Ferritin Levels in Very Preterm InfantsNCT06843278

Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

An observational study of Ferritin Levels in Very Preterm Infants, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM). Read more about this study

Who is it for?: Ages 2 to 4 weeks
Conditions the study is for: Ferritin Levels in Very Preterm Infants
What is being tested?: maternal breast milk and Donor breast milk
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 17 Aug 2022to 17 Oct 2024
Phase: Observational
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 2 to 4 weeks
All sexes
No healthy volunteers
Child

Study population: Very preterm infants

Who may be able to join

All preterm infants born between 29 weeks and 0 days -32 weeks and 6 days of gestational age and admitted to the NICU at Advent Health for Children
Received either MBM or DBM starting between 5 to10 days of life
Infants receiving >50% feeding volume by DBM for the first 14 days of life will be considered to have received predominantly DBM. The comparison group will be infants who received > 50% of MBM for the first 14 days of life.
Parent able to read and write in the English language.

Who cannot join

Death prior to completion of participation
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.

United States1 site

AdventHealth
Orlando, Florida, 32803

Other trials in United States

About this study

Official title: Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants: A Prospective, Observational Study

This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).

Conditions: Ferritin Levels in Very Preterm Infants
Being tested: maternal breast milk, Donor breast milk
Keywords: Breast milk, Donor breast milk, Ferritin level, very preterm infants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

maternal breast milkOther
Very preterm infants receiving maternal breast milk
Donor breast milkOther
Very preterm infants receiving donor breast milk

Study groups in NCT06843278
Study group	Role	What they receive
Very preterm infants receiving breast milk		Not described Receives: Other: maternal breast milk
Very preterm infants receiving donor breast milk		Not described Receives: Other: Donor breast milk

What is being measured

The primary outcome is the main question the study is designed to answer.

The Average Serum ferritin level in very preterm infants
The average serum ferritin level (ng/ml) in very preterm infants receiving donor breast milk or maternal breast milk
Measured: Until four weeks of age or discharge

Secondary outcomes (2)

The Average Hemoglobin levels (g/dl) in very preterm infants
The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk
Measured: Until four weeks of age or discharge
The Average Bilirubin Levels (mg/dL) in very preterm infants
The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk
Measured: until four weeks of age or discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 202217 Oct 2024

First posted24 Feb 2025
Study start17 Aug 2022
Primary completion17 Oct 2024
Study completion17 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Ferritin Levels in Very Preterm InfantsStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06843278
Sponsor's protocol ID: 1878559
Status last verified: Jan 2025
First submitted: 20 Feb 2025
Last updated: 24 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gao C, Miller J, Middleton PF, Huang YC, McPhee AJ, Gibson RA. Changes to breast milk fatty acid composition during storage, handling and processing: A systematic review. Prostaglandins Leukot Essent Fatty Acids. 2019 Jul;146:1-10. doi: 10.1016/j.plefa.2019.04.008. Epub 2019 May 1.
PubMed 31186148
Maisels MJ, Gifford K. Breast-feeding, weight loss, and jaundice. J Pediatr. 1983 Jan;102(1):117-8. doi: 10.1016/s0022-3476(83)80305-9. No abstract available.
PubMed 6848709
Joy R, Krishnamurthy S, Bethou A, Rajappa M, Ananthanarayanan PH, Bhat BV. Early versus late enteral prophylactic iron supplementation in preterm very low birth weight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F105-9. doi: 10.1136/archdischild-2013-304650. Epub 2013 Dec 3.
PubMed 24302687
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 28114607
Mercer 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 30473033
German 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 34324880
Taufek NM, Cartwright D, Hewavitharana A, Koorts P, McConachy H, Shaw N, Whitfield K, Davies M. TO INVESTIGATE THE EFFECT OF THE PASTEURISATION PROCESS ON TRACE ELEMENTS IN DONOR BREAST MILK. Arch Dis Child. 2016 Sep;101(9):e2. doi: 10.1136/archdischild-2016-311535.27.
PubMed 27540206
Mohd-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 27253894
Mannel 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 29287170
Stoltz 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 25117506
Hard 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 30565323
Quigley 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 31322731
Arslanoglu 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 20443660
American Academy of Pediatrics Policy Statement. Breastfeeding and the use of breast milk. Pediatrics 2012; 129:e827-841

