A Randomised Intervention Single Center Study to Determine the Role of Fatty Acids in Serum in Preventing Retinopathy of Prematurity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Retinopathy of Prematurity
研究概览
简要总结
Most fatty acids, important for development and especially the Omega-3 fatty acids for the brain development are transferred in the third trimester with means that in the premature infant this transport via the placenta is interrupted and the infant is dependent on the concentrations in breast milk which vary depending on the mother's diet and her stores. It has even been suggested that low Omega-3 would be a cause of premature delivery. Many countries have much higher levels of Omega-3 fatty acids in breast milk than found in Sweden and breast milk substitutions are generally now supplemented with the Long Chained Poly Unsaturated Fatty Acids (LCPUFA). Therefore the supplementation to be given can not be seen to give any risks for the infant. On the contrary, several studies have shown that mother who eat equal to or less than twice fish a week during pregnancy give birth to infants with impaired development.
Low Omega-3 levels in premature infants between gestational ages of 23 and 40 weeks can be one reason for Retinopathy of Prematurity (ROP) development. Restoration of Omega-3, Dokosahexaenacid (DHA) and Eikosapentaenacid (EPA) to normal in utero levels may prevent ROP by allowing normal vessel growth and survival. An increase of Omega-3 levels bringing levels to within physiological range may prevent development of ROP.
详细描述
The study is a Randomised Intervention, Single-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 randomised intervention study of 45+45 infants without major malformations born with a gestational age less than 28 weeks + 0 days will be performed.
Randomization of the patients to either:
- Conventional fatty acid supplementation regime with Clinoleic (with Vitalipid infant and Soluvit supplementation) to the preterm infant
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
- 23 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent from parents/guardians;
- •Subject must be below 28 weeks of gestation
排除标准
- •Detectable clinical gross malformation;
- •Known or suspected chromosomal abnormality, genetic disorder, or syn-drome, 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.
- •Bleeding disorder.
研究组 & 干预措施
Clinoleic
Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity
干预措施: Clinoleic (Drug)
SMOFlipid
Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity
干预措施: SMOFlipid (Drug)
结局指标
主要结局
Retinopathy of Prematurity
时间窗: When the retina is fully vascularised,i.e. at approximately 40 postmenstrual weeks.
We intend to analyze the content of Fatty Acids and correlate to Retinopathy of Prematurity development and interventional treatment. Analyze of phospholipids can be done on small amounts of blood, is relatively insensitive to short term fluctuations in intake and mirror the composition of many membranes in the body. The analyses will be made using gas-liquid chromatography. The method has a coefficient of variability of 1-3% for the Fatty Acids concerned.
次要结局
- Brain Growth(At 40 postmenstrual weeks and at 2.5 and 6 years.)
- Length in cm(At 40 postmenstrual weeks and at 2.5 and 6 years.)
- Weight in gram(At 40 postmenstrual weeks and at 2.5 and 6 years.)
- Head circumference in cm(At 40 postmenstrual weeks and at 2.5 and 6 years.)
研究者
Carola Pfeiffer-Mosesson
Research Nurse
Queen Silvia Children's Hospital, Gothenburg, Sweden