MalnutritionPhase 4NCT02060851
Effects of Early Short-term Intravenous Iron Supplements Combined EPO in Preterm Infants
A Phase 4 study testing standard PN, Vifor and Vifor and EPO in people with Malnutrition, run by Kunshan First People's Hospital Affiliated to Jiangsu University at 1 site in China.
Trial summary
There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Malnutrition
- What is being tested?
- standard PN, Vifor and Vifor and EPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jun 2014
- Phase
- Phase 4
- 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 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian
Who cannot join
- Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants
There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.
Read the detailed description
The study was approved by the ethics committee of Xinhua Hospital, and all parents gave written informed consent.
Study Design This was a randomized, controlled, double-blind, interventional trial of iron (iron sucrose) supplementation given from age of 1 day until full 2 weeks to preterm infants in NICU, who divided into three groups, control(PN without iron and EPO), Vifor and vifor and EPOE group, according to the recommended dosage of ESPEN .
Outcome Measures General information and indicators including anemia iron storage were measured. And the same time oxidative stress indicators were monitored at age of 1day and 2 weeks.
General growth parameters including the blood sugar, liver and renal function index before and after the intervention were tested.
Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured before and after the intervention. The three groups were all peripheral blood.
Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. We used the radio-immunoassay method to test the ferritin (DADE BEHRING, Germany), the chemical method to the serum iron and the automatic biochemical analyzer (automatic biochemical analyzer, 7600, HITACH).
- Conditions
- Malnutrition
- Being tested
- standard PN, Vifor, Vifor and EPO
- Keywords
- EPO, Intravenous iron, iron storage, preterm anemia
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard PNOther
Also called a control group
Group 1: a control group who received standard PN
ViforDrug
Also called an iron-supplemented group
iron sucrose, 200 μg/kg per day, was given everyday with PN,
Vifor and EPODrug
Also called iron-supplemented combined EPO group
EPO, 400U/kg, was given twice a week (Monday and Friday). IS, 200 μg/kg per day, was given everyday with PN, and the dose was continued until 2 weeks after birth
| Study group | Role | What they receive |
|---|---|---|
| Vifor and EPO | Experimental | intravenous iron and EPO Receives: Drug: Vifor and EPO |
| control | Placebo comparator | no intravenous iron or EPO Receives: Other: standard PN |
| Vifor | Experimental | intravenous iton but no EPO Receives: Drug: Vifor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Hematological evaluation
Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood.
Measured: up to 2 weeks
Secondary outcomes (1)
Iron storage
Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunshan First People's Hospital Affiliated to Jiangsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Hua, Kunshan First People's Hospital Affiliated to Jiangsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060851
- Sponsor's protocol ID
- kunshan002
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants
- ClinicalTrials.gov ID
- NCT02060851
- Acronym / sponsor ID
- kunshan002
- Conditions
- Malnutrition
- Keywords
- EPO, Intravenous iron, iron storage, preterm anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kunshan First People's Hospital Affiliated to Jiangsu UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Feb 2014 (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.
There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.
Detailed description
The study was approved by the ethics committee of Xinhua Hospital, and all parents gave written informed consent.
Study Design This was a randomized, controlled, double-blind, interventional trial of iron (iron sucrose) supplementation given from age of 1 day until full 2 weeks to preterm infants in NICU, who divided into three groups, control(PN without iron and EPO), Vifor and vifor and EPOE group, according to the recommended dosage of ESPEN .
Outcome Measures General information and indicators including anemia iron storage were measured. And the same time oxidative stress indicators were monitored at age of 1day and 2 weeks.
General growth parameters including the blood sugar, liver and renal function index before and after the intervention were tested.
Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured before and after the intervention. The three groups were all peripheral blood.
Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. We used the radio-immunoassay method to test the ferritin (DADE BEHRING, Germany), the chemical method to the serum iron and the automatic biochemical analyzer (automatic biochemical analyzer, 7600, HITACH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vifor and EPO | Experimental | Drug: Vifor and EPOintravenous iron and EPO |
| control | Placebo comparator | Other: standard PNno intravenous iron or EPO |
| Vifor | Experimental | Drug: Viforintravenous iton but no EPO |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian
Key exclusion criteria (1 listed)
- Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days
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 |
|---|---|---|
| standard PNAlso: a control groupGroup 1: a control group who received standard PN | Other | control |
| ViforAlso: an iron-supplemented groupiron sucrose, 200 μg/kg per day, was given everyday with PN, | Drug | Vifor |
| Vifor and EPOAlso: iron-supplemented combined EPO groupEPO, 400U/kg, was given twice a week (Monday and Friday). IS, 200 μg/kg per day, was given everyday with PN, and the dose was continued until 2 weeks after birth | Drug | Vifor and EPO |
Primary outcome
Number of participants with Hematological evaluation
Time frame: up to 2 weeks
Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were measured before and after the intervention. The three groups were all peripheral blood.
1 secondary outcome
Iron storage
Time frame: up to 2 weeks
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 25 Feb 2020.
- 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.
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 Phase 4 study testing standard PN, Vifor and Vifor and EPO in people with Malnutrition, run by Kunshan First People's Hospital Affiliated to Jiangsu University 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 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 25 Feb 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of participants with Hematological evaluation (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?
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 25 Feb 2020.