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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Ahmed Hashem contact

01553198012

ghh32539@gmail.com

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.

  1. 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.

  1. First posted24 Aug 2022
  2. Study start19 Aug 2022 (estimated)
  3. Primary completion12 Jan 2023 (estimated)
  4. Study completion22 Dec 2023 (estimated)

Resources

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)
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

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.

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