weight (BW) greater than 1250 grams will be randomized to personalized-parenteral nutrition (P-PN) or standardized-parenteral nutrition (S-PN). The aim of the study is to evaluate the effect of S-PN versus P-PN on growth of preterm infants with BW\>1250 grams.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2021

Typical duration for phase_4

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
2.8 years until next milestone

Study Start

First participant enrolled

July 4, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

September 26, 2018

Last Update Submit

March 22, 2023

Conditions

Infant,PrematureParenteral NutritionGrowth

Keywords

PretermInfantParenteral NutritionGrowth

Outcome Measures

Primary Outcomes (1)

  • WEIGHT CHANGE

    Daily weight change (g/kg/d) during parenteral nutrition (PN)

    From the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). At least 7 days of PN will be required to calculate weight gain during PN.

Secondary Outcomes (32)

  • MUSCLE ULTRASOUND (optional)

    At the start of PN, after 7, 14 and 28 days (+-1 d).

  • ADIPOSE TISSUE ULTRASOUND (optional)

    At the start of PN, after 7, 14 and 28 days (+-1 d).

  • BONE ULTRASOUND (optional)

    At the start of PN, after 7, 14 and 28 days (+-1 d).

  • WEIGHT

    Daily up to 42 weeks of post menstrual age or discharge if it comes first.

  • TOTAL BODY LENGTH

    Weekly up to 42 weeks of post menstrual age or discharge if it comes first.

  • +27 more secondary outcomes

Study Arms (2)

Personalized-Parenteral Nutrition (P-PN)

ACTIVE COMPARATOR

These patients will receive personalized parenteral nutrition (PN) as it is customary in the participating centers. Dosing range: glucose from 9 to 13 g/kg/d, AA from 2.0 to 3.0 g/kg/d, and FAT from 1.5 to 2.5 g/kg/d. Intravenous macronutrient intakes: * PN day 1: 2.0 g/kg of AA, 1.6 g/kg of FAT and 9 g/kg of glucides. * PN day 2: 2.5 g/kg of AA, 2.0 g/kg of FAT and 11 g/kg of glucides. * PN day 3 and the days after: 3.0 g/kg of AA, 2.5 g/kg of FAT and 13 g/kg of glucides. Intravenous vitamins will be supplied according to local clinical practice. Variations in macronutrient intakes will be tolerated within ±20%. Nutritional goal: to ensure at least 2.5 g/kg/d of AA and 70 kcal/kg/d of no protein energy (NPE) from PN day 2.

Drug: Personalized-parenteral nutrition (P-PN)

Standardized-Parenteral Nutrition (S-PN)

EXPERIMENTAL

These patients will receive standardized parenteral nutrition (PN) by using a triple chamber bag (Numeta G13%E®). Dosing range: 80-300 ml/d. Intravenous macronutrient intakes: 65 ml/kg at PN day 1, 80 ml/kg at PN day 2 and then 100 ml/kg from PN day 3. Nutritional goal: to ensure at least 2.5 g/kg/d of amino acids (AA) and 70 kcal/kg/d of no protein energy (NPE) from PN day 2.

Drug: Standardized-parenteral nutrition (S-PN)

Interventions

Standardized-parenteral nutrition (S-PN)DRUG

NUMETA G13%E 300 mL is a triple-chamber (lipid emulsion, amino acids solution with electrolytes, and glucose solution), ready-to-use parenteral nutrition product available to treat preterm infants (less than 37 weeks gestational age).

Standardized-Parenteral Nutrition (S-PN)
Personalized-parenteral nutrition (P-PN)DRUG

Intravenous glucose will be "dextrose 50%", amino acids (AA) will be "Primene®" and lipids (FAT) will be "Clinoleic®". Parenteral nutrition bags will be prepared by the hospital pharmacy according to the prescription of the attending neonatologist.

Personalized-Parenteral Nutrition (P-PN)

Eligibility Criteria

Age189 Days - 258 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight greater than 1250 grams,
  • Gestational age between 189 and 258 days,
  • In need of parenteral nutrition (PN),
  • Signed informed consent by at least one parent or legal guardian.

You may not qualify if:

  • Genetic, metabolic, or endocrine disorders diagnosed before/after enrolment
  • Ceftriaxone or Coumarin therapy before/after enrolment,
  • Calcium therapy before enrolment,
  • Cholestasis or hepatic insufficiency before enrolment,
  • Renal insufficiency before enrolment,
  • Hyponatremia before enrolment,
  • Hypertriglyceridemia before enrolment,
  • Hypersensitivity reaction to components of parenteral nutrition before/after enrolment,
  • Off-label use of drug therapy before/after enrolment,
  • Absent informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ospedali Riuniti Ancona

Ancona, 60123, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, Italy

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Related Publications (12)

  • Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.

    PMID: 16585322BACKGROUND

  • Evering VH, Andriessen P, Duijsters CE, Brogtrop J, Derijks LJ. The Effect of Individualized Versus Standardized Parenteral Nutrition on Body Weight in Very Preterm Infants. J Clin Med Res. 2017 Apr;9(4):339-344. doi: 10.14740/jocmr2893w. Epub 2017 Feb 21.

    PMID: 28270894BACKGROUND

  • 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: 20234142BACKGROUND

  • Dice JE, Burckart GJ, Woo JT, Helms RA. Standardized versus pharmacist-monitored individualized parenteral nutrition in low-birth-weight infants. Am J Hosp Pharm. 1981 Oct;38(10):1487-9.

    PMID: 6794364BACKGROUND

  • Yeung MY, Smyth JP, Maheshwari R, Shah S. Evaluation of standardized versus individualized total parenteral nutrition regime for neonates less than 33 weeks gestation. J Paediatr Child Health. 2003 Nov;39(8):613-7. doi: 10.1046/j.1440-1754.2003.00246.x.

    PMID: 14629529BACKGROUND

  • Mutchie KD, Smith KA, MacKay MW, Marsh C, Juluson D. Pharmacist monitoring of parenteral nutrition: clinical and cost effectiveness. Am J Hosp Pharm. 1979 Jun;36(6):785-7.

    PMID: 111548BACKGROUND

  • 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: 25655621BACKGROUND

  • Namgung R, Tsang RC, Sierra RI, Ho ML. Normal serum indices of bone collagen biosynthesis and degradation in small for gestational age infants. J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):224-8. doi: 10.1097/00005176-199610000-00004.

    PMID: 8890070BACKGROUND

  • Rossi L, Branca F, Cianfarani S. Collagen cross-links and early postnatal growth in newborns with intrauterine growth retardation. Metabolism. 2000 Nov;49(11):1467-72. doi: 10.1053/meta.2000.17670.

    PMID: 11092513BACKGROUND

  • Jones PJ, Winthrop AL, Schoeller DA, Swyer PR, Smith J, Filler RM, Heim T. Validation of doubly labeled water for assessing energy expenditure in infants. Pediatr Res. 1987 Mar;21(3):242-6. doi: 10.1203/00006450-198703000-00007.

    PMID: 3104873BACKGROUND

  • Schoeller DA, Ravussin E, Schutz Y, Acheson KJ, Baertschi P, Jequier E. Energy expenditure by doubly labeled water: validation in humans and proposed calculation. Am J Physiol. 1986 May;250(5 Pt 2):R823-30. doi: 10.1152/ajpregu.1986.250.5.R823.

    PMID: 3085521BACKGROUND

  • van Marken Lichtenbelt WD, Westerterp KR, Wouters L. Deuterium dilution as a method for determining total body water: effect of test protocol and sampling time. Br J Nutr. 1994 Oct;72(4):491-7. doi: 10.1079/bjn19940053.

    PMID: 7986782BACKGROUND

MeSH Terms

Conditions

Premature BirthHyperphagia

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Virgilio P Carnielli, MD, PhD

CONTACT

+39 071 596 2045v.carnielli@univpm.it

Alessio Correani, MSc, PHD

CONTACT

+39 071 596 2888alessio.correani@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients/Parents/Legal guardian will be masked. The statistician will be also masked when analyzing the data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 2, 2018

Study Start

July 4, 2021

Primary Completion

August 31, 2023

Study Completion

October 31, 2024

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)IT(2)