PretermNCT01443195
Iron Metabolism in Small Pre Term Newborns
A study testing Iron preparation in people with Preterm and Iron Metabolism, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may persist into adulthood and may not be corrected by restoration of normal iron levels. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Preterm, Iron Metabolism, Iron Overload
- What is being tested?
- Iron preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to 31 Dec 2020
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very Low Birth Weight and / or borne at 30 weeks or less of gestational age that are scheduled to receive enteral iron supplementation as part of the standard protocol currently used by the Neonatal Intensive Care Unit.
- Birth weight will be not an inclusion or exclusion criteria for preterms born at 30 weeks or less.
Who cannot join
- Major physical anomalies,
- renal or cardiac diseases,
- newborns that underwent major surgery during the study period,
- acute or chronic fetal blood loss,
- hemolytic anemia,
- refusal to receive parental consent.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, 18101
About this study
Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may persist into adulthood and may not be corrected by restoration of normal iron levels.
Iron overload remains a significant concern in preterm infants because they have low levels of iron-binding proteins and immature antioxidant systems.
The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the iron supplementation practice for VLBW preterm infants as implemented in the Neonatal Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.
Read the detailed description
Primary objectives
- The aim of the study is to investigate the presence and level of Cryptic LPI in pre term infants plasma before and during enteral iron supplementation.
- To assess the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)
- To identify which preterm infants are at risk for iron deficiency or iron overload.
- To investigate laboratory tests, Hepcidin and CHr, for the assessment of iron metabolism in preterm infants.
Secondary objectives To review the current guidelines in use for monitoring iron status and prevention of iron deficiency in VLWP.
To implement future new guidelines for monitoring iron therapy and iron supplementation in pre terms infants if the results suggest changes in the current policy.
Treatment guidelines:
Erythropoietin will not be administrated. Restrictive red cell transfusion guidelines will be followed. All the premature infants included in the study will receive Vitamin E supplementation as the currently used in the NICU ward.
Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal
Patients and Methods Study population: all newborn infants VLBW and or borne at 30 weeks or less of gestational age admitted at the Ha'Emek Medical Center, NICU will be screened for study eligibility. The estimate number of patients that will be included in the study is 50 during a period of one year
Inclusion criteria:
VLBW and / or borne at 30 weeks or less of gestational age that are scheduled to receive enteral iron supplementation as part of the standard protocol currently used by the NICU. Birth weight will be not an inclusion or exclusion criteria for preterms born at 30 weeks or less.
Exclusion criteria: Major physical anomalies, renal or cardiac diseases, newborns that underwent major surgery during the study period, acute or chronic fetal blood loss, hemolytic anemia, refusal to receive parental consent.
Laboratory analyses:
Complete blood count including reticulocyte count and CHr. Serum iron, Transferrin, C Reactive Protein (CRP), erythropoietin, ferritin Serum Hepcidin and serum Cryptic LPI.
The blood samples will be obtained 3 hs after oral iron administration. The blood tests will be collected at same time of necessary routine blood tests.
The serum will be collected at last 72 hs apart of clinical events: sepsis, NEC Necrotizing Enterocolitis, Intra ventricular hemorrhage, severe illness and or blood transfusions.
Complete blood count including reticulocyte count and CHr (0.5 cc of blood in EDTA), will be performed on a cell counter at Ha'Emek Medical Center laboratory.
Serum laboratory analyses 2.5 cc of blood will be centrifuged (no more than 2 h after extraction) 0.25 cc of serum will be conserved at -700 C for the hepcidin analysis, 1 cc of serum will be conserved at -700 C for the Cryptic LPI analysis.
Serum iron, Transferrin, C Reactive Protein (CRP), erythropoietin and ferritin analysis will be performed at Ha'Emek Medical Center laboratory in the day of blood extraction immediately after blood centrifugation ( 0.5 cc of serum).
Iron saturation will be calculated from serum iron and transferrin results. Serum hepcidin will be measured by ELISA using the kit EIA-4705, DRG Instruments GmbH, Germany, Frauenbergstr at Ha'Emek Medical Center laboratory following the kit instructions.
Serum Cryptic LPI will measured by Aferrix Ltd, Rehovot, Israel.
Serum samples will be obtained at 3 different times:
- Before starting iron supplementation (maximum one week before).
