Iron Deficiency AnemiaNCT07816601
Donor Breast Milk 2
A study testing Ferrous Sulfate Oral Product in people with Iron Deficiency Anemia, run by AdventHealth at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol . Read more about this study
- Who is it for?
- Ages 29 to 33 weeks
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferrous Sulfate Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to Dec 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 29 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. All preterm infants born between 29.0-32.6 weeks of gestational age and admitted to the NICU at Advent Health for Children 2. Infants likely to be receiving DBM between 5 to 14 days of life 3. Infants receiving >50% of the feeding volume by DBM will be considered to have received DBM.
Who cannot join
- Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study
- Blood transfusion as determined by clinical team during the study
- Major congenital anomaly or genetic syndrome and major surgical GI conditions that preclude feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
About this study
Official title: Early Iron Supplementation in Very Preterm Infants Fed Donor Breast Milk: A Prospective, Interventional, Clinical Trial
The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol . The main questions it aims to answer are: Does earlier iron supplementation provide increased ferritin levels at 14 and 28 days of life in subjects fed primarily donor breast milk?
Iron supplementation will be implemented when the infant achieves 80ml/kg/day of enteral feeds, as contrasted to the current protocol of full feeds (140 to 160ml/kg/day), the latter usually by Day 14 of life.
At day of life(DOL) 14 (± 4 days), a blood sample will be obtained for serum ferritin determination. Similarly, a second blood draw would be performed at day of life 28 (± 4 days) or prior to discharge, whichever comes earlier
Read the detailed description
In preterm and low birth weight (LBW) infants, moderate-certainty evidence indicates that feeding with commercial infant formula compared with donor breast milk (DBM), either as a supplement to maternal expressed breast milk (MBM) or as a sole diet, results in higher rates of weight gain, linear growth, and head growth but is associated with a higher risk of developing necrotizing enterocolitis (NEC)1-5. Despite the decreased incidence of NEC, DBM has been shown to be inferior to MBM in terms of overall growth. This is attributed to the fact that DBM contains significantly less protein, fat and energy than the milk provided by the mothers of preterm infants. Hence, it is considered standard of care to supplement MBM and DBM with commercial fortifiers.
Yet, considering the extraordinarily high morbidity and mortality, along with the significant economic burden, associated with NEC, the current standard of care is to provide DBM, initially unfortified and subsequently fortified, in lieu of formula in cases where MBM is unavailable or contraindicated. Such DBM, provided by local milk banks are pasteurized prior to shipment, according to standard protocols. Evidence exists for significantly lower iron content in post-pasteurized DBM as compared to pre-pasteurized DBM.
Results from a prospective observation clinical study in 2024 at Advent Health for Children in 34 very preterm infants randomized to receive either DBM or MBM and adjusted for duration of cord clamping, fortification progression and iron supplementation practice, demonstrate that very preterm infants fed DBM have a significantly lower ferritin level at 2 weeks (178.47 vs. 230.06 ng/ml, p=0.04) and hematocrit at 4 weeks (27.41 vs. 32.05%, p= 0.03) (Pulickal et. al. PAS 2025) These reduced levels of serum ferritin and hematocrit levels in DBM fed infants would be important as evidence suggests that iron levels have a correlation with neurodevelopmental outcome. A post-hoc analysis of 692 infants enrolled in the PENUT study of the NRN of the NICHD demonstrated a positive association between iron dose at 60 days and cognitive outcomes at 2 years 9. Similarly, data from a single center tertiary center showed that delayed cord clamping in term infants was associated with higher ferritin levels and greater brain myelination at 4 months of age 10. This was further supported in a study of 540 preterm and term infants in Nepal that showed delayed cord clamping increased ferritin levels and decreased the incidence of anemia at 8 months and 12 months 11.
An opportunity exists for appropriate clinical intervention with earlier iron supplementation based on the results of our study. Optimizing the timing of iron supplementation in DBM fed infants could attenuate the differences in hematological parameters and possibly contribute to improved neuro-developmental outcome by avoiding iron deficiency at a critical stage of infants' neurodevelopment.
