Iron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's HospitalNCT05513105
Iron Study of Neonates Iron Study of Neonates Birth in Assuit University Children's Hospital
An observational study of Iron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's Hospital, run by Assiut University.
Trial summary
Iron study of neonates: factors affecting and impact on their health status at birth in Assuit University Children's Hospital Read more about this study
- Who is it for?
- Ages 1 minute to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's Hospital
- What is being tested?
- Iron study of neonates
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2022to 22 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: NeonateS birth in Assuit University Children's Hospital
Who may be able to join
- Neonates delivered at women Assuit university hospital either ceserian or normal vaginal delivery
Who cannot join
- *Congenital malformation
- history of genetics or chromosomal disease
- history of inborn errors of metabolic disease
- Neonates who we cannot catch cord blood sample immediate afer birth
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Iron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's Hospital
Iron study of neonates: factors affecting and impact on their health status at birth in Assuit University Children's Hospital
Read the detailed description
Iron is an essential micronutrient that plays a significant role in critical cellular functions in all organ systems in all species. Iron is particularly vital for early brain growth and function in humans since it supports neuronal and glial energy metabolism, neurotransmitter synthesis and myelination [1-5]. The need to establish standard curves for cord serum ferritin concentrations throughout the third trimester of pregnancy is based on the risk of developing brain iron deficiency as storage iron pools become depleted in certain gestational conditions [6-8]. Iron deficiency during the fetal or postnatal periods can alter brain structure, neurochemistry and cognitive functioning, and lead to long-term cognitive and motor impairment that cannot be corrected by iron supplementation [9-11]. Newborn infants with the lowest quartile of cord ferritin concentrations (<76 μg/l) have impaired mental and psychomotor function at school age [12]. Iron-deficient infants of diabetic mothers (IDM) with low neonatal ferritin concentrations (<35 μg/l) have impaired auditory recognition memory processing at birth compared with iron-sufficient IDM (ferritin >35 μg/l) [13]. Pre-term infants with low serum ferritin concentrations (<75 μg/l) at 37 weeks post-conception have abnormal neurologic reflexes [14].
Direct measurement of brain iron in newborn infants is not currently feasible.Total body iron and iron storage estimates are based on measurements of serum markers, such as hemoglobin (Hgb) and ferritin concentrations [15]. Serumferritin concentration has been used as a standard measurement of iron stores ininfants, children and adults [16-19]. The relationships between ferritin concentrations and total body storage iron in these populations are well established. In adults, 1 μg/l of serum ferritin is equivalent to 8-10 mg ofstorage iron [20]. In newborn infants, the ratio of serum ferritin to liver nonheme iron concentration is closer to 1:2.7 [21]. In spite of the wide availability of serum ferritin as a screening test, normative data at birth, as a function of specific gestational ages from 23 to 41 weeks,
Low serum ferritin concentrations are seen only in iron deficiency. Elevated ferritin concentrations in the newborn can be a consequence of neonatal hemochromatosis, excessiveiron administration or RBC transfusions. Serum ferritin concentrations are also elevated during periods of infection,inflammation and neoplasia. Under these conditions, serum ferritin behaves as an acute-phase reactant that can mask the diagnosis of iron deficiency [22]. Iron requirements in women are significantly higher in the pregnant state than in the nonpregnant state. The total iron requirement of a full-term pregnancy is approximately 1,000 mg [23]. Iron requirements for pregnant women increase significantly in the second and third trimesters, with the expansion of maternal blood volume and fetal red cell mass [23]. The fetus accumulates iron at a rate of 1.35 mg/kg of fetal weight in the third trimester, maintaining an average iron content of 75 mg/kg of body weight during the last trimester [24.25]. At term, 70-80% of fetal iron is present in RBCs as Hgb, 10% in tissues as myoglobin and cytochromes, and the remaining 10-15% stored in reticuloendothelial and parenchymal tissues as ferritin and hemosiderin [24]. The placenta serves as the regulatable conduit for maternal-fetal iron transport. The amount of iron passing through the placenta increases with gestation. Iron is transferred against a concentration gradient from the placenta to the fetus, especially during the later stages of pregnancy. The placenta can also serve as a storage organ for iron during pregnancy.
