Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 304
- 试验地点
- 8
- 主要终点
- Bayley III scale at 24 months of age
研究概览
简要总结
Singleton pregnancies being diagnosed of fetal growth restriction from 24 to 32.6 weeks of gestation will be randomized to two equally sized groups: maternal oral supplementation with Lactoferrin and DHA (Docosahexaenoic acid) or placebo.
详细描述
Randomized controlled trial among pregnant women that have been diagnosed of fetal growth restriction. These women will be randomized in order to evaluate the impact of maternal supplementation with Lactoferrin and DHA on the neurodevelopment outcome of their babies.
Main hypothesis: a prenatal intervention based on maternal supplementation with Lactoferrin and DHA improves neurodevelopment in fetal growth restriction.
Secondary hypothesis are that a prenatal intervention based on maternal supplementation with Lactoferrin and DHA in fetal growth restriction improves fetal growth and improves perinatal morbidity and mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancies
- •Non-malformed fetus
- •Pregnancies with fetal growth restriction
- •24-32.6 weeks of gestation
排除标准
- •Chromosomal or structural abnormalities diagnosed during pregnancy or in the neonatal period
- •Critical Doppler study suggesting the need for delivery within the next 14 days at the time of diagnosis: reverse end-diastolic velocity in the umbilical artery or ductus venosus pulsatility >95th centile
- •Maternal mental or psychiatric disorders
- •Maternal allergy to cow's milk protein
研究组 & 干预措施
Maternal supplementation with Lactoferrin and DHA
The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
干预措施: Lactoferrin and DHA (Dietary Supplement)
Placebo
Product with the same physical appearance and taste as the main intervention but without therapeutic effect
干预措施: Placebo (Other)
结局指标
主要结局
Bayley III scale at 24 months of age
时间窗: 24 months of corrected postnatal age
Bayley III scale is and individually administered instrument that assesses infant development across five domains, including cognitive, language and motor competencies. Parent reported questionnaires are incorporated to assess social-emotional and adaptative behaviors.
次要结局
- Neonatal weight(Delivery)
- Fetal brain volume(34 weeks of gestation)
- Corpus callosum area(Enrolment, 32 and 36 weeks of gestation)
- Perinatal morbidity and mortality(Perinatal period: period ranging from 32 weeks of gestation (154 days) to the end of the first 4 weeks of neonatal life (28 days))
- Cortical development(34 weeks of gestation)
- Postnatal neurodevelopmental assessment(Between 4 and 24 months of corrected postnatal age)
- Occurrence of adverse effects(Through intervention (supplementation) completion, from enrolment to delivery)
研究者
Elisenda Eixarch Roca
Coordinator of Fetal Neurology Unit
Institut d'Investigacions Biomèdiques August Pi i Sunyer