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Personalized vs Standardized PN for Preterm Infants >1250g

Primary Purpose

Infant,Premature, Parenteral Nutrition, Growth

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Standardized-parenteral nutrition (S-PN)
Personalized-parenteral nutrition (P-PN)
Sponsored by
Ospedali Riuniti Ancona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant,Premature focused on measuring Preterm, Infant, Parenteral Nutrition, Growth

Eligibility Criteria

189 Days - 258 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ospedali Riuniti AnconaRecruiting
  • Azienda Ospedaliera di PadovaRecruiting
  • Hospital Universitario La PazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Personalized-Parenteral Nutrition (P-PN)

Standardized-Parenteral Nutrition (S-PN)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MUSCLE ULTRASOUND (optional)
Ultrasound measurement of mid thigh and mid arm muscle thickness (cm).
ADIPOSE TISSUE ULTRASOUND (optional)
Ultrasound measurement of mid thigh and mid arm adipose tissue thickness (cm).
BONE ULTRASOUND (optional)
Metacarpus speed of sound (m/s) and metacarpus bone transmission time (ms).
WEIGHT
Weight measured by a digital infant scale (grams)
TOTAL BODY LENGTH
Total body length measured by a neonatal stadiometer (cm)
HEAD CIRCUMFERENCE
Head circumference measured by a flexible non-stretchable tape (cm)
GLUCIDE TOLERANCE
Blood glycemia (mg/dl).
AMINO ACID TOLERANCE
Plasma and urinary urea concentrations (mg/dl).
TRIGLYCERIDE CONCENTRATION
Plasma triglycerides (TG; mg/dl).
FATTY ACID CONCENTRATION (optional)
Plasma fatty acid concentration (FA; mg/dl).
DICARBOXYLIC AND HYDROXYL FATTY ACID CONCENTRATION (optional)
Urinary dicarboxylic acids (DCA; mmol/mol creatinine) and hydroxyl fatty acids (H-FA; mmol/mol creatinine).
ELECTROLYTE CONCENTRATION
Hemogasanalysis (Na+, mmol/l; K+, mmol/l; Ca2+, mg/dl; Cl-, mmol/l) and SBE (standard base excess, mmol/L)
HYPER AND HYPO-NATREMIA, -KALEMIA, -CHLOREMIA, -PHOSPHATEMIA, -CALCEMIA, AND -PARATHYROIDISM
Episodes of Hyper/Hypo Natremia, -KaIemia, -Chloremia, -Phosphatemia, -Calcemia, and -Parathyroidism (number).
METABOLIC ACIDOSIS
SBE < -7.5 mmol/L.
BONE MINERALIZATION-1: CALCIUM and PHOSPHORUS CONCENTRATIONS
Plasma and urinary calcium and phosphorus concentrations (mg/dl).
LIVER FUNCTION: ALP, AST, ALT AND GGT CONCENTRATIONS
Plasma alkaline phosphatase (ALP; UI/L), aspartate transaminase (AST; UI/L), alanine transaminase (ALT; UI/L), and gamma-glutamyl transpeptidase (GGT, UI/L).
BONE MINERALIZATION-2: PTH CONCENTRATIONS
Plasma parathormone concentrations (PTH; pg/ml).
BONE MINERALIZATION: PYD, PICP and ICTP CONCENTRATION (optional)
Urinary pyridinoline crosslinks of collagen (Pyd; nmol/L), serum carboxyterminal propeptide of type I procollagen (PICP; ng/mL) and serum cross-linked carboxyterminal telopeptide of type I collagen (ICTP; ng/mL)
BILIRUBIN CONCENTRATION
Plasma bilirubin (total and conjugated; mg/dl)
MORBIDITY - 1
The incidence of the main complication of prematurity (intraventricular hemorrhage of 3° and 4° grade; Periventricular leukomalacia; Patent ductus arteriosus; Retinopathy of Prematurity; Bronchopulmonary dysplasia and Sepsis).
MORBIDITY - 2
The incidence of Cholestasis and Renal and Hepatic Insufficiency.
MORTALITY BEFORE 42 WEEKS POST MENSTRUAL AGE
Death before 42 weeks post menstrual age (number).
MORTALITY DURING PARENTERAL NUTRITION
Death during PN (number).
ENTERAL NUTRITION INTAKES
Enteral nutrition intakes (ml/kg).
PARENTERAL NUTRITION INTAKES: AMINO ACIDS
Intravenous amino acid intakes (g/kg).
PARENTERAL NUTRITION INTAKES: LIPIDS
Intravenous lipid intakes (g/kg).
PARENTERAL NUTRITION INTAKES: GLUCOSE
Intravenous glucose intakes (g/kg).
PARENTERAL NUTRITION DURATION
PN duration (days).
MECHANICAL VENTILATION
Mechanical ventilation duration and oxygen therapy duration (days).
DRUG THERAPIES
Drug therapy duration (hours).
PHARMACOECONOMICS
Healthcare costs (euro).
METABOLIC COMPLICATIONS
Number of hypertriglyceridemic episodes (plasma triglycerides>265mg/dL), hyperglycemic and hypoglycemic episodes (blood glycaemia>175 mg/dL and <40 mg/dL, respectively) and elevated urea (blood urea>100 mg/dL).

