Premature BirthBienFERNCT06624709
The Benefit in Terms of Improvement in Haemoglobin Level at 6 Months in Premature Babies Receiving Alternate Iron Substitution 4 Times a Week Compared to a Daily Substitution
A study testing Iron Supplement in people with Premature Birth, run by Riccardo Pfister at 2 sites in Switzerland.
Trial summary
BienFer is a double-blinded randomized controlled trial about iron substitution and abdominal pain. Premature babies and low birth weight babies have lower iron stores than term newborns and are therefore at greater risk of iron deficiency and anemia. Iron deficiency could have consequences for cerebral development. Read more about this study
- Who is it for?
- Ages 14 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Iron Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 2 Nov 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature babies between 28 0/7WA and 34 6/7 WA
- Parental consent, postnatal
- Age of 2 weeks
Who cannot join
- anemia < 80g/l at 2 weeks of age
- Intraventricular Hemorrhage stage III and IV
- Necrotizing Enterocolitis
- Enteral feeding less than 100ml/kg/j after 2 weeks of life
- Congenital disorder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
HUG
Geneva, Canton of Geneva, 1211
Riccardo E Pfister, PhD, +41795534438, riccardo.pfister@hug.ch
Flavia Ferraro, MD, +41795536919, flavia.ferraro@hug.ch
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1011
Anita Truttmann, MD, +41795561012, anita.truttmann@chuv.ch
Flavia Ferraro, MD, +41795536919, flavia.ferraro@hug.ch
About this study
BienFer is a double-blinded randomized controlled trial about iron substitution and abdominal pain. Premature babies and low birth weight babies have lower iron stores than term newborns and are therefore at greater risk of iron deficiency and anemia. Iron deficiency could have consequences for cerebral development. Ferric substitution reduces the risk of iron deficiency and anemia. It is common to replace premature babies with iron substitution between 2 weeks and 6 months of life. In practice, the medical staff notice that newborn with iron substitution have abdominal pain and constipation. A study in the adult population shows that alternate iron supplementation versus daily supplementation improved iron absorption, with no difference in hemoglobin level and decrease abdominal pain. Studies in children shows that intermittent iron supplementation do not change hemoglobin and ferritin level and improve adherence. There is no data comparing daily versus alternate supplementation in premature babies.
The aim of the study is to evaluate if alternate (4 times/week) iron supplementation is equivalent to daily iron substitution for hemoglobin values in premature babies between 28 0/7 weeks amenorrhea (WA) and 34 6/7 WA, and if it reduces abdominal discomfort and inflammation, and if it improves compliance.
- Conditions
- Premature Birth
- Being tested
- Iron Supplement
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron SupplementDrug
The interventional group will receive 2-3mg/kg/day of iron supplementation 4 times per week and the sham comparator will receive 2-3mg/kg/day of iron supplementation 7 times per week
| Study group | Role | What they receive |
|---|---|---|
| Alternate (4 times/week) iron supplementation | Active comparator | This arm will receive 2-3mg/kg/d of maltofer 4 times a day Receives: Drug: Iron Supplement |
| Daily iron substitution | Sham comparator | This arm will receive 2-3mg/kg/d of maltofer 7 times per week. Receives: Drug: Iron Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia at 6 months
Hemoglobin level
Measured: 6 months
Secondary outcomes (20)
Anemia
Hemoglobin
Measured: at 2weeks, 1 month, 2-3 months
Anemia
Hematocrit level
Measured: at 2weeks, 1 month, 2-3 months
Ferritin
Ferritin
Measured: at 2 weeks, 1 month, 2-3 months and 6 months
Ret-Hb level
Ret-Hb level
Measured: at 2 weeks, 1 month, 2-3 months and 6 months
Transfusion
Number of patients needed a transfusion
Measured: at 1 month, 2-3 months and 6 months
Therapeutic level
Number of patients needed to increase the iron substitution to a therapeutic level
Measured: at 1 month, 2-3 months and 6 months
Evaluation of abdominal inflammation
Calprotectin level
Measured: at 2 weeks and 2-3 months
Evaluation of abdominal inflammation
Hepcidin level
Measured: at 2 weeks and 2-3 months
Evaluation of intestinal microbiota
Fecal sequencing
Measured: at 2-3 months
Comorbidities
Number of retinopathy of prematurity (ROP)
Measured: at 6 months
Comorbidities
Number of periventricular leukomalacia (PVL)
Measured: at 6 months
Comorbidities
Number of sepsis
Measured: at 6 months
Comorbidities
Number of intraventricular hemorrhage (IVH)
Measured: at 6 months
Comorbidities
Number of bronchopulmonary dysplasia (BPD)
Measured: at 6 months
Comorbidities
Number of necrotizing enterocolitis (NEC)
Measured: at 6 months
Evaluation of weight gain
Tracking weight in Kilograms
Measured: at 2 weeks, 1 month, 2-3 months and 6 months
Evaluation of height gain
Tracking height in Centimeters
Measured: at 2 weeks, 1 month, 2-3 months and 6 months
Evaluation of the growth's parameter
Tracking head circumference in Centimeters
Measured: at 2 weeks, 1 month, 2-3 months and 6 months
Evaluation of abdominal discomfort
Edin scale (0 (better outcome, no pain)-15 (worse outcome, pain))
Measured: 3 times per week during hospitalization then 1 time per 2 weeks until 6 months
Evaluation of abdominal discomfort
Classify stools with Bristol scale (1 (severe constipation) -7 (severe diarrhea))
Measured: 3 times per day during hospitalization then 1 time per 2 weeks until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start2 Nov 2024
- Primary completion16 Sep 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riccardo Pfister
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Riccardo Pfister, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624709
- Sponsor's protocol ID
- 2021-02374
- Acronym
- BienFER
- Status last verified
- Oct 2024
- First submitted
- 14 Sep 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit in Terms of Improvement in Haemoglobin Level at 6 Months in Premature Babies Receiving Alternate Iron Substitution 4 Times a Week Compared to a Daily Substitution
- ClinicalTrials.gov ID
- NCT06624709
- Acronym / sponsor ID
- BienFER / 2021-02374
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Riccardo PfisterUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Oct 2024 (actual)
- 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.