- At the beginning of iron supplementation in order to assess early signs of erythropoiesis, iron overload or free iron (day 4 - 7 days of supplementation).
- Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation).
Demographic and perinatal data will be collected, the data will include:
Ethnic origin, gender, gestational age, birth weight, Apgar score, adverse events during the neonatal period including mechanical ventilation, infections, antibiotic therapy and jaundice.
Number and amount of blood transfusions, Amount of blood obtained for routine analysis calculated by the number of blood tests.
Time of introduction of enteral feeding, kind and daily amount of human milk or formula, and amount of daily iron intake through diet.
Time of iron supplementation, dose change, days without iron supplementation will be summarized. Accumulative amount of iron supplemented till discharge, calculated by mean iron supplementation per day and per grams of weight gain will also summarized.
Follow-up of weight gain. Perinatal morbidity, and complications. Adverse reactions related to iron treatment: skin rash, vomiting, bloody stools and NEC.
Maternal last red blood count before admission for delivery will be recorded. Maternal iron, transferrin, ferritin level and Hb electrophoresis if present in maternal records,
- Conditions
- Preterm, Iron Metabolism, Iron Overload
- Being tested
- Iron preparation
- Medical subject headings
- Premature Birth, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron preparationDrug
Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal. Serum samples will be obtained at 3 different times:
- Before starting iron supplementation (maximum one week before).
- At the beginning of iron supplementation in order to assess early signs of erythropoiesis, iron overload or free iron (day 4 - 7 days of supplementation).
- Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation).
| Study group | Role | What they receive |
|---|---|---|
| Iron suplementation | Experimental | Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal Receives: Drug: Iron preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload.
Assessment of the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)and identify which preterm infants are at risk for iron deficiency or iron overload.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startOct 2011
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443195
- Sponsor's protocol ID
- 0035-11-EMC
- Status last verified
- Oct 2019
- First submitted
- 27 Sep 2011
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Metabolism in Small Pre Term Newborns
- ClinicalTrials.gov ID
- NCT01443195
- Acronym / sponsor ID
- 0035-11-EMC
- Conditions
- Preterm, Iron Metabolism, Iron Overload
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Sep 2011 (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.
Iron is an essential micronutrient that plays an important role in cellular functions of all microorganisms. Both iron deficiency and iron excess during the early weeks of life can have severe effects on neurodevelopment that may persist into adulthood and may not be corrected by restoration of normal iron levels.
Iron overload remains a significant concern in preterm infants because they have low levels of iron-binding proteins and immature antioxidant systems.
The aim of the study is to evaluate if iron supplementation is required/necessary in VLBW Very Low Birth Weight (less than 1500 grams) and to assess the efficacy and safety of the iron supplementation practice for VLBW preterm infants as implemented in the Neonatal Intensive Care Unit (NICU) at the Ha'Emek Medical Center, Afula, Israel.
Detailed description
Primary objectives
- The aim of the study is to investigate the presence and level of Cryptic LPI in pre term infants plasma before and during enteral iron supplementation.
- To assess the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)
- To identify which preterm infants are at risk for iron deficiency or iron overload.
- To investigate laboratory tests, Hepcidin and CHr, for the assessment of iron metabolism in preterm infants.
Secondary objectives To review the current guidelines in use for monitoring iron status and prevention of iron deficiency in VLWP.
To implement future new guidelines for monitoring iron therapy and iron supplementation in pre terms infants if the results suggest changes in the current policy.
Treatment guidelines:
Erythropoietin will not be administrated. Restrictive red cell transfusion guidelines will be followed. All the premature infants included in the study will receive Vitamin E supplementation as the currently used in the NICU ward.
Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal
Patients and Methods Study population: all newborn infants VLBW and or borne at 30 weeks or less of gestational age admitted at the Ha'Emek Medical Center, NICU will be screened for study eligibility. The estimate number of patients that will be included in the study is 50 during a period of one year
Inclusion criteria:
VLBW and / or borne at 30 weeks or less of gestational age that are scheduled to receive enteral iron supplementation as part of the standard protocol currently used by the NICU. Birth weight will be not an inclusion or exclusion criteria for preterms born at 30 weeks or less.
Exclusion criteria: Major physical anomalies, renal or cardiac diseases, newborns that underwent major surgery during the study period, acute or chronic fetal blood loss, hemolytic anemia, refusal to receive parental consent.
