Iron DeficiencyNCT00457990
Neurodevelopment After Early Iron Supplementation
A study testing Oral administration of ferrous sulphate in people with Iron Deficiency and Anemia of Prematurity, run by University of Ulm at 1 site in Germany.
Trial summary
Background: Iron deficiency in early childhood may impair neurodevelopment. Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants. Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Iron Deficiency, Anemia of Prematurity, Neurodevelopmental Delay
- What is being tested?
- Oral administration of ferrous sulphate
- Type of treatment
- Pill or oral medicine
- How many people
- 204 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2002to Dec 2005
- Phase
- Interventional
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- inborn infants with a birth weight of <1301g admitted between June 1996 and June 1999
Who cannot join
- major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 5.3 Years Corrected Age
Background: Iron deficiency in early childhood may impair neurodevelopment.
Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.
Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.
Read the detailed description
Children with a birth weight of < 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor Function Classification Scale (GMFCS) at the age of school entry.
Severe disability was defined as any of the following: any abnormal neurological examination associated with a severely impaired mobility (GMFCS>1), severe cognitive impairment (mental processing composite (MPC) <51), hearing loss requiring amplification, or blindness. The absence of disability was defined as normal neurological examination, normal mobility (GMFCS=0), and normal cognitive development (MPC>85) and the absence of any severe hearing and visual impairment.
- Being tested
- Oral administration of ferrous sulphate
- Keywords
- Neurocognitive outcome, preterm infant, very low birth weight, iron deficiency, iron supplementation
- Medical subject headings
- Iron Deficiencies, Anemia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of ferrous sulphateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ferritin at 61 days of life
the number of infants who fulfilled the criteria of ID at any time throughout the study.
Secondary outcomes (4)
Neurological Status
Mental Processing Composite (Kaufmann Assessment Battery for Children)
Disability Status
Behavioural Problems
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startApr 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 204 participants
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Investigators
- Axel R Franz, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457990
- Sponsor's protocol ID
- UL-NEO-IRON-2
- Status last verified
- Apr 2007
- First submitted
- 6 Apr 2007
- Last updated
- 9 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinmacher J, Pohlandt F, Bode H, Sander S, Kron M, Franz AR. Randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams: neurocognitive development at 5.3 years' corrected age. Pediatrics. 2007 Sep;120(3):538-46. doi: 10.1542/peds.2007-0495.
PubMed 17766527
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301g - Neurocognitive Development at 5.3 Years Corrected Age
- ClinicalTrials.gov ID
- NCT00457990
- Acronym / sponsor ID
- UL-NEO-IRON-2
- Keywords
- Neurocognitive outcome, preterm infant, very low birth weight, iron deficiency, iron supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Dec 2005 (actual)
- First posted
- 9 Apr 2007 (estimated)
- 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.
Background: Iron deficiency in early childhood may impair neurodevelopment.
Aim: To examine whether early iron supplementation improved neurodevelopment in preterm infants.
Method: Children who participated in a clinical trial of iron supplementation were invited for a neurodevelopmental follow-up examination at the time of school entry.
Detailed description
Children with a birth weight of < 1301g who participated in a randomized controlled trial of early versus late enteral iron supplementation were evaluated applying a standardized neurological evaluation, the Kaufmann Assessment Battery for Children, and the Gross Motor Function Classification Scale (GMFCS) at the age of school entry.
Severe disability was defined as any of the following: any abnormal neurological examination associated with a severely impaired mobility (GMFCS>1), severe cognitive impairment (mental processing composite (MPC) <51), hearing loss requiring amplification, or blindness. The absence of disability was defined as normal neurological examination, normal mobility (GMFCS=0), and normal cognitive development (MPC>85) and the absence of any severe hearing and visual impairment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- inborn infants with a birth weight of <1301g admitted between June 1996 and June 1999
Key exclusion criteria (1 listed)
- major anomalies, hemolytic disease, twin-to-twin transfusion syndrome, missing parental consent
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 |
|---|---|---|
| Oral administration of ferrous sulphate | Drug | – |
Primary outcome
ferritin at 61 days of life
the number of infants who fulfilled the criteria of ID at any time throughout the study.
4 secondary outcomes
Neurological Status
Mental Processing Composite (Kaufmann Assessment Battery for Children)
Disability Status
Behavioural Problems
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2007.
- Derived from this study: PubMed 17766527Steinmacher J, Pohlandt F, Bode H, Sander S, Kron M, Franz AR. Randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams: neurocognitive development at 5.3 years' corrected age. Pediatrics. 2007 Sep;120(3):538-46. doi: 10.1542/peds.2007-0495.
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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.
Axel R Franz, MD principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral administration of ferrous sulphate in people with Iron Deficiency and Anemia of Prematurity, run by University of Ulm at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 9 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ferritin at 61 days of life. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457990, which also lists 1 linked publication.
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 9 Apr 2007.