Premature BirthNCT02743572
Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
A study testing iron sucrose-1, iron sucrose-2 and iron sucrose-3 in people with Premature Birth, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine whether iron-fortified PN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Premature Birth
- What is being tested?
- iron sucrose-1, iron sucrose-2 and iron sucrose-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to May 2017
- 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 1 hour to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with birth weight less than 2kg
- Have parenteral nutrition indication
- With written informed consent of parents or guardian
Who cannot join
- Have already used PN before randomization
- Kidney and liver function abnormal
- Have hemolytic disease
- Have hemorrhagic disease
- Have Serious congenital malformation
- Have septicemia
- Have plethora newborn
- Use PN less than ten days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Parenteral Nutrition With Iron Sucrose for Anemia in Preterm Infants: a Randomized, Double-blind Controlled Study
The purpose of this study is to determine whether iron-fortified PN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Anemia effects growing development, clinical prognosis, cognition, movement, learning ability and behavioral development.
As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select. For most preterm infants, the use of parenteral nutrition(PN) is very common during the first ten days of life, so the investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of oral nutrition; Iron-fortified PN can also improve iron store status of preterm infants. The higher concentration of iron used in this study, the larger preventative or treatment effect on preterm infants anemia; it is safe to add small dose of iron agent to PN.
Read the detailed description
Infants are at risk for anemia especially in preterm infants. Generally the smaller birth weight and gestational age, the higher anemia ate in infants. As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select.
Meeting the Inclusion Criteria of this study will be randomly divided into five groups, control group, group1 (100μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group2（200μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group3 (300μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group4 (400μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN). Iron supplementation period for more than ten days. For five groups, complete blood counts, differential counts, and reticulocyte counts were measured weekly in samples obtained, serum iron, iron protein, total iron binding force were measured at baseline and after 2 weeks. Through comparative analysis of five groups, to find iron-fortified PN whether affect anemia rate and iron storage in premature infants. The investigators also selected malondialdehyde (MDA) and 8-isoprostaglandin F2α (8-iso-PGF2α) as the investigators concerns about iron used in PN induces oxidative stress index. Iron protein determination use radioimmunoassay method, serum iron and total iron binding force determination use chemical method, MDA and 8-iso-PGF2α determination use enzyme-linked immunosorbent assay method.
The investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of parenteral nutrition; Iron-fortified PN can also improve iron store status of preterm infants. The higher concentration of iron used in this study, the larger preventative or treatment effect on preterm infants anemia.
- Conditions
- Premature Birth
- Being tested
- iron sucrose-1, iron sucrose-2, iron sucrose-3, iron sucrose-4
- Keywords
- premature infant, anemia, iron-fortification, parenteral nutrition, randomized controlled trial
- Medical subject headings
- Premature Birth, Anemia, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron sucrose-1Other
iron sucrose-1 group with PN of iron supplementation of 100μg/kg/d
iron sucrose-2Other
iron sucrose-2 group with PN of iron supplementation of 200μg/kg/d
iron sucrose-3Other
iron sucrose-3 group with PN of iron supplementation of 300μg/kg/d
iron sucrose-4Other
iron sucrose-4 group with PN of iron supplementation of 400μg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | preterm infants of this group with iron-free PN for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention |
| iron sucrose-1 | Experimental | preterm infants of this group with iron supplementation of 100μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention Receives: Other: iron sucrose-1 |
| iron sucrose-2 | Experimental | preterm infants of this group with iron supplementation of 200μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention Receives: Other: iron sucrose-2 |
| iron sucrose-3 | Experimental | preterm infants of this group with iron supplementation of 300μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention Receives: Other: iron sucrose-3 |
| iron sucrose-4 | Experimental | preterm infants of this group with iron supplementation of 400μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention Receives: Other: iron sucrose-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of iron status index before and after iron-fortified parenteral nutrition support
Measured: up to 2 weeks
Secondary outcomes (1)
Changes of iron storage index before and after iron-fortified parenteral nutrition support
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, qingya tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- qingya tang, Principal investigator, Shanghai jiaotong university affiliated xinhua hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743572
- Sponsor's protocol ID
- XH-16-002
- Status last verified
- Mar 2018
- First submitted
- 31 Mar 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chang S, Zeng L, Brouwer ID, Kok FJ, Yan H. Effect of iron deficiency anemia in pregnancy on child mental development in rural China. Pediatrics. 2013 Mar;131(3):e755-63. doi: 10.1542/peds.2011-3513. Epub 2013 Feb 11.