The investigational component of this research is: Iron supplementation ( Ferrous sulfate, 2-4 mg/kg/day depending on the infant's body weight) will be implemented early ( approximately 4-6 days of life) when the infant achieves 80ml/kg/day of enteral feeds, as contrasted to the current protocol of full feeds (140 to 160ml/kg/day), the latter usually by Day 14 of life. At DOL 14 (± 4 days), a blood sample (0.5 mL) will be obtained for serum ferritin and hematocrit determination. Similarly, a second blood draw would be performed at DOL 28 (± 4 days) or prior to discharge, whichever comes earlier, for serum ferritin and hematocrit determination. These samples will be obtained from routine clinical blood draws thus minimizing pain and discomfort. The hematocrit may be part of standard clinical care involving routine weekly monitoring.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferrous Sulfate Oral Product
- Keywords
- preterm infant, neonate, ferritin, iron supplementation, donor breast milk, maternal breast milk, low birth weight
- Medical subject headings
- Anemia, Iron-Deficiency, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous Sulfate Oral ProductDrug
Dietary Supplement
| Study group | Role | What they receive |
|---|---|---|
| Very preterm infants | Experimental | Not described Receives: Drug: Ferrous Sulfate Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.
Measured: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)
To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol
To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol
Measured: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start6 May 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816601
- Sponsor's protocol ID
- 2372858
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.
PubMed 28114607Mercer JS, Erickson-Owens DA, Deoni SCL, Dean DC 3rd, Collins J, Parker AB, Wang M, Joelson S, Mercer EN, Padbury JF. Effects of Delayed Cord Clamping on 4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment: A Randomized Controlled Trial. J Pediatr. 2018 Dec;203:266-272.e2. doi: 10.1016/j.jpeds.2018.06.006. Epub 2018 Jul 6.
PubMed 30473033German KR, Vu PT, Comstock BA, Ohls RK, Heagerty PJ, Mayock DE, Georgieff M, Rao R, Juul SE; PENUT Consortium. Enteral Iron Supplementation in Infants Born Extremely Preterm and its Positive Correlation with Neurodevelopment; Post Hoc Analysis of the Preterm Erythropoietin Neuroprotection Trial Randomized Controlled Trial. J Pediatr. 2021 Nov;238:102-109.e8. doi: 10.1016/j.jpeds.2021.07.019. Epub 2021 Jul 27.
PubMed 34324880Mohd-Taufek N, Cartwright D, Davies M, Hewavitharana AK, Koorts P, McConachy H, Shaw PN, Sumner R, Whitfield K. The effect of pasteurization on trace elements in donor breast milk. J Perinatol. 2016 Oct;36(10):897-900. doi: 10.1038/jp.2016.88. Epub 2016 Jun 2.
PubMed 27253894Mannel R, Peck JD. Outcomes Associated With Type of Milk Supplementation Among Late Preterm Infants. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):571-582. doi: 10.1016/j.jogn.2017.11.005. Epub 2017 Dec 27.
PubMed 29287170Stoltz Sjostrom E, Ohlund I, Tornevi A, Domellof M. Intake and macronutrient content of human milk given to extremely preterm infants. J Hum Lact. 2014 Nov;30(4):442-9. doi: 10.1177/0890334414546354. Epub 2014 Aug 12.
PubMed 25117506Hard AL, Nilsson AK, Lund AM, Hansen-Pupp I, Smith LEH, Hellstrom A. Review shows that donor milk does not promote the growth and development of preterm infants as well as maternal milk. Acta Paediatr. 2019 Jun;108(6):998-1007. doi: 10.1111/apa.14702. Epub 2019 Jan 25.
PubMed 30565323Quigley M, Embleton ND, McGuire W. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database Syst Rev. 2019 Jul 19;7(7):CD002971. doi: 10.1002/14651858.CD002971.pub5.
PubMed 31322731Arslanoglu S, Ziegler EE, Moro GE; World Association of Perinatal Medicine Working Group On Nutrition. Donor human milk in preterm infant feeding: evidence and recommendations. J Perinat Med. 2010 Jul;38(4):347-51. doi: 10.1515/jpm.2010.064.
