Iron in infant formula for Infant Development

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Colorado Anschutz Medical Campus, Aurora, CO
Iron in infant formula - Other
Eligibility
< 18
All Sexes
Eligible conditions
Infant Development

Study Summary

This study is evaluating whether iron content in infant formula may have an effect on gut development.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Iron in infant formula will improve 1 primary outcome and 6 secondary outcomes in patients with Infant Development. Measurement will happen over the course of at baseline (birth) and end of intervention (4 months).

Month 4
Immunity: soluble CD14
Inflammation: c-reactive protein
Iron status: ferritin
Iron status: hepcidin
Iron status: soluble transferrin receptor
Month 4
Gut microbiota
Month 4
Sleep patterns: duration

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Standard iron arm

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Iron In Infant Formula is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Standard iron arm
Other
Participants randomized to this arm will consume infant formula containing 12 mg/L of iron, equivalent to the standard iron content in U.S. infant formula
Low iron arm
Other
Participants randomized to this arm will consume infant formula containing 5 mg/L of iron, equivalent to the standard iron content in European infant formula

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: birth to 4 months of age
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly birth to 4 months of age for reporting.

Closest Location

University of Colorado Anschutz Medical Campus - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Healthy new born infants

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes infant development?

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Infants have their own unique way of development. We will see their growth in the womb, the process of birth, infancy and adolescence, and their development and ways of thinking and behaving. It is important to understand infants' development as we work to improve our services and treatment for babies, children and adults with disabilities and developmental disability. We are learning more about the developing brain through modern research that looks into brain imaging and medical testing. This is an exciting new area of study. The goal of this research is to understand what is going on in the developing brain as we observe them from birth, through to adolescence and even adulthood. Our research will give us new insights into how children develop and the causes of development.

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What are the signs of infant development?

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The signs of infant development included delayed breast feeding, breast feeding difficulties, feeding solids earlier than usual, and vomiting. The signs are most likely attributable to early or insufficient care.

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What is infant development?

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Although the developmental processes of infants can be measured in different ways, we see the different perspectives as representing a unified picture of the underlying biological factors that shape the development of their cognitive, emotional and motor systems. The developmental processes include not only the development of brain, but also the development of the body's endocrine and immune systems, which affect the brain functioning. Because the brain of infants is still developing in many aspects but the brain structures are more similar to adults than other animals, it is important that we know how the brain develops in the early stages of postnatal life.

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Can infant development be cured?

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Infants can be diagnosed with neurodevelopmental disorders in the first and second months of life. These interventions are based on developmental research and supported by the [International Infant Developmental Symposium] (http://www.iisd.org/). Physicians can [participate in the meetings of the symposium and/or attend the general program] for more information on interventions that meet the developmental needs of infants and toddlers.

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How many people get infant development a year in the United States?

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Each year, around 7 million US infants will be born. It is likely that many more infants will develop problems during this time. The US infant is a growing health concerns. The National Institute of Child Health and Human Development has developed an infant developmental monitoring program which could help identify infants at risk of later developmental problems.

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What are common treatments for infant development?

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Many families with children with developmental delays, including those with autistic spectrum disorder, find that a team of professionals can help get the child ready and functioning at optimum levels in the community. The following sections will address the different types of therapy that have been shown to be extremely effective in helping children with developmental delays, and will review some of the specific treatment paradigms used in these cases.

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What does iron in infant formula usually treat?

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The conclusions of this study have practical implications for both practitioners and parents. Parents of formula fed infants could benefit from further iron supplementation. Practitioners also could benefit from further studies into the usefulness and cost-effectiveness of iron supplementation.

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Does infant development run in families?

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Developmental outcomes at ages 18months and four years show no strong evidence of intrafamilial effects. The evidence of shared environmental factors is strongest when comparing the two measures across children in the same family.

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What is iron in infant formula?

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Infant formulas should contain iron, but the amount and the source of iron in iron supplements are both important questions for mothers. [What is iron in formula? A review. J Pediatr Surg 36:1045-1046 (2005); Clinical and Laboratory Diagnosis of Infestation with Group A Streptococcus in Infants.

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Is iron in infant formula typically used in combination with any other treatments?

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[Formula_1<nowiki>'s</nowiki> composition was comparable with the current US Recommended Dietary Allowance of iron (RIAL) (19 mg/day, 18 IU/mL) in breast milk (19 mg/day, 22 IU/mL) but differed from the World Health Organization (WHO) minimum threshold amount requirements (18 mg/day, 17 mg/L) for adult women. Formula_1 contained in excess of the RIAL is a risk factor for children < 2 years of age, even in the presence of breast-feed].

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What is the primary cause of infant development?

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The current data suggest that the principal underlying mechanism of infant neurobehavioral development is one of the developmental disturbances of the hypothalamic–pituitary–adrenomedullary axis (HPA axis) which is associated with neurodevelopmental disturbances.

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What is the average age someone gets infant development?

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Age of diagnosis for infant developmental delays ranges from infancy to preschool age. As for individuals with infantile development delays, children are most likely to be diagnosed between 2 and 4 years old. Those with infant developmental delays in school age range from 5 to 10 years.

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