Factors that influence neonatal ferritin concentration at birth include duration of gestation, fetal sex, maternal iron status and conditions altering maternal-fetal iron exchange.. At- or near-term female newborn infants have higher cord serum ferritin concentrations than male
- Being tested
- Iron study of neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron study of neonatesDiagnostic test
Blood sambles
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron study of neonates
describes iron study of neonates affecting health status at birth
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start19 Aug 2022 (estimated)
- Primary completion12 Jan 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's HospitalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Hashem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513105
- Sponsor's protocol ID
- Asiout
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's Hospital
- ClinicalTrials.gov ID
- NCT05513105
- Acronym / sponsor ID
- Asiout
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 Aug 2022 (estimated)
- Primary completion
- 12 Jan 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron study of neonates: factors affecting and impact on their health status at birth in Assuit University Children's Hospital
Detailed description
Iron is an essential micronutrient that plays a significant role in critical cellular functions in all organ systems in all species. Iron is particularly vital for early brain growth and function in humans since it supports neuronal and glial energy metabolism, neurotransmitter synthesis and myelination [1-5]. The need to establish standard curves for cord serum ferritin concentrations throughout the third trimester of pregnancy is based on the risk of developing brain iron deficiency as storage iron pools become depleted in certain gestational conditions [6-8]. Iron deficiency during the fetal or postnatal periods can alter brain structure, neurochemistry and cognitive functioning, and lead to long-term cognitive and motor impairment that cannot be corrected by iron supplementation [9-11]. Newborn infants with the lowest quartile of cord ferritin concentrations (<76 μg/l) have impaired mental and psychomotor function at school age [12]. Iron-deficient infants of diabetic mothers (IDM) with low neonatal ferritin concentrations (<35 μg/l) have impaired auditory recognition memory processing at birth compared with iron-sufficient IDM (ferritin >35 μg/l) [13]. Pre-term infants with low serum ferritin concentrations (<75 μg/l) at 37 weeks post-conception have abnormal neurologic reflexes [14].
Direct measurement of brain iron in newborn infants is not currently feasible.Total body iron and iron storage estimates are based on measurements of serum markers, such as hemoglobin (Hgb) and ferritin concentrations [15]. Serumferritin concentration has been used as a standard measurement of iron stores ininfants, children and adults [16-19]. The relationships between ferritin concentrations and total body storage iron in these populations are well established. In adults, 1 μg/l of serum ferritin is equivalent to 8-10 mg ofstorage iron [20]. In newborn infants, the ratio of serum ferritin to liver nonheme iron concentration is closer to 1:2.7 [21]. In spite of the wide availability of serum ferritin as a screening test, normative data at birth, as a function of specific gestational ages from 23 to 41 weeks,
Low serum ferritin concentrations are seen only in iron deficiency. Elevated ferritin concentrations in the newborn can be a consequence of neonatal hemochromatosis, excessiveiron administration or RBC transfusions. Serum ferritin concentrations are also elevated during periods of infection,inflammation and neoplasia. Under these conditions, serum ferritin behaves as an acute-phase reactant that can mask the diagnosis of iron deficiency [22]. Iron requirements in women are significantly higher in the pregnant state than in the nonpregnant state. The total iron requirement of a full-term pregnancy is approximately 1,000 mg [23]. Iron requirements for pregnant women increase significantly in the second and third trimesters, with the expansion of maternal blood volume and fetal red cell mass [23]. The fetus accumulates iron at a rate of 1.35 mg/kg of fetal weight in the third trimester, maintaining an average iron content of 75 mg/kg of body weight during the last trimester [24.25]. At term, 70-80% of fetal iron is present in RBCs as Hgb, 10% in tissues as myoglobin and cytochromes, and the remaining 10-15% stored in reticuloendothelial and parenchymal tissues as ferritin and hemosiderin [24]. The placenta serves as the regulatable conduit for maternal-fetal iron transport. The amount of iron passing through the placenta increases with gestation. Iron is transferred against a concentration gradient from the placenta to the fetus, especially during the later stages of pregnancy. The placenta can also serve as a storage organ for iron during pregnancy.
Factors that influence neonatal ferritin concentration at birth include duration of gestation, fetal sex, maternal iron status and conditions altering maternal-fetal iron exchange.. At- or near-term female newborn infants have higher cord serum ferritin concentrations than male
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 minute to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- NeonateS birth in Assuit University Children's Hospital
Key inclusion criteria (1 listed)
- Neonates delivered at women Assuit university hospital either ceserian or normal vaginal delivery
Key exclusion criteria (4 listed)
- *Congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron study of neonatesBlood sambles | Diagnostic test | – |
Primary outcome
Iron study of neonates
Time frame: 3years
describes iron study of neonates affecting health status at birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's Hospital, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hashem (01553198012, ghh32539@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron study of neonates (time frame: 3years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.