| - candidate number | 2445 |
| - NTR Number | NTR888 |
| - ISRCTN | ISRCTN45943101 |
| - Date ISRCTN created | 26-feb-2007 |
| - date ISRCTN requested | 21-feb-2007 |
| - Date Registered NTR | 5-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | Insulin sensitivity in preterm AGA and SGA infants. |
| - Scientific Title | Insulin sensitivity in preterm AGA and SGA infants. |
| - ACRONYM | N/A |
| - hypothesis | Insulin sensitivity is already reduced at birth in preterm SGA infants, compared to preterm AGA infants. |
| - Healt Condition(s) or Problem(s) studied | Insulin sensitivy, Prematurity, Dysmaturity |
| - Inclusion criteria | 1. Premature infants 28-32 weeks gestational age; 2. Presence of a (central) venous and arterial catheter for clinical reasons; 3. For preterm SGA infants: growth retardation caused by placental insufficiency, assessed by maternal history (pregnancy induced hypertension, preeclampsia), and confirmed by Doppler flow measurements of the umbilical arteries (Pulsatility index, PI, >+2 SD for gestational age, measured on two occasions) |
| - Exclusion criteria | 1. For preterm SGA infants: growth retardation based on other causes (e.g. congenital infections, congenital malformations); 2. Major congenital malformations; 3. Severe perinatal asphyxia defined as 5 minute Apgar score <7; 4. Severe disturbances of glucose metabolism (glucose intake <4 or >8 mg.kg-1.min-1, or need for insulin therapy to maintain the glucose concentration between 2.6 and 8 mmol/l); 5. Severe respiratory distress. Mild ventilatory support is allowed: a. nCPAP with maximum FiO2 of 0.40, maximum PEEP 6 cm H2O; b. SIMV with maximum inspiratory peak pressure of 18 cm H2O and maximum FiO2 of 0.40; c. HFOV with maximum continuous distending pressure of 12 cm H2O and maximum FiO2 of 0.30; 6. Need of vasopressor support for hypotension; 7. Treatment with systemic corticosteroids; 8. Clinical or laboratory evidence of sepsis: lethargy or irritability, hypo- or hyperthermia, temperature instability, tachypnea, apnea, bradycardia, hypotension, gastric retention, abdominal distension, pallor, elevated CRP-level, leukocytosis or leukocytopenia and increased number of band neutrophils; 9. Low haemoglobin level at the study days with need for a blood transfusion; 10. Positive family history for type 2 diabetes in first degree relatives; 11. No informed consent from parents or legal guardians. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | no |
| - group | [default] |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-apr-2007 |
| - planned closingdate | 1-apr-2008 |
| - Target number of participants | 16 |
| - Interventions | Not applicable. Observational study |
| - Primary outcome | Rate of appearance and disappearance of glucose during insulin infusion |
| - Secondary outcome | 1. Rate of gluconeogenesis and glycogenolysis; 2. Plasma FFA concentrations; 3. Plasma concentrations of insulin, cortisol and adiponectin. |
| - Timepoints | |
| - Trial web site | Not applicalble |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Prof. Dr. H.P. Sauerwein |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. H.P. Sauerwein |
| - Sponsor/Initiator | Academic Medical Center (AMC), Emma Children's Hospital, Department of Neonatology, Academic Medical Center (AMC), Department of Endocrinology and Metabolism |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Department of Endocrinology and Metabolism |
| - Publications | N/A |
| - Brief summary | Low birth weight neonates and premature neonates generally have a decreased insulin sensitivity in childhood. In pathogenesis of decreased insulin sensitivity intra uterine and postnatal factors may play an important role. No data are known if there are yet any differences at birth in insulin sensitivity in premature appropriate for gestational age (AGA)infants end premature small for gestational age (SGA) infants, suggesting influence of intra uterine factors. Researchquestion is: Is insulin sensitivity in premature SGA infants decreased in relation to insulin sensitivity in premature AGA infants at day 2? |
| - Main changes (audit trail) | |
| - RECORD | 5-feb-2007 - 13-nov-2008 |
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