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants: A Prospective, Observational Study
ClinicalTrials.gov ID: NCT06843278
Acronym / sponsor ID: 1878559
Conditions: Ferritin Levels in Very Preterm Infants
Keywords: Breast milk, Donor breast milk, Ferritin level, very preterm infants
Study type: Observational
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: AdventHealthUniversity, hospital or other
Study start: 17 Aug 2022 (actual)
Primary completion: 17 Oct 2024 (actual)
Study completion: 17 Oct 2024 (actual)
First posted: 24 Feb 2025 (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.

This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Very preterm infants receiving breast milk	–	Other: maternal breast milk
Very preterm infants receiving donor breast milk	–	Other: Donor breast milk

Who may qualify

Ages: 2 to 4 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Very preterm infants

Key inclusion criteria (4 listed)

All preterm infants born between 29 weeks and 0 days -32 weeks and 6 days of gestational age and admitted to the NICU at Advent Health for Children
Received either MBM or DBM starting between 5 to10 days of life
Parent able to read and write in the English language.

Key exclusion criteria (5 listed)

Death prior to completion of participation
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
maternal breast milkVery preterm infants receiving maternal breast milk	Other	Very preterm infants receiving breast milk
Donor breast milkVery preterm infants receiving donor breast milk	Other	Very preterm infants receiving donor breast milk

Primary outcome

The Average Serum ferritin level in very preterm infants
Time frame: Until four weeks of age or discharge
The average serum ferritin level (ng/ml) in very preterm infants receiving donor breast milk or maternal breast milk

2 secondary outcomes

The Average Hemoglobin levels (g/dl) in very preterm infants
Time frame: Until four weeks of age or discharge
The Average Bilirubin Levels (mg/dL) in very preterm infants
Time frame: until four weeks of age or discharge

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 24 Feb 2025.
Background: PubMed 31186148Gao C, Miller J, Middleton PF, Huang YC, McPhee AJ, Gibson RA. Changes to breast milk fatty acid composition during storage, handling and processing: A systematic review. Prostaglandins Leukot Essent Fatty Acids. 2019 Jul;146:1-10. doi: 10.1016/j.plefa.2019.04.008. Epub 2019 May 1.
Background: PubMed 6848709Maisels MJ, Gifford K. Breast-feeding, weight loss, and jaundice. J Pediatr. 1983 Jan;102(1):117-8. doi: 10.1016/s0022-3476(83)80305-9. No abstract available.
Background: PubMed 24302687Joy R, Krishnamurthy S, Bethou A, Rajappa M, Ananthanarayanan PH, Bhat BV. Early versus late enteral prophylactic iron supplementation in preterm very low birth weight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F105-9. doi: 10.1136/archdischild-2013-304650. Epub 2013 Dec 3.
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 27540206Taufek NM, Cartwright D, Hewavitharana A, Koorts P, McConachy H, Shaw N, Whitfield K, Davies M. TO INVESTIGATE THE EFFECT OF THE PASTEURISATION PROCESS ON TRACE ELEMENTS IN DONOR BREAST MILK. Arch Dis Child. 2016 Sep;101(9):e2. doi: 10.1136/archdischild-2016-311535.27.
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.
Individual participant dataSharing planned: No

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.

Anoop Pulickal, MD principal investigator

AdvenHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ferritin Levels in Very Preterm Infants, 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 4 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: finished, as of the sponsor's last update on 24 Feb 2025. 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?

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?

The Average Serum ferritin level in very preterm infants (time frame: Until four weeks of age or discharge). 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 NCT06843278, which also lists 14 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 24 Feb 2025.