Full Information

First Posted
September 26, 2018
Last Updated
March 22, 2023
Sponsor
Ospedali Riuniti Ancona
Collaborators
Azienda Ospedaliera di Padova, Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT03693287
Brief Title
Personalized vs Standardized PN for Preterm Infants >1250g
Official Title
Personalized Versus Standardized Parenteral Nutrition for Preterm Infants With a Birth Weight Greater Than 1250 Grams: a Multicenter Randomized Phase IV Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedali Riuniti Ancona
Collaborators
Azienda Ospedaliera di Padova, Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Parenteral nutrition (PN) is a crucial part of the clinical care of preterm infants. Traditionally different components of PN are prescribed individually considering requirements of an individual infant (P-PN). Recently, standardized PN formulations (S-PN) for preterm infants have been assessed and may have advantages including a better provision of nutrients, less prescription and administration errors, decreased risk of infection, and cost savings. The recent introduction of triple-chamber bags that provides total nutrient admixture for infants may have the additional advantage of decreased risk of contamination and ease of administration. The proposed intervention and hypothesis: The investigators propose a multi-centered Phase IV RCT to compare S-PN versus P-PN, that is the usual care for preterm infants with a birth weight >1250 grams requiring PN in the intensive care units involved in the study. The investigators hypothesize that weight gain during PN of preterm infants with a BW greater than 1250 grams who received S-PN is not statically inferior (< 2g/kg/d) to that of infants who received P-PN (Non-inferiority study). Study design: Preterm infants (gestational age between 189 and 258 days) with a BW greater than 1250 grams will be enrolled during hospitalization after the informed consent is drawn from parents or legal guardians. All infants will undergo a physical examination and the need of PN will be judged by the caring physician according to predefined criteria. Infants requiring PN will be divided into 3 clinical groups: Group A or EARLY HIGH-RISK INFANTS: these infants present in rather severe conditions at birth or soon after birth which make enteral nutrition (EN) impossible or non-desirable. In this group of infants, the investigators will include patients with Perinatal asphyxia, Perinatal shock (Cardiovascular or Septic), GI malformations, Severe Intra-uterine growth retardation (IUGR) with markedly abnormal prenatal doppler, and Miscellanea. These infants will have a central venous access soon after birth. Group B or INSUFFICIENT EN INTAKE: these Infants are in rather stable conditions after birth, however these infants may exhibit gastrointestinal (GI) intolerance of any origin. These patients will be randomized after 72 hours of life if the mean EN volume of the first 72-hrs of life will be less than 30 ml/kg/d or if EN intake on the third day will be less than 45 ml/kg/d. In this category, the investigators will include also those infants who will have their EN intake reduced below 30 ml/kg for 3 consecutive days (usually from day 3 through day 6) because of PDA treatment. These infants will have a central venous access inserted on the 3rd or 4th day of life if not already in place. Group C or LATE SICKNESS: these are the infants that experience a major sickness after a variable period of good gastrointestinal tolerance. In this group, the investigators will have infants with Necrotizing Enterocolitis (NEC), Severe Sepsis with abdominal distension and poor peristalsis, Septic Shock, or other severe unexpected conditions such as volvulus etc. These infants will also have a central venous access. Study infants within each clinical group will be divided into 2 blocks on the basis of their BW: 1250-1750 g (Block A) e >1750 g (Block B). Infants of each study group will be then randomly assigned to P-PN or S-PN (Intervention-arm). The study PN bags will be used until the study infants will not be able to tolerate 135 ml/kg/d enterally (range: 120-160 ml/kg/d according to the local practice) or until day 28 of PN (after the 28th day of PN, patients will receive PN according to the normal clinical practice).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant,Premature, Parenteral Nutrition, Growth
