Effect of Iron Supplementation During Pregnancy on Neurodevelopmental Status of Babies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 538
- 试验地点
- 3
- 主要终点
- Cognitive Domain of Bayley Scales of Infant Development (BSID)
研究概览
简要总结
As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.
详细描述
The RAPIDIRON-KIDS Study has two primary hypotheses:
- Infants born to RAPIDIRON Trial maternal participants from the intravenous (IV) iron arms will have higher hemoglobin and ferritin levels at birth (determined by cord blood) and at 4 months of age compared to infants born to mothers in the oral arm; and
- Offspring born to RAPIDIRON Trial participants who received IV iron treatment will have higher developmental quotients (DQs) on the cognitive domain of the Bayley Scales of Infant Development (BSID) at 2 years of age compared to offspring born to RAPIDIRON Trial participants given oral iron treatment.
The specific aims of this study are as follows:
- To provide evidence that a single-dose of IV iron (either ferric carboxymaltose or iron isomaltoside, also known as ferric derisomaltose) given to pregnant women in the second trimester during the RAPIDIRON Trial will prove more effective for prevention of neonatal and postnatal iron deficiency in the offspring than the oral iron given to pregnant women per the parent trial protocol
- To assess if the offspring of women in the parent trial IV iron arms have better neurodevelopmental outcomes compared to the offspring of women treated with oral iron; and
- To determine longer-term hematologic effects in previously randomized mothers by obtaining ongoing hematologic indices, documented history of transfusion and hospitalization, and quality of life based on the use of a validated instrument.
This study will recruit pregnant mothers currently participating in the RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in the RAPIDIRON-KIDS Study. Participation in RAPIDIRON-KIDS will involve assessments at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months of age. In addition to iron status, anthropometry, and questionnaires relating to child feeding and maternal quality of life, the following neurobehavioral tests will be utilized to assess the offspring at various timepoints: Preferential Looking Test, Ages & Stages Questionnaire 3, Bayley Scales of Infant Development, Behavioral Rating Scale, India Scale for Assessment of Autism, and the Child Behavior Checklist for Ages 1.5-5.
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
- •Informed consent of the RAPIDIRON Trial participant for their study inclusion and that of their offspring for the RAPIDIRON-KIDS Study
- •Expressed intent of the RAPIDIRON Trial participant to remain in the designated Karnataka research are for delivery and during the follow-up period for the RAPIDIRON-KIDS Study to enable participation in study visits
- •For the offspring - live-born singleton infants of Karnataka maternal participants randomized and treated in the RAPIDIRON Trial, if consent is provided by the mother
排除标准
- •Unwillingness of maternal participant to provide RAPIDIRON-KIDS Study consent for herself and her 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
Cognitive Domain of Bayley Scales of Infant Development (BSID)
时间窗: 24 months of age
Developmental quotient (DQ) on the cognitive domain of the Bayley Scales of Infant Development (BSID), conducted at 24 months of age. The Cognitive Domain of the BSID-IV contains 81 items, each item with a minimum score of 0 and a maximum score of 2. A lower score is a bad outcome and a higher score is a good outcome.
Offspring hemoglobin
时间窗: 4 months of age
Offspring hemoglobin concentration in g/dL
Offspring ferritin
时间窗: 4 months of age
Offspring serum ferritin concentration in ng/mL
次要结局
- Offspring hemoglobin(12 months of age)
- Infant and Young Child Feeding Practices(Birth, 6 weeks, 4, 12, and 24 months of age)
- Maternal hemoglobin concentration(4, 12, and 24 month visits)
- Maternal well-being/quality of life(4 and 12 month visits)
- Bayley Scales of Infant Development (BSID)(36 months of age)
- Ages & Stages Questionnaire 3(12 months of age)
- Child Behavior Checklist for Ages 1.5-5(24 and 36 months of age)
- India Scale of Assessment for Autism(36 months of age)
- Offspring weight(4, 12, 24, and 36 months of age)
- Offspring ferritin(12 months of age)
- Preferential Looking Time(4 and 12 months of age)
- Motor and language domains of the Bayley Scales of Infant Development (BSID)(24 months of age)
- Behavior Rating Scale(24 months of age)
- Offspring height(6 weeks, 4, 12, 24, and 36 months of age)
- Offspring head circumference(Birth, 4, 12, 24, and 36 months of age)
- Maternal ferritin(4, 12, and 24 month visits)