ISRCTN45943101已完成未知
Insulin sensitivity in preterm appropriate-for-gestational-age and small-for-gestational-age infants
Diabetes Fonds Nederland (The Netherlands)0 个研究点目标入组 16 人开始时间: 2007年2月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Premature infants 28 to 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] more than +2 Standard Deviation [SD] for gestational age, measured on two occasions)
排除标准
- •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 five minute Apgar score less than seven
- •4. Severe disturbances of glucose metabolism (glucose intake less than 4 or more than 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. nasal Continuous Positive Airway Pressure (nCPAP) with maximum Fraction of Inspired Oxygen (FiO2) of 0.40, maximum Positive End Expiratory Pressure (PEEP) 6 cm Water (H2O)
- •b. Synchronised Intermittent Mandatory Ventilation (SIMV) with maximum inspiratory peak pressure of 18 cm H2O and maximum FiO2 of 0.40
- •c. High Frequency Oscillatory Ventilation (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 C- Reactive Protein (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 two diabetes in first degree relatives
- •11. No informed consent from parents or legal guardians
研究者
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