Diabetes Clinical Trial
— OPTIGROWOfficial title:
Body Composition, Metabolic Programming and Long Term Outcome of Growth Restricted Preterm Infants Under Different Nutritional Management A Prospective Randomized Controlled Multicenter Trial
NCT number | NCT02999945 |
Other study ID # | OPTIGROW |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2019 |
Est. completion date | January 2022 |
Verified date | March 2019 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this prospective randomized controlled multi center trial the investigators stratify "Very Low Birthweight " (VLBW)-infants with growth retardation in small for gestational age (SGA) or intrauterine growth restricted (IUGR) - infants and aim to investigate the impact of a nutritional management with enhanced nutrients from discharge up to the 52nd week of postconceptional age on growth, body composition, metabolic programming, metabolomics, microbiome and long term neurodevelopmental outcome. In this study, the investigators will evaluate the difference in metabolic profiles of SGA and IUGR preterm infants. The investigators will further longitudinally assess, how different nutritional interventions affect the altered pathways in the first year of life and identify, in combination with data available from metabolic markers, microbiome and breast milk analysis, potential pathways resulting in increased disease risk later in life.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2022 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 42 Weeks |
Eligibility |
Inclusion Criteria: - Preterm infants with a birth weight <1500g and birth weight <10th percentile. - Weight at term <10th percentile - Informed consent Exclusion Criteria: - Genetic or metabolic diseases with the primary effect on growth - Necrotizing enterocolitis - Intraventricular hemorrhage (IVH) >Grade II - Periventricular leukomalacia (PVL) Stage III - Genetic or metabolic disorders - Bronchopulmonary dysplasia |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna | Ludwig-Maximilians - University of Munich, Lund University, Medical University of Graz, Poznan University of Medical Sciences, University Hospital Tuebingen, University of Erlangen-Nürnberg Medical School, University of Milan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fat Free Mass | Fat free mass measured by body plethysmography | 3 months | |
Secondary | anthropometry-length | length in cm | 24 months | |
Secondary | anthropometry-weight | weight in grams | 24 months | |
Secondary | anthropometry-HC | head circumference in cm | 24 months | |
Secondary | anthropometry-z-score | z-scores | 24 months | |
Secondary | parameters of metabolic programming- IGF1 | IGF-1in ng/ml | 12 months | |
Secondary | parameters of metabolic programming-IGF3 | IGF-3 in ng/ml | 12 months | |
Secondary | parameters of metabolic programming-IGF-BP | IGF-BP in ng/ml | 12 months | |
Secondary | parameters of metabolic programming-Leptin | Leptin in ng/ml | 12 months | |
Secondary | parameters of metabolic programming-Adiponectin | Adiponectin in mcg/ml | 12 months | |
Secondary | neurodevelopmental outcome | Bayley scales | 24months | |
Secondary | metabolomics | Metabolomic analysis will determine around 200 metabolites covering polar lipids (SOFIA), acylcarnitines (CARN), non-esterified fatty acids (NEFA) and amino acids (AA). Data will be acquired according to retention time and mass transition on triple quadrupole mass spectrometer, controlled by Analyst. All metabolite concentrations are reported in µmol/L |
12 months | |
Secondary | stool microbiome | 24 months | ||
Secondary | macronutrients in breastmilk-fat | Fat will be analysed by modified Mojonnierether extraction (g/100ml) | 6 months | |
Secondary | macronutrients in breastmilk-Lactose | Lactose will be determined by Lactose analysis method: LC-MS/MS (g/100ml) | 6 months | |
Secondary | macronutrients in breastmilk-protein | Protein will be determined by elemental analysis (g/100ml) | 6 months |
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