Neuroimaging Ancillary Study of the IV Iron RAPIDIRON Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Fetal hippocampal volume
研究概览
简要总结
As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.
详细描述
The hypothesis of this study is as follows:
- Reduced iron availability through fetal development impacts fundamental early neurodevelopmental processes, including neurogenesis of the hippocampus, amygdala, and other 'core' deep brain basal ganglia regions (e.g., globus pallidus); and myelination of the brain's white matter connecting these deep brain structures and higher-order cortical regions involved in motor, memory, and executive functioning.
The specific aims of this Neuroimaging Ancillary Study are:
- To determine impact of the IV iron intervention compared to oral iron on specific markers of brain development; and
- As a secondary analysis, to explore whether infant sex acts as a moderator of treatment on these specific brain development markers.
This study will recruit pregnant mothers currently participating in the parent RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in this Neuroimaging Ancillary Study. Participation in this Ancillary Study will involve assessments at 32-35 weeks fetal gestational age, birth, 4 months, 12 months, and 24 months post-delivery. This will involve a fetal MRI and three post-birth MRIs conducted with the offspring to collect the main neuroimaging measures. In addition, we will collect various secondary offspring and maternal measures including child auditory brain response; maternal depression, anxiety, perceived stress, and empowerment; hair cortisol; and breastmilk micronutrient analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For the maternal participant in the parent RAPIDIRON Trial - a pregnancy that has not gone beyond the period for obtaining a fetal MRI (by scanning the mother at 32-35 weeks fetal gestational age)
- •An indication of the pregnant woman's intent to deliver in the study area and to reside there so as to be available not only to complete RAPIDIRON participation but also to allow her and her offspring to participate in ancillary study visits;
- •Informed consent of the pregnant RAPIDIRON participant for her participation and that of her offspring in this ancillary trial; and
- •Concurrent participation in the RAPIDIRON-KIDS follow-up study (NCT05504863).
排除标准
- •If a fetal brain anomaly is found when the maternal participant undergoes an MRI at 32-35 weeks fetal gestational age, the dyad would be excluded from the ancillary study;
- •If any of the following occur, this would result in dyad ineligibility for participation or continued participation in this ancillary study: maternal blood transfusion after enrollment, a pregnancy ending in stillbirth, neonatal death, diagnosis in the offspring of moderate to severe hypoxic-ischemic encephalopathy (or HIE), and/or blood transfusion to the offspring.
研究组 & 干预措施
RAPIDIRON IV iron intervention arm 1
Maternal participants in this arm were given a single dose of an IV iron formulation - ferric carboxymaltose - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age.
干预措施: Ferric carboxymaltose (Drug)
RAPIDIRON IV iron intervention arm 2
Maternal participants in this arm were given a single dose of an IV iron formulation - iron isomaltoside - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age.
干预措施: Iron isomaltoside (Drug)
RAPIDIRON active comparator arm
Maternal participants in this arm of the RAPIDIRON Trial were given ferrous sulfate tablets with 60mg elemental iron each and instructed to take two per day (one in the morning and one at night) throughout their pregnancy.
干预措施: Ferric Sulfate (Drug)
结局指标
主要结局
Fetal hippocampal volume
时间窗: 32-35 weeks fetal gestational age
Fetal hippocampus volume, measured via fetal MRI
Fetal diffusion parameters: fractional anisotropy (FA)
时间窗: 32-35 weeks fetal gestational age
Fetal white matter microstructure will be measured via FA at the posterior limb of internal capsule using fetal MRI
Fetal diffusion parameters: mean diffusivity
时间窗: 32-35 weeks fetal gestational age
Fetal white matter microstructure will be measured via MD at the posterior limb of internal capsule using fetal MRI
次要结局
- Child white matter volume(4 - 24 months of age)
- Child functional connectivity(4 - 24 months of age)
- Fetal white matter microstructure measures(32-35 weeks fetal gestational age)
- Child cerebral metabolism(4 - 24 months of age)
- Child white matter microstructure(4 - 24 months of age)
- Child white matter connectivity(4 - 24 months of age)
- Fetal sub-cortical gray matter structures(32-35 weeks fetal gestational age)
- Child hippocampal volume(4 - 24 months of age)