Keywords
Preterm, Infant, Parenteral Nutrition, Growth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients/Parents/Legal guardian will be masked. The statistician will be also masked when analyzing the data.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized-Parenteral Nutrition (P-PN)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standardized-Parenteral Nutrition (S-PN)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Standardized-parenteral nutrition (S-PN)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Personalized-parenteral nutrition (P-PN)
Intervention Description
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.
Primary Outcome Measure Information:
Title
WEIGHT CHANGE
Description
Daily weight change (g/kg/d) during parenteral nutrition (PN)
Time Frame
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 Outcome Measure Information:
Title
MUSCLE ULTRASOUND (optional)
Description
Ultrasound measurement of mid thigh and mid arm muscle thickness (cm).
Time Frame
At the start of PN, after 7, 14 and 28 days (+-1 d).
Title
ADIPOSE TISSUE ULTRASOUND (optional)
Description
Ultrasound measurement of mid thigh and mid arm adipose tissue thickness (cm).
Time Frame
At the start of PN, after 7, 14 and 28 days (+-1 d).
Title
BONE ULTRASOUND (optional)
Description
Metacarpus speed of sound (m/s) and metacarpus bone transmission time (ms).
Time Frame
At the start of PN, after 7, 14 and 28 days (+-1 d).
Title
WEIGHT
Description
Weight measured by a digital infant scale (grams)
Time Frame
Daily up to 42 weeks of post menstrual age or discharge if it comes first.
Title
TOTAL BODY LENGTH
Description
Total body length measured by a neonatal stadiometer (cm)
Time Frame
Weekly up to 42 weeks of post menstrual age or discharge if it comes first.
Title
HEAD CIRCUMFERENCE
Description
Head circumference measured by a flexible non-stretchable tape (cm)
Time Frame
Weekly up to 42 weeks of post menstrual age or discharge if it comes first.
Title
GLUCIDE TOLERANCE
Description
Blood glycemia (mg/dl).
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
AMINO ACID TOLERANCE
Description
Plasma and urinary urea concentrations (mg/dl).
Time Frame
At the start of PN, at PN day 7 (+-1 d) and 14 (+-1 d), and then every 2 weeks until the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
TRIGLYCERIDE CONCENTRATION
Description
Plasma triglycerides (TG; mg/dl).
Time Frame
At PN day 3 (+-1 d) and 7(+-1 d), and then every 7 days (+-1 d) until the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
FATTY ACID CONCENTRATION (optional)
Description
Plasma fatty acid concentration (FA; mg/dl).
Time Frame
At PN day 7 (+-1 d).
Title
DICARBOXYLIC AND HYDROXYL FATTY ACID CONCENTRATION (optional)
Description
Urinary dicarboxylic acids (DCA; mmol/mol creatinine) and hydroxyl fatty acids (H-FA; mmol/mol creatinine).
Time Frame
At PN day 7 (+-1 d).
Title
ELECTROLYTE CONCENTRATION
Description
Hemogasanalysis (Na+, mmol/l; K+, mmol/l; Ca2+, mg/dl; Cl-, mmol/l) and SBE (standard base excess, mmol/L)
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
HYPER AND HYPO-NATREMIA, -KALEMIA, -CHLOREMIA, -PHOSPHATEMIA, -CALCEMIA, AND -PARATHYROIDISM
Description
Episodes of Hyper/Hypo Natremia, -KaIemia, -Chloremia, -Phosphatemia, -Calcemia, and -Parathyroidism (number).
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
METABOLIC ACIDOSIS
Description
SBE < -7.5 mmol/L.
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
BONE MINERALIZATION-1: CALCIUM and PHOSPHORUS CONCENTRATIONS
Description
Plasma and urinary calcium and phosphorus concentrations (mg/dl).
Time Frame
At the start of PN and at PN day 7 (+-1 d). An additional measurement will be done at PN day 28 (+-1 d) in patients requiring long term PN.
Title
LIVER FUNCTION: ALP, AST, ALT AND GGT CONCENTRATIONS
Description
Plasma alkaline phosphatase (ALP; UI/L), aspartate transaminase (AST; UI/L), alanine transaminase (ALT; UI/L), and gamma-glutamyl transpeptidase (GGT, UI/L).
Time Frame