PubMed 23400604Singh S, Singh S, Singh PK. A study to compare the efficacy and safety of intravenous iron sucrose and intramuscular iron sorbitol therapy for anemia during pregnancy. J Obstet Gynaecol India. 2013 Mar;63(1):18-21. doi: 10.1007/s13224-012-0248-3. Epub 2012 Sep 12.
PubMed 24431594Inder TE, Clemett RS, Austin NC, Graham P, Darlow BA. High iron status in very low birth weight infants is associated with an increased risk of retinopathy of prematurity. J Pediatr. 1997 Oct;131(4):541-4. doi: 10.1016/s0022-3476(97)70058-1.
PubMed 9386655Cooke RW, Drury JA, Yoxall CW, James C. Blood transfusion and chronic lung disease in preterm infants. Eur J Pediatr. 1997 Jan;156(1):47-50. doi: 10.1007/s004310050551.
PubMed 9007491Moshtaghie M, Malekpouri P, Dinko MR, Moshtaghie AA. Changes in serum parameters associated with iron metabolism in male rat exposed to lead. J Physiol Biochem. 2013 Jun;69(2):297-304. doi: 10.1007/s13105-012-0212-9. Epub 2012 Sep 25.
PubMed 23007736Smith S. Safe administration of intravenous iron therapy. Nurs Stand. 2013 Apr 3-9;27(31):45-8. doi: 10.7748/ns2013.04.27.31.45.e5162.
PubMed 23641637Plummer ES, Crary SE, McCavit TL, Buchanan GR. Intravenous low molecular weight iron dextran in children with iron deficiency anemia unresponsive to oral iron. Pediatr Blood Cancer. 2013 Nov;60(11):1747-52. doi: 10.1002/pbc.24676. Epub 2013 Jul 6.
PubMed 23832487Heming N, Letteron P, Driss F, Millot S, El Benna J, Tourret J, Denamur E, Montravers P, Beaumont C, Lasocki S. Efficacy and toxicity of intravenous iron in a mouse model of critical care anemia*. Crit Care Med. 2012 Jul;40(7):2141-8. doi: 10.1097/CCM.0b013e31824e6713.
PubMed 22564959
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Parenteral Nutrition With Iron Sucrose for Anemia in Preterm Infants: a Randomized, Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT02743572
- Acronym / sponsor ID
- XH-16-002
- Conditions
- Premature Birth
- Keywords
- premature infant, anemia, iron-fortification, parenteral nutrition, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Apr 2016 (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.
The purpose of this study is to determine whether iron-fortified PN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Anemia effects growing development, clinical prognosis, cognition, movement, learning ability and behavioral development.
As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select. For most preterm infants, the use of parenteral nutrition(PN) is very common during the first ten days of life, so the investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of oral nutrition; Iron-fortified PN can also improve iron store status of preterm infants. The higher concentration of iron used in this study, the larger preventative or treatment effect on preterm infants anemia; it is safe to add small dose of iron agent to PN.
Detailed description
Infants are at risk for anemia especially in preterm infants. Generally the smaller birth weight and gestational age, the higher anemia ate in infants. As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select.
Meeting the Inclusion Criteria of this study will be randomly divided into five groups, control group, group1 (100μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group2（200μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group3 (300μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN), group4 (400μg/kg/d, and the highest concentration of iron is ≤0.8g/100ml PN). Iron supplementation period for more than ten days. For five groups, complete blood counts, differential counts, and reticulocyte counts were measured weekly in samples obtained, serum iron, iron protein, total iron binding force were measured at baseline and after 2 weeks. Through comparative analysis of five groups, to find iron-fortified PN whether affect anemia rate and iron storage in premature infants. The investigators also selected malondialdehyde (MDA) and 8-isoprostaglandin F2α (8-iso-PGF2α) as the investigators concerns about iron used in PN induces oxidative stress index. Iron protein determination use radioimmunoassay method, serum iron and total iron binding force determination use chemical method, MDA and 8-iso-PGF2α determination use enzyme-linked immunosorbent assay method.
The investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of parenteral nutrition; Iron-fortified PN can also improve iron store status of preterm infants. The higher concentration of iron used in this study, the larger preventative or treatment effect on preterm infants anemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –preterm infants of this group with iron-free PN for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention |
| iron sucrose-1 | Experimental | Other: iron sucrose-1preterm infants of this group with iron supplementation of 100μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention |
| iron sucrose-2 | Experimental | Other: iron sucrose-2preterm infants of this group with iron supplementation of 200μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention |
| iron sucrose-3 | Experimental | Other: iron sucrose-3preterm infants of this group with iron supplementation of 300μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention |
| iron sucrose-4 | Experimental | Other: iron sucrose-4preterm infants of this group with iron supplementation of 400μg/kg/d for more than seven days, compare erythrocyte parameters, serum iron, iron protein and MDA on baseline and after intervention |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants with birth weight less than 2kg
- Have parenteral nutrition indication
- With written informed consent of parents or guardian
Key exclusion criteria (8 listed)
- Have already used PN before randomization
- Kidney and liver function abnormal
- Have hemolytic disease
- Have hemorrhagic disease
- Have Serious congenital malformation
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 sucrose-1iron sucrose-1 group with PN of iron supplementation of 100μg/kg/d | Other | iron sucrose-1 |
| iron sucrose-2iron sucrose-2 group with PN of iron supplementation of 200μg/kg/d | Other | iron sucrose-2 |
| iron sucrose-3iron sucrose-3 group with PN of iron supplementation of 300μg/kg/d | Other | iron sucrose-3 |
| iron sucrose-4iron sucrose-4 group with PN of iron supplementation of 400μg/kg/d | Other | iron sucrose-4 |
Primary outcome
Changes of iron status index before and after iron-fortified parenteral nutrition support
Time frame: up to 2 weeks
1 secondary outcome
Changes of iron storage index before and after iron-fortified parenteral nutrition support
Time frame: up to 1 month
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 7 Mar 2018.
- Results publication: PubMed 23400604Chang S, Zeng L, Brouwer ID, Kok FJ, Yan H. Effect of iron deficiency anemia in pregnancy on child mental development in rural China. Pediatrics. 2013 Mar;131(3):e755-63. doi: 10.1542/peds.2011-3513. Epub 2013 Feb 11.
- Results publication: PubMed 24431594Singh S, Singh S, Singh PK. A study to compare the efficacy and safety of intravenous iron sucrose and intramuscular iron sorbitol therapy for anemia during pregnancy. J Obstet Gynaecol India. 2013 Mar;63(1):18-21. doi: 10.1007/s13224-012-0248-3. Epub 2012 Sep 12.
- Results publication: PubMed 9386655Inder TE, Clemett RS, Austin NC, Graham P, Darlow BA. High iron status in very low birth weight infants is associated with an increased risk of retinopathy of prematurity. J Pediatr. 1997 Oct;131(4):541-4. doi: 10.1016/s0022-3476(97)70058-1.
- Results publication: PubMed 9007491Cooke RW, Drury JA, Yoxall CW, James C. Blood transfusion and chronic lung disease in preterm infants. Eur J Pediatr. 1997 Jan;156(1):47-50. doi: 10.1007/s004310050551.
- Results publication: PubMed 23007736Moshtaghie M, Malekpouri P, Dinko MR, Moshtaghie AA. Changes in serum parameters associated with iron metabolism in male rat exposed to lead. J Physiol Biochem. 2013 Jun;69(2):297-304. doi: 10.1007/s13105-012-0212-9. Epub 2012 Sep 25.
- Results publication: PubMed 23641637Smith S. Safe administration of intravenous iron therapy. Nurs Stand. 2013 Apr 3-9;27(31):45-8. doi: 10.7748/ns2013.04.27.31.45.e5162.
- Results publication: PubMed 23832487Plummer ES, Crary SE, McCavit TL, Buchanan GR. Intravenous low molecular weight iron dextran in children with iron deficiency anemia unresponsive to oral iron. Pediatr Blood Cancer. 2013 Nov;60(11):1747-52. doi: 10.1002/pbc.24676. Epub 2013 Jul 6.
- Results publication: PubMed 22564959Heming N, Letteron P, Driss F, Millot S, El Benna J, Tourret J, Denamur E, Montravers P, Beaumont C, Lasocki S. Efficacy and toxicity of intravenous iron in a mouse model of critical care anemia*. Crit Care Med. 2012 Jul;40(7):2141-8. doi: 10.1097/CCM.0b013e31824e6713.
- Individual participant dataSharing planned: No
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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.
qingya tang principal investigator
Shanghai jiaotong university affiliated xinhua hospital
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 sucrose-1, iron sucrose-2 and iron sucrose-3 in people with Premature Birth, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 8 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 7 Mar 2018. 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 China. 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?
Changes of iron status index before and after iron-fortified parenteral nutrition support (time frame: up to 2 weeks). 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 NCT02743572, which also lists 8 linked publications.
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 7 Mar 2018.