NL-OMON28578招募中不适用

Insulin sensitivity in preterm AGA and SGA infants.

Drs I.A. ZonnenbergAcademisch Medisch CentrumNeonatologie, H3-213Meibergdreef 91105 AZ Amsterdam0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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)

•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.

发起方

Drs I.A. ZonnenbergAcademisch Medisch CentrumNeonatologie, H3-213Meibergdreef 91105 AZ Amsterdam