A Randomized Intervention, Multi-Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity (MDM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- Investigate whether enteral administration of AA and DHA in addition to commonly used regimes with parenteral olive based lipid emulsion (Clinoleic) compared to Clinoleic alone prevents the sight threatening disease Retinopathy of Prematurity (ROP).
研究概览
简要总结
The study is a Randomized Intervention, Multi-Center Study to Determine the Role of Fatty Acids in Serum and Breast Milk in preventing Retinopathy of Prematurity Subjects who meet all inclusion and none of the exclusion criteria will be enrolled into the study. Upon entry into the study, subjects will be randomized and given a unique subject number.
A randomized intervention study of 105+105 (number based on power analysis regarding up to date ROP frequency, see 5.1 and 11.1) infants without major malformations born with a gestational age less than 28 weeks + 0 days will be performed.
详细描述
Every year around 10-12 % of all infants in Europe and the USA are born prematurely which results in 950000 preterm infants per year (500000 in Europe and 450000 in USA). Direct complications of preterm birth account for one million deaths each year worldwide, and preterm birth is a risk factor in over 50% of all neonatal deaths. In addition, preterm birth can result in a range of long-term complications in survivors, with the frequency and severity of adverse outcomes rising with decreasing gestational age and decreasing quality of care. The annual costs, beside patient suffering and parental emotional stress, of preterm care in USA amounts to 26,2 billion United States dollar in terms of immediate neonatal intensive care, subsequent long-term complex health care needs, as well as lost economic productivity.
Possible problems that may occur after a preterm birth are:
Organ disorders (intestine, heart, lung - BPD and asthma), ears (hearing problems), eyes (ROP and visual problems).
Feeding problems and failure to thrive, Poor general growth,Physical disabilities such as cerebral palsy,Cognitive impairment,Learning disability or behavioral problems such as attention deficit (ADD) or autism spectrum disorders. Of infants born extremely prematurely, i.e. at less than 28 weeks gestation or with extremely low birth weight (<1000 g), 20 - 30% may show developmental disorders requiring treatment (3, 4). Impaired cognitive development and abnormal behavior may cause problems at school; in some countries the percentage of learning difficulties in the preterm population is as high as 25%.
Much has been done to improve neonatal care e.g. target levels for oxygen saturation has been an issue for extensive discussions and clinical trials. In fact, the optimal oxygen saturation level for preterm infants has been called "a moving target", fluctuating almost as much as our patients oxygen saturation levels. Reaching a consensus on what these levels should be is still a work in progress. Nutrient delivery is another important and central area of neonatal care which is closely associated with morbidity outcome, and is in need of evidence-based guidelines. The project therefore aims to improve nutrient delivery to prevent or reduce the development of preterm disabilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all the following inclusion criteria to be permitted into this study:
- •Signed informed consent from parents/guardians;
- •Subject must be born before 28 weeks of gestation
排除标准
- •Subjects presenting with any of the following will be excluded from the study:
- •Detectable clinical gross malformation;
- •Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the investigator's opinion;
- •Clinically significant neuropathy, nephropathy, retinopathy, or other micro or macrovascular disease requiring treatment, according to the investigator's opinion
- •Any other condition or therapy that, in the investigator's opinion, may pose a risk to the subject or interfere with the subject's ability to be compliant with this protocol or interfere with interpretation of results.
结局指标
主要结局
Investigate whether enteral administration of AA and DHA in addition to commonly used regimes with parenteral olive based lipid emulsion (Clinoleic) compared to Clinoleic alone prevents the sight threatening disease Retinopathy of Prematurity (ROP).
时间窗: When the retina is fully vascularised, i.e approximately 40 postmenstrual weeks.
Fatty Acids content (AA/DHA) in children with Retinopathy of Prematurity, change from baseline to 40 weeks postmenstrual weeks. Analyses of phospholipids witch can be done on small amount of blood, is relatively intensitive to short term fluctuations in intake and mirror the composition of many membranes in the body. The analyses will be made by using gas-liquid-chromatography. The method has a coefficient of variability of 1-3% for the Fatty Acids concerned.
次要结局
- Outcome in head circumference in centimeters.(at day 0, 7, 14, 21 and thereafter every week up to 40 weeks postmenstrual age)
- Outcome in weight in kilograms.(at day 0, 7, 14, 21 and thereafter every week up to 40 weeks postmenstrual age)
- Outcome in height in centimeters.(at day 0, 7, 14, 21 and thereafter every week up to 40 weeks postmenstrual age)
- Postnatal serum fatty acid composition in preterm infants with and without AA:DHA supplementation.(at 0h, 72h, day7, day 14, every other week until postmenstrual age 29 week and thereafter 30, 32, 34, 36 and 40 weeks postmenstrual age)
- Postnatal brain development, as assessed by Magnetic Resonance Imaging (MRI)(at 40 weeks postmenstrual age and at 2.0 y corrected age and 5.5 y uncorrected age.)
- Outcome in p-glucose(at 0h, 72h, day7, day 14, every other week until postmenstrual age 29 week and thereafter at 30, 32, 34, 36 and 40 weeks postmenstrual age.)
- Outcome of neonatal morbidities.(Reported as adverse event from birth to 40 weeks postmenstrual age.)