PubMed 20443660Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
PubMed 22371471
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Iron Supplementation in Very Preterm Infants Fed Donor Breast Milk: A Prospective, Interventional, Clinical Trial
- ClinicalTrials.gov ID
- NCT07816601
- Acronym / sponsor ID
- 2372858
- Conditions
- Iron Deficiency Anemia
- Keywords
- preterm infant, neonate, ferritin, iron supplementation, donor breast milk, maternal breast milk, low birth weight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Sep 2026 (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.
The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol . The main questions it aims to answer are: Does earlier iron supplementation provide increased ferritin levels at 14 and 28 days of life in subjects fed primarily donor breast milk?
Iron supplementation will be implemented when the infant achieves 80ml/kg/day of enteral feeds, as contrasted to the current protocol of full feeds (140 to 160ml/kg/day), the latter usually by Day 14 of life.
At day of life(DOL) 14 (± 4 days), a blood sample will be obtained for serum ferritin determination. Similarly, a second blood draw would be performed at day of life 28 (± 4 days) or prior to discharge, whichever comes earlier
Detailed description
In preterm and low birth weight (LBW) infants, moderate-certainty evidence indicates that feeding with commercial infant formula compared with donor breast milk (DBM), either as a supplement to maternal expressed breast milk (MBM) or as a sole diet, results in higher rates of weight gain, linear growth, and head growth but is associated with a higher risk of developing necrotizing enterocolitis (NEC)1-5. Despite the decreased incidence of NEC, DBM has been shown to be inferior to MBM in terms of overall growth. This is attributed to the fact that DBM contains significantly less protein, fat and energy than the milk provided by the mothers of preterm infants. Hence, it is considered standard of care to supplement MBM and DBM with commercial fortifiers.
Yet, considering the extraordinarily high morbidity and mortality, along with the significant economic burden, associated with NEC, the current standard of care is to provide DBM, initially unfortified and subsequently fortified, in lieu of formula in cases where MBM is unavailable or contraindicated. Such DBM, provided by local milk banks are pasteurized prior to shipment, according to standard protocols. Evidence exists for significantly lower iron content in post-pasteurized DBM as compared to pre-pasteurized DBM.
Results from a prospective observation clinical study in 2024 at Advent Health for Children in 34 very preterm infants randomized to receive either DBM or MBM and adjusted for duration of cord clamping, fortification progression and iron supplementation practice, demonstrate that very preterm infants fed DBM have a significantly lower ferritin level at 2 weeks (178.47 vs. 230.06 ng/ml, p=0.04) and hematocrit at 4 weeks (27.41 vs. 32.05%, p= 0.03) (Pulickal et. al. PAS 2025) These reduced levels of serum ferritin and hematocrit levels in DBM fed infants would be important as evidence suggests that iron levels have a correlation with neurodevelopmental outcome. A post-hoc analysis of 692 infants enrolled in the PENUT study of the NRN of the NICHD demonstrated a positive association between iron dose at 60 days and cognitive outcomes at 2 years 9. Similarly, data from a single center tertiary center showed that delayed cord clamping in term infants was associated with higher ferritin levels and greater brain myelination at 4 months of age 10. This was further supported in a study of 540 preterm and term infants in Nepal that showed delayed cord clamping increased ferritin levels and decreased the incidence of anemia at 8 months and 12 months 11.
An opportunity exists for appropriate clinical intervention with earlier iron supplementation based on the results of our study. Optimizing the timing of iron supplementation in DBM fed infants could attenuate the differences in hematological parameters and possibly contribute to improved neuro-developmental outcome by avoiding iron deficiency at a critical stage of infants' neurodevelopment.
The investigational component of this research is: Iron supplementation ( Ferrous sulfate, 2-4 mg/kg/day depending on the infant's body weight) will be implemented early ( approximately 4-6 days of life) when the infant achieves 80ml/kg/day of enteral feeds, as contrasted to the current protocol of full feeds (140 to 160ml/kg/day), the latter usually by Day 14 of life. At DOL 14 (± 4 days), a blood sample (0.5 mL) will be obtained for serum ferritin and hematocrit determination. Similarly, a second blood draw would be performed at DOL 28 (± 4 days) or prior to discharge, whichever comes earlier, for serum ferritin and hematocrit determination. These samples will be obtained from routine clinical blood draws thus minimizing pain and discomfort. The hematocrit may be part of standard clinical care involving routine weekly monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very preterm infants | Experimental | Drug: Ferrous Sulfate Oral Product |
Who may qualify
- Ages
- 29 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. All preterm infants born between 29.0-32.6 weeks of gestational age and admitted to the NICU at Advent Health for Children 2. Infants likely to be receiving DBM between 5 to 14 days of life 3. Infants receiving >50% of the feeding volume by DBM will be considered to have received DBM.
