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| Name | Class |
|---|---|
| Jawaharlal Nehru Medical College | OTHER |
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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.
The hypothesis of this study is as follows:
The specific aims of this Neuroimaging Ancillary Study are:
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.
Please see the protocol for additional details.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal hippocampal volume | Fetal hippocampus volume, measured via fetal MRI | 32-35 weeks fetal gestational age |
| Fetal diffusion parameters: fractional anisotropy (FA) | Fetal white matter microstructure will be measured via FA at the posterior limb of internal capsule using fetal MRI | 32-35 weeks fetal gestational age |
| Fetal diffusion parameters: mean diffusivity | Fetal white matter microstructure will be measured via MD at the posterior limb of internal capsule using fetal MRI | 32-35 weeks fetal gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal sub-cortical gray matter structures | Fetal sub-cortical gray matter structures in the brain using fetal MRI | 32-35 weeks fetal gestational age |
| Fetal white matter microstructure measures |
| Measure | Description | Time Frame |
|---|---|---|
| Child auditory brain response (ABR) results | Results on auditory brain response test | Birth - 4 months of age |
| Hair cortisol results | Results from hair cortisol testing |
Inclusion Criteria:
Exclusion Criteria:
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For this ancillary study, only infants of randomized RAPIDIRON Trial (NCT05358509) participants recruited in Karnataka State will be eligible for participation.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Derman, MD, MPH | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jawaharlal Nehru Medical College | Belagavi | Karnataka | India |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| C557707 | iron isomaltoside 1000 |
| C000718030 | ferric derisomaltose |
| C024823 | ferric sulfate |
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| Iron isomaltoside | Drug | As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy. |
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| Ferric Sulfate | Drug | As part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron. |
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Additional fetal white matter microstructure measures using fetal MRI, including qualitative T2 MRI measures and NODDI metrics
| 32-35 weeks fetal gestational age |
| Child hippocampal volume | Child hippocampal volume, measured via MRI | 4 - 24 months of age |
| Child white matter volume | Child white matter volume, measured via MRI | 4 - 24 months of age |
| Child white matter microstructure | Child white matter microstructure, including myelination, fiber coherence, and architecture, measured via MRI | 4 - 24 months of age |
| Child white matter connectivity | Child white matter connectivity, measured via MRI | 4 - 24 months of age |
| Child functional connectivity | Child functional connectivity, measured via MRI | 4 - 24 months of age |
| Child cerebral metabolism | Child cerebral metabolism, including perfusion and spectroscopy, measured via MRI | 4 - 24 months of age |
| Birth |
| Maternal depression | Maternal depression, measured via the Edinburgh Post-Natal Depression Scale | Measured from 32-35 weeks fetal gestational age - 24 months offspring age |
| Maternal anxiety | Maternal anxiety, measured via State-Trait Anxiety Inventory | Measured from 32-35 weeks fetal gestational age - 24 months offspring age |
| Maternal Perceived Stress | Maternal Perceived Stress, measured via the Perceived Stress Scale (PSS-10) | Measured from 32-35 weeks fetal gestational age - 24 months offspring age |
| Maternal Empowerment | Maternal empowerment, measured via the SWPER Global Survey | Measured from 32-35 weeks fetal gestational age - 24 months offspring age |
| Breastmilk micronutrient analysis | Breastmilk micronutrient analysis, measured via maternal breastmilk samples | 4 months offspring age |
| Maternal iron status | Maternal iron status, measured via hemoglobin, ferritin and TSAT | 32 - 35 weeks fetal gestational age |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |