Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Brain maturation assessed by magnetic resonance imaging (MRI)
研究概览
简要总结
The primary objective of this double-blind randomized study is to assess the effects of an early, enhanced supply of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA) on brain maturation, clinical outcomes and quality of growth in immature infants (gestational age <29 weeks) as compared to standard nutrient supply.
详细描述
This is a double-blind randomized study. 172 preterm infants with gestational age < 29 weeks will be enrolled. The intervention group will receive enteral supplementation with essential fatty acids, arachidonic acid (ARA) and docosahexaenoic acid (DHA). The control group will receive standard supplementation with medium-chain triglycerides (MCT-oil). The main hypothesis is that early, enhanced supply of ARA and DHA will improve brain growth and maturation, as compared to standard nutrient supply. Secondary hypotheses are that early, enhanced supply of ARA and DHA will improve quality of growth and cognitive development as well as reduce the frequency of inflammation-related neonatal comorbidities and long-term cardiovascular disease risk. Primary endpoint will be assessed by magnetic resonance imaging (MRI) of the brain at term equivalent age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extremely preterm infants born at Oslo University Hospital (OUH)
- •Gestational age (GA) < 29 weeks
- •Less than 48 hours of age at inclusion
- •Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to good clinical practice (GCP) and national/local regulations
排除标准
- •Major congenital malformations which will affect growth and development
- •Chromosomal abnormalities and other genetic diseases
- •Critical illness with short life expectancy as defined by the study physician
结局指标
主要结局
Brain maturation assessed by magnetic resonance imaging (MRI)
时间窗: 40 weeks postmenstrual age (PMA)
MRI with spectroscopy (MRS) and diffusion tensor imaging (DTI) will be used to examine myelinisation and quantification of anatomical structures as well as neuronal integrity and inflammation
次要结局
- Cerebral Background Activity evaluated by Electroencephalogram (EEG)(First week of life, 36 weeks PMA and 2 years corrected age (CA))
- Neurodevelopment assessed by standardized motor and cognitive tests(2 years corrected age (CA))
- Blood pressure(First week of life and at 36 weeks PMA and 2 years CA)
- Markers of inflammation(From birth until 36 weeks PMA)
- Micronutrient content in urine(From birth until 36 weeks PMA)
- Neonatal morbidities associated with inflammation(From birth til 36 weeks PMA)
- Lung function evaluated by tidal breathing measurements(36 weeks PMA, 3 months and 2 years CA)
- Gut microbiota(From birth until 36 weeks PMA)
- Markers of nutritional status in blood(From birth until 36 weeks PMA)
- Weight gain(Weight will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.)
- Growth(Length and HC will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.)
- Body composition(At 36 weeks PMA, 3 months and 2 years corrected age)
- Cardiovascular Health assessed by echocardiography(First week of life, 2nd week of life, at 36 weeks PMA and 2 years CA)
- Fatty acid (FA) profiles in blood(From birth until 36 weeks PMA)
- Markers of metabolic status(From birth until 36 weeks PMA)
- Evaluation of nutrient composition of expressed breast milk(From birth until 36 weeks PMA)
- Inflammatory markers in sputum(From birth until 36 weeks PMA)
研究者
Sissel Jennifer Moltu
MD, PhD, Principal Investigator
Oslo University Hospital