Laboratory analyses:
Complete blood count including reticulocyte count and CHr. Serum iron, Transferrin, C Reactive Protein (CRP), erythropoietin, ferritin Serum Hepcidin and serum Cryptic LPI.
The blood samples will be obtained 3 hs after oral iron administration. The blood tests will be collected at same time of necessary routine blood tests.
The serum will be collected at last 72 hs apart of clinical events: sepsis, NEC Necrotizing Enterocolitis, Intra ventricular hemorrhage, severe illness and or blood transfusions.
Complete blood count including reticulocyte count and CHr (0.5 cc of blood in EDTA), will be performed on a cell counter at Ha'Emek Medical Center laboratory.
Serum laboratory analyses 2.5 cc of blood will be centrifuged (no more than 2 h after extraction) 0.25 cc of serum will be conserved at -700 C for the hepcidin analysis, 1 cc of serum will be conserved at -700 C for the Cryptic LPI analysis.
Serum iron, Transferrin, C Reactive Protein (CRP), erythropoietin and ferritin analysis will be performed at Ha'Emek Medical Center laboratory in the day of blood extraction immediately after blood centrifugation ( 0.5 cc of serum).
Iron saturation will be calculated from serum iron and transferrin results. Serum hepcidin will be measured by ELISA using the kit EIA-4705, DRG Instruments GmbH, Germany, Frauenbergstr at Ha'Emek Medical Center laboratory following the kit instructions.
Serum Cryptic LPI will measured by Aferrix Ltd, Rehovot, Israel.
Serum samples will be obtained at 3 different times:
- Before starting iron supplementation (maximum one week before).
- At the beginning of iron supplementation in order to assess early signs of erythropoiesis, iron overload or free iron (day 4 - 7 days of supplementation).
- Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation).
Demographic and perinatal data will be collected, the data will include:
Ethnic origin, gender, gestational age, birth weight, Apgar score, adverse events during the neonatal period including mechanical ventilation, infections, antibiotic therapy and jaundice.
Number and amount of blood transfusions, Amount of blood obtained for routine analysis calculated by the number of blood tests.
Time of introduction of enteral feeding, kind and daily amount of human milk or formula, and amount of daily iron intake through diet.
Time of iron supplementation, dose change, days without iron supplementation will be summarized. Accumulative amount of iron supplemented till discharge, calculated by mean iron supplementation per day and per grams of weight gain will also summarized.
Follow-up of weight gain. Perinatal morbidity, and complications. Adverse reactions related to iron treatment: skin rash, vomiting, bloody stools and NEC.
Maternal last red blood count before admission for delivery will be recorded. Maternal iron, transferrin, ferritin level and Hb electrophoresis if present in maternal records,
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron suplementation | Experimental | Drug: Iron preparationIron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Very Low Birth Weight and / or borne at 30 weeks or less of gestational age that are scheduled to receive enteral iron supplementation as part of the standard protocol currently used by the Neonatal Intensive Care Unit.
- Birth weight will be not an inclusion or exclusion criteria for preterms born at 30 weeks or less.
Key exclusion criteria (6 listed)
- Major physical anomalies,
- renal or cardiac diseases,
- newborns that underwent major surgery during the study period,
- acute or chronic fetal blood loss,
- hemolytic anemia,
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 preparationIron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal. Serum samples will be obtained at 3 different times: 1. Before starting iron supplementation (maximum one week before). 2. At the beginning of iron supplementation in order to assess early signs of erythropoiesis, iron overload or free iron (day 4 - 7 days of supplementation). 3. Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation). | Drug | Iron suplementation |
Primary outcome
Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload.
Time frame: One year
Assessment of the iron status in preterm infants and correlated them with clinical parameters: the blood transfusions given and the amount of blood obtained for routine laboratory analysis, and amount of daily iron intake through diet (human milk or formula)and identify which preterm infants are at risk for iron deficiency or iron overload.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron preparation in people with Preterm and Iron Metabolism, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 2 inclusion and 6 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 1 Nov 2019. 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 Israel. 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?
Results are not available in the source record.
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?
Assessment of iron status in preterm infants and identify which preterm infants are at risk for iron deficiency or iron overload. (time frame: One year). 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 1 Nov 2019.