At the start of PN and at PN day 7 (+-1 d). An additional measurement will be done at PN day 28 (+-1 d) in patients requiring long term PN.
Title
BONE MINERALIZATION-2: PTH CONCENTRATIONS
Description
Plasma parathormone concentrations (PTH; pg/ml).
Time Frame
At the start of PN and at PN day 7 (+-1 d). An additional measurement will be done at PN day 28 (+-1 d) in patients requiring long term PN.
Title
BONE MINERALIZATION: PYD, PICP and ICTP CONCENTRATION (optional)
Description
Urinary pyridinoline crosslinks of collagen (Pyd; nmol/L), serum carboxyterminal propeptide of type I procollagen (PICP; ng/mL) and serum cross-linked carboxyterminal telopeptide of type I collagen (ICTP; ng/mL)
Time Frame
At the start of PN and at PN day 28 (+-1 d) (endpoint).
Title
BILIRUBIN CONCENTRATION
Description
Plasma bilirubin (total and conjugated; mg/dl)
Time Frame
At PN day 7 (+-1 d). An additional measurement will be performed at PN day 14 (+-1 d) in case of PN duration >14 days.
Title
MORBIDITY - 1
Description
The incidence of the main complication of prematurity (intraventricular hemorrhage of 3° and 4° grade; Periventricular leukomalacia; Patent ductus arteriosus; Retinopathy of Prematurity; Bronchopulmonary dysplasia and Sepsis).
Time Frame
Up to 42 weeks of post menstrual age or discharge if it comes first.
Title
MORBIDITY - 2
Description
The incidence of Cholestasis and Renal and Hepatic Insufficiency.
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
MORTALITY BEFORE 42 WEEKS POST MENSTRUAL AGE
Description
Death before 42 weeks post menstrual age (number).
Time Frame
At 42 weeks of post menstrual age or discharge if it comes first.
Title
MORTALITY DURING PARENTERAL NUTRITION
Description
Death during PN (number).
Time Frame
From the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
ENTERAL NUTRITION INTAKES
Description
Enteral nutrition intakes (ml/kg).
Time Frame
Daily from the start of PN to day 28 of life.
Title
PARENTERAL NUTRITION INTAKES: AMINO ACIDS
Description
Intravenous amino acid intakes (g/kg).
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
PARENTERAL NUTRITION INTAKES: LIPIDS
Description
Intravenous lipid intakes (g/kg).
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
PARENTERAL NUTRITION INTAKES: GLUCOSE
Description
Intravenous glucose intakes (g/kg).
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
PARENTERAL NUTRITION DURATION
Description
PN duration (days).
Time Frame
Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days).
Title
MECHANICAL VENTILATION
Description
Mechanical ventilation duration and oxygen therapy duration (days).
Time Frame
Up to 42 weeks of post menstrual age or discharge if it comes first.
Title
DRUG THERAPIES
Description
Drug therapy duration (hours).
Time Frame
Up to 42 weeks of post menstrual age or discharge if it comes first.
Title
PHARMACOECONOMICS
Description
Healthcare costs (euro).
Time Frame
Up to 42 weeks of post menstrual age or discharge if it comes first.
Title
METABOLIC COMPLICATIONS
Description
Number of hypertriglyceridemic episodes (plasma triglycerides>265mg/dL), hyperglycemic and hypoglycemic episodes (blood glycaemia>175 mg/dL and <40 mg/dL, respectively) and elevated urea (blood urea>100 mg/dL).
Time Frame
Up to 42 weeks of post menstrual age or discharge if it comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
189 Days
Maximum Age & Unit of Time
258 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virgilio P Carnielli, MD, PhD
Phone
+39 071 596 2045
Email
v.carnielli@univpm.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessio Correani, MSc, PHD
Phone
+39 071 596 2888
Email
alessio.correani@gmail.com
Facility Information:
Facility Name
Ospedali Riuniti Ancona
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virgilio Carnielli, MD, PhD
Phone
+390715962045
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanna Verlato, MD, PhD
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Pipaon, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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.
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Personalized vs Standardized PN for Preterm Infants >1250g

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