Iron DeficiencyNCT00458068
Early Versus Late Enteral Iron in Infants Less Than 1301 Grams
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: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency. Hypothesis: Preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended. Read more about this study
- Who is it for?
- Ages 3 to 7 days
- Conditions the study is for
- Iron Deficiency, Anemia of Prematurity
- What is being tested?
- Oral administration of ferrous sulphate
- Type of treatment
- Pill or oral medicine
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- Jun 1996to Sep 1999
- 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 3 to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn infant
- Birth weight of <1301 g
- 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: Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams
Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.
Hypothesis: Preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended.
Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron supplementation may reduce the incidence of iron deficiency and the need for late blood transfusions.
Read the detailed description
Objectives. To examine whether early enteral iron supplementation (EI) would improve serum ferritin as a measure of nutritional iron status at 2 months of age and would prevent definite iron deficiency (ID) in infants with a birth weight of <1301 g. Methods. Infants were randomly assigned to receive enteral iron supplementation of 2 to 6 mg/kg/day as soon as enteral feedings of >100 mL/kg/day were tolerated (EI) or at 61 days of life (late enteral iron supplementation [LI]). Nutritional iron status was assessed: 1) at birth, 2) at 61 days of life, 3) when the infants reached a weight of 1.6 times birth weight, and 4) before blood was transfused at a hematocrit of <.25. ID was defined by any one of the following criteria: ferritin, <12 mg/L; transferrin saturation, <17%; or increase of absolute reticulocyte counts by >50% one week after the onset of enteral iron supplementation. Restrictive red cell transfusion guidelines were followed and all transfusions were documented. Erythropoietin was not administered. The primary outcome variables were: 1) ferritin at 61 days and 2) the number of infants with ID. Results. Ferritin at 61 days was not different between the groups. Infants in the LI group were more often iron-deficient (26/65 vs 10/68) and received more blood transfusions after day 14 of life. No adverse effects of EI were noted. Conclusions. EI is feasible and probably safe in infants with birth weight <1301 g. EI may reduce the incidence of ID and the number of late blood transfusions. ID may occur in very low birth weight infants despite early supplementation with iron and should be considered in the case of progressive anemia. Pediatrics 2000; 106:700 -706; preterm infant, iron supplementation, iron deficiency, blood transfusion.
- Conditions
- Iron Deficiency, Anemia of Prematurity
- Being tested
- Oral administration of ferrous sulphate
- Keywords
- preterm infant, iron supplementation, iron deficiency, blood transfusion
- 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 (7)
Transferrin-Saturation
Hematocrit at day 61
Reticulocyte count at day 61
Mean corpuscular volume at day 61
Mean corpuscular hemoglobin at day 61
Number of infants who required transfusions at days 14 to 68
Blood volume transfused at days 14 to 68
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 startJun 1996
- Study completionSep 1999
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
- 126 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
- NCT00458068
- Sponsor's protocol ID
- UL-NEO-IRON-1
- Status last verified
- Apr 2007
- First submitted
- 6 Apr 2007
- Last updated
- 9 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Franz AR, Mihatsch WA, Sander S, Kron M, Pohlandt F. Prospective randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams. Pediatrics. 2000 Oct;106(4):700-6. doi: 10.1542/peds.106.4.700.
PubMed 11015511
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
- Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams
- ClinicalTrials.gov ID
- NCT00458068
- Acronym / sponsor ID
- UL-NEO-IRON-1
- Conditions
- Iron Deficiency, Anemia of Prematurity
- Keywords
- preterm infant, iron supplementation, iron deficiency, blood transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Jun 1996
- Study completion
- Sep 1999 (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: Preterm infants are at risk of iron deficiency. The smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.
Hypothesis: Preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended.
Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron supplementation may reduce the incidence of iron deficiency and the need for late blood transfusions.
Detailed description
Objectives. To examine whether early enteral iron supplementation (EI) would improve serum ferritin as a measure of nutritional iron status at 2 months of age and would prevent definite iron deficiency (ID) in infants with a birth weight of <1301 g. Methods. Infants were randomly assigned to receive enteral iron supplementation of 2 to 6 mg/kg/day as soon as enteral feedings of >100 mL/kg/day were tolerated (EI) or at 61 days of life (late enteral iron supplementation [LI]). Nutritional iron status was assessed: 1) at birth, 2) at 61 days of life, 3) when the infants reached a weight of 1.6 times birth weight, and 4) before blood was transfused at a hematocrit of <.25. ID was defined by any one of the following criteria: ferritin, <12 mg/L; transferrin saturation, <17%; or increase of absolute reticulocyte counts by >50% one week after the onset of enteral iron supplementation. Restrictive red cell transfusion guidelines were followed and all transfusions were documented. Erythropoietin was not administered. The primary outcome variables were: 1) ferritin at 61 days and 2) the number of infants with ID. Results. Ferritin at 61 days was not different between the groups. Infants in the LI group were more often iron-deficient (26/65 vs 10/68) and received more blood transfusions after day 14 of life. No adverse effects of EI were noted. Conclusions. EI is feasible and probably safe in infants with birth weight <1301 g. EI may reduce the incidence of ID and the number of late blood transfusions. ID may occur in very low birth weight infants despite early supplementation with iron and should be considered in the case of progressive anemia. Pediatrics 2000; 106:700 -706; preterm infant, iron supplementation, iron deficiency, blood transfusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 3 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Inborn infant
- Birth weight of <1301 g
- Admitted between June 1996 and June 1999
Key exclusion criteria (4 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.
7 secondary outcomes
Transferrin-Saturation
Hematocrit at day 61
Reticulocyte count at day 61
Mean corpuscular volume at day 61
Mean corpuscular hemoglobin at day 61
Number of infants who required transfusions at days 14 to 68
Blood volume transfused at days 14 to 68
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.
- Results publication: PubMed 11015511Franz AR, Mihatsch WA, Sander S, Kron M, Pohlandt F. Prospective randomized trial of early versus late enteral iron supplementation in infants with a birth weight of less than 1301 grams. Pediatrics. 2000 Oct;106(4):700-6. doi: 10.1542/peds.106.4.700.
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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 3 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: 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 NCT00458068, 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.