Growth Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | October 31, 2024 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 189 Days to 258 Days |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedali Riuniti Ancona | Ancona | |
Italy | Azienda Ospedaliera di Padova | Padova | |
Spain | Hospital Universitario La Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Ospedali Riuniti Ancona | Azienda Ospedaliera di Padova, Hospital Universitario La Paz |
Italy, Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View 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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | MUSCLE ULTRASOUND (optional) | Ultrasound measurement of mid thigh and mid arm muscle thickness (cm). | At the start of PN, after 7, 14 and 28 days (+-1 d). | |
Secondary | ADIPOSE TISSUE ULTRASOUND (optional) | Ultrasound measurement of mid thigh and mid arm adipose tissue thickness (cm). | At the start of PN, after 7, 14 and 28 days (+-1 d). | |
Secondary | BONE ULTRASOUND (optional) | Metacarpus speed of sound (m/s) and metacarpus bone transmission time (ms). | At the start of PN, after 7, 14 and 28 days (+-1 d). | |
Secondary | WEIGHT | Weight measured by a digital infant scale (grams) | Daily up to 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | TOTAL BODY LENGTH | Total body length measured by a neonatal stadiometer (cm) | Weekly up to 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | HEAD CIRCUMFERENCE | Head circumference measured by a flexible non-stretchable tape (cm) | Weekly up to 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | GLUCIDE TOLERANCE | Blood glycemia (mg/dl). | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | AMINO ACID TOLERANCE | Plasma and urinary urea concentrations (mg/dl). | 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). | |
Secondary | TRIGLYCERIDE CONCENTRATION | Plasma triglycerides (TG; mg/dl). | 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). | |
Secondary | FATTY ACID CONCENTRATION (optional) | Plasma fatty acid concentration (FA; mg/dl). | At PN day 7 (+-1 d). | |
Secondary | DICARBOXYLIC AND HYDROXYL FATTY ACID CONCENTRATION (optional) | Urinary dicarboxylic acids (DCA; mmol/mol creatinine) and hydroxyl fatty acids (H-FA; mmol/mol creatinine). | At PN day 7 (+-1 d). | |
Secondary | ELECTROLYTE CONCENTRATION | Hemogasanalysis (Na+, mmol/l; K+, mmol/l; Ca2+, mg/dl; Cl-, mmol/l) and SBE (standard base excess, mmol/L) | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | HYPER AND HYPO-NATREMIA, -KALEMIA, -CHLOREMIA, -PHOSPHATEMIA, -CALCEMIA, AND -PARATHYROIDISM | Episodes of Hyper/Hypo Natremia, -KaIemia, -Chloremia, -Phosphatemia, -Calcemia, and -Parathyroidism (number). | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | METABOLIC ACIDOSIS | SBE < -7.5 mmol/L. | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | BONE MINERALIZATION-1: CALCIUM and PHOSPHORUS CONCENTRATIONS | Plasma and urinary calcium and phosphorus concentrations (mg/dl). | 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. | |
Secondary | 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). | 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. | |
Secondary | BONE MINERALIZATION-2: PTH CONCENTRATIONS | Plasma parathormone concentrations (PTH; pg/ml). | 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. | |
Secondary | 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) | At the start of PN and at PN day 28 (+-1 d) (endpoint). | |
Secondary | BILIRUBIN CONCENTRATION | Plasma bilirubin (total and conjugated; mg/dl) | 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. | |
Secondary | 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). | Up to 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | MORBIDITY - 2 | The incidence of Cholestasis and Renal and Hepatic Insufficiency. | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | MORTALITY BEFORE 42 WEEKS POST MENSTRUAL AGE | Death before 42 weeks post menstrual age (number). | At 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | MORTALITY DURING PARENTERAL NUTRITION | Death during PN (number). | From the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | ENTERAL NUTRITION INTAKES | Enteral nutrition intakes (ml/kg). | Daily from the start of PN to day 28 of life. | |
Secondary | PARENTERAL NUTRITION INTAKES: AMINO ACIDS | Intravenous amino acid intakes (g/kg). | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | PARENTERAL NUTRITION INTAKES: LIPIDS | Intravenous lipid intakes (g/kg). | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | PARENTERAL NUTRITION INTAKES: GLUCOSE | Intravenous glucose intakes (g/kg). | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | PARENTERAL NUTRITION DURATION | PN duration (days). | Daily from the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). | |
Secondary | MECHANICAL VENTILATION | Mechanical ventilation duration and oxygen therapy duration (days). | Up to 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | DRUG THERAPIES | Drug therapy duration (hours). | Up to 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | PHARMACOECONOMICS | Healthcare costs (euro). | Up to 42 weeks of post menstrual age or discharge if it comes first. | |
Secondary | 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). | Up to 42 weeks of post menstrual age or discharge if it comes first. |
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