Key exclusion criteria (3 listed)
- Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study
- Blood transfusion as determined by clinical team during the study
- Major congenital anomaly or genetic syndrome and major surgical GI conditions that preclude feeding
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 |
|---|---|---|
| Ferrous Sulfate Oral ProductDietary Supplement | Drug | Very preterm infants |
Primary outcome
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.
Time frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol.
To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol
Time frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)
To determine the hematocrit level(%) in very preterm infants receiving DBM with an early iron supplementation protocol
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 11 Sep 2026.
- Background: PubMed 28114607Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.
- Background: PubMed 30473033Mercer JS, Erickson-Owens DA, Deoni SCL, Dean DC 3rd, Collins J, Parker AB, Wang M, Joelson S, Mercer EN, Padbury JF. Effects of Delayed Cord Clamping on 4-Month Ferritin Levels, Brain Myelin Content, and Neurodevelopment: A Randomized Controlled Trial. J Pediatr. 2018 Dec;203:266-272.e2. doi: 10.1016/j.jpeds.2018.06.006. Epub 2018 Jul 6.
- Background: PubMed 34324880German KR, Vu PT, Comstock BA, Ohls RK, Heagerty PJ, Mayock DE, Georgieff M, Rao R, Juul SE; PENUT Consortium. Enteral Iron Supplementation in Infants Born Extremely Preterm and its Positive Correlation with Neurodevelopment; Post Hoc Analysis of the Preterm Erythropoietin Neuroprotection Trial Randomized Controlled Trial. J Pediatr. 2021 Nov;238:102-109.e8. doi: 10.1016/j.jpeds.2021.07.019. Epub 2021 Jul 27.
- Background: PubMed 27253894Mohd-Taufek N, Cartwright D, Davies M, Hewavitharana AK, Koorts P, McConachy H, Shaw PN, Sumner R, Whitfield K. The effect of pasteurization on trace elements in donor breast milk. J Perinatol. 2016 Oct;36(10):897-900. doi: 10.1038/jp.2016.88. Epub 2016 Jun 2.
- Background: PubMed 29287170Mannel R, Peck JD. Outcomes Associated With Type of Milk Supplementation Among Late Preterm Infants. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):571-582. doi: 10.1016/j.jogn.2017.11.005. Epub 2017 Dec 27.
- Background: PubMed 25117506Stoltz Sjostrom E, Ohlund I, Tornevi A, Domellof M. Intake and macronutrient content of human milk given to extremely preterm infants. J Hum Lact. 2014 Nov;30(4):442-9. doi: 10.1177/0890334414546354. Epub 2014 Aug 12.
- Background: PubMed 30565323Hard AL, Nilsson AK, Lund AM, Hansen-Pupp I, Smith LEH, Hellstrom A. Review shows that donor milk does not promote the growth and development of preterm infants as well as maternal milk. Acta Paediatr. 2019 Jun;108(6):998-1007. doi: 10.1111/apa.14702. Epub 2019 Jan 25.
- Background: PubMed 31322731Quigley M, Embleton ND, McGuire W. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database Syst Rev. 2019 Jul 19;7(7):CD002971. doi: 10.1002/14651858.CD002971.pub5.
- Background: PubMed 20443660Arslanoglu S, Ziegler EE, Moro GE; World Association of Perinatal Medicine Working Group On Nutrition. Donor human milk in preterm infant feeding: evidence and recommendations. J Perinat Med. 2010 Jul;38(4):347-51. doi: 10.1515/jpm.2010.064.
- Background: PubMed 22371471Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate Oral Product in people with Iron Deficiency Anemia, run by AdventHealth at 1 site in United States.
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 3 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 11 Sep 2026. 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 United States. 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?
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 Anoop Pulickal, MD, PhD (407-303-2528, Anoop.Pulickal.MD@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol. (time frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days)). 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 NCT07816601, which also lists 10 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 11 Sep 2026.