BienFer is a double-blinded randomized controlled trial about iron substitution and abdominal pain. Premature babies and low birth weight babies have lower iron stores than term newborns and are therefore at greater risk of iron deficiency and anemia. Iron deficiency could have consequences for cerebral development. Ferric substitution reduces the risk of iron deficiency and anemia. It is common to replace premature babies with iron substitution between 2 weeks and 6 months of life. In practice, the medical staff notice that newborn with iron substitution have abdominal pain and constipation. A study in the adult population shows that alternate iron supplementation versus daily supplementation improved iron absorption, with no difference in hemoglobin level and decrease abdominal pain. Studies in children shows that intermittent iron supplementation do not change hemoglobin and ferritin level and improve adherence. There is no data comparing daily versus alternate supplementation in premature babies.
The aim of the study is to evaluate if alternate (4 times/week) iron supplementation is equivalent to daily iron substitution for hemoglobin values in premature babies between 28 0/7 weeks amenorrhea (WA) and 34 6/7 WA, and if it reduces abdominal discomfort and inflammation, and if it improves compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternate (4 times/week) iron supplementation | Active comparator | Drug: Iron SupplementThis arm will receive 2-3mg/kg/d of maltofer 4 times a day |
| Daily iron substitution | Sham comparator | Drug: Iron SupplementThis arm will receive 2-3mg/kg/d of maltofer 7 times per week. |
Who may qualify
- Ages
- 14 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Premature babies between 28 0/7WA and 34 6/7 WA
- Parental consent, postnatal
- Age of 2 weeks
Key exclusion criteria (5 listed)
- anemia < 80g/l at 2 weeks of age
- Intraventricular Hemorrhage stage III and IV
- Necrotizing Enterocolitis
- Enteral feeding less than 100ml/kg/j after 2 weeks of life
- Congenital disorder
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 SupplementThe interventional group will receive 2-3mg/kg/day of iron supplementation 4 times per week and the sham comparator will receive 2-3mg/kg/day of iron supplementation 7 times per week | Drug | Alternate (4 times/week) iron supplementation, Daily iron substitution |
Primary outcome
Anemia at 6 months
Time frame: 6 months
Hemoglobin level
20 secondary outcomes
Anemia
Time frame: at 2weeks, 1 month, 2-3 months
Anemia
Time frame: at 2weeks, 1 month, 2-3 months
Ferritin
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Ret-Hb level
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Transfusion
Time frame: at 1 month, 2-3 months and 6 months
Therapeutic level
Time frame: at 1 month, 2-3 months and 6 months
Evaluation of abdominal inflammation
Time frame: at 2 weeks and 2-3 months
Evaluation of abdominal inflammation
Time frame: at 2 weeks and 2-3 months
Evaluation of intestinal microbiota
Time frame: at 2-3 months
Comorbidities
Time frame: at 6 months
Comorbidities
Time frame: at 6 months
Comorbidities
Time frame: at 6 months
Comorbidities
Time frame: at 6 months
Comorbidities
Time frame: at 6 months
Comorbidities
Time frame: at 6 months
Evaluation of weight gain
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Evaluation of height gain
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Evaluation of the growth's parameter
Time frame: at 2 weeks, 1 month, 2-3 months and 6 months
Evaluation of abdominal discomfort
Time frame: 3 times per week during hospitalization then 1 time per 2 weeks until 6 months
Evaluation of abdominal discomfort
Time frame: 3 times per day during hospitalization then 1 time per 2 weeks until 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Supplement in people with Premature Birth, run by Riccardo Pfister at 2 sites in Switzerland.
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 5 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: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline Ferraz (+41 79 553 84 54, celine.ferraz@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia at 6 months (time frame: 6 months). 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 May 2025.