Very Low Birth Weight Infant (<1250g)NCT02137473
Bovine vs. Human Milk-Based Fortifier Study
A study testing Human milk-based fortifier and Bovine protein-based fortifier in people with Very Low Birth Weight Infant (<1250g), run by The Hospital for Sick Children at 18 sites in Canada.
Trial summary
Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome. Read more about this study
- Who is it for?
- Ages Up to 2 weeks
- Conditions the study is for
- Very Low Birth Weight Infant (<1250g)
- What is being tested?
- Human milk-based fortifier and Bovine protein-based fortifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 18 sitesCanada
- Study dates
- Aug 2014to Mar 2016
- 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 Up to 2 weeks
- All sexes
- Child
Who may be able to join
- <1250g birth weight
- Parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient
Who cannot join
- Infant receives formula or a nutrient fortifier prior to randomization
- >day 14 at the time of enrollment and enteral feeds have not commenced
- Infants with major congenital or chromosomal anomalies that could impact growth
- Enrollment in another research study affecting nutritional management during the feeding intervention
- Reasonable potential that the infant will be transferred to a neonatal intensive care unit where the study protocol will not be continued
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Canada18 sites
William Osler Health System-Brampton
Brampton, Ontario, L6R 3J7
William Osler Health System-Etobicoke
Etobicoke, Ontario, M9V 1R8
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, B3K 6R8
Markham Stouffville Hospital
Markham, Ontario, L3P 7P3
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Lakeridge Health
Oshawa, Ontario, L1G 2B9
Mackenzie Health
Richmond Hill, Ontario, L4C 4Z3
Rouge Valley Health System
Toronto, Ontario, M1E 4B9
The Scarborough Hospital-General
Toronto, Ontario, M1P 2V5
The Scarborough Hospital-Birchmount
Toronto, Ontario, M1W 3W3
North York General Hospital
Toronto, Ontario, M2K 1E1
Humber River Hospital
Toronto, Ontario, M3N 1N1
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
St Joseph's Health Centre
Toronto, Ontario, M6R 1B5
About this study
Official title: Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-Bovine vs. Human Milk-Based Fortifier Study
Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome. Adding nutrients to human milk improves their nutritional status and growth, but it is unclear if adding bovine protein-based fortifiers as is the current standard of care has some unintended negative consequences to neonates. Infants will be randomized to have their feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier and will be followed in hospital to assess feeding tolerance, growth, gut inflammation, mother's milk and infant gut microbiome, and neonatal morbidity and mortality.
- Conditions
- Very Low Birth Weight Infant (<1250g)
- Being tested
- Human milk-based fortifier, Bovine protein-based fortifier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milk-based fortifierOther
Bovine protein-based fortifierOther
| Study group | Role | What they receive |
|---|---|---|
| Bovine protein-based fortifier | Active comparator | Not described Receives: Other: Bovine protein-based fortifier |
| Human milk-based fortifier | Experimental | Not described Receives: Other: Human milk-based fortifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding tolerance
Percentage of infants with a significant feeding interruption as defined by days feedings held for ≥12 hours OR feeds reduced by >50% (ml/kg/d) not due to a clinical procedure or transitioning to the breast
Measured: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Secondary outcomes (1)
Growth
Daily weight measurements, weekly length measurements, weekly head circumference measurements, z-scores for anthropometric measures
Measured: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight Infant (<1250g)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah L O'Connor, PhD RD, Principal investigator, The Hospital for Sick Children, University of TorontoSharon L Unger, MD FRCPC, Principal investigator, Mount Sinai Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137473
- Sponsor's protocol ID
- 1000044263
- Status last verified
- Nov 2021
- First submitted
- 6 May 2014
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shama S, Asbury MR, Kiss A, Bando N, Butcher J, Comelli EM, Copeland JK, Greco A, Kothari A, Sherman PM, Stintzi A, Taibi A, Tomlinson C, Unger S, Wang PW; OptiMoM Feeding Group; O'Connor DL. Mother's milk microbiota is associated with the developing gut microbial consortia in very-low-birth-weight infants. Cell Rep Med. 2024 Sep 17;5(9):101729. doi: 10.1016/j.xcrm.2024.101729. Epub 2024 Sep 6.
PubMed 39243753Asbury MR, Shama S, Sa JY, Bando N, Butcher J, Comelli EM, Copeland JK, Forte V, Kiss A, Sherman PM, Stintzi A, Taibi A, Tomlinson C, Unger S, Wang PW, O'Connor DL; OptiMoM Feeding Group. Human milk nutrient fortifiers alter the developing gastrointestinal microbiota of very-low-birth-weight infants. Cell Host Microbe. 2022 Sep 14;30(9):1328-1339.e5. doi: 10.1016/j.chom.2022.07.011. Epub 2022 Aug 19.
PubMed 35987195Hopperton KE, Pitino MA, Walton K, Kiss A, Unger SL, O'Connor DL, Bazinet RP. Docosahexaenoic acid and arachidonic acid levels are correlated in human milk: Implications for new European infant formula regulations. Lipids. 2022 May;57(3):197-202. doi: 10.1002/lipd.12338. Epub 2022 Feb 15.
PubMed 35170053Hopperton KE, Pitino MA, Chouinard-Watkins R, Shama S, Sammut N, Bando N, Williams BA, Walton K, Kiss A, Unger SL, Bazinet RP, O'Connor DL. Determinants of fatty acid content and composition of human milk fed to infants born weighing <1250 g. Am J Clin Nutr. 2021 Oct 4;114(4):1523-1534. doi: 10.1093/ajcn/nqab222.
PubMed 34254983Hopperton KE, O'Connor DL, Bando N, Conway AM, Ng DVY, Kiss A, Jackson J, Ly L; OptiMoM Feeding Group; Unger SL. Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial. Curr Dev Nutr. 2019 Nov 12;3(12):nzz129. doi: 10.1093/cdn/nzz129. eCollection 2019 Dec.
PubMed 32154499O'Connor DL, Kiss A, Tomlinson C, Bando N, Bayliss A, Campbell DM, Daneman A, Francis J, Kotsopoulos K, Shah PS, Vaz S, Williams B, Unger S; OptiMoM Feeding Group. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial. Am J Clin Nutr. 2018 Jul 1;108(1):108-116. doi: 10.1093/ajcn/nqy067.
PubMed 29878061
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-Bovine vs. Human Milk-Based Fortifier Study
- ClinicalTrials.gov ID
- NCT02137473
- Acronym / sponsor ID
- 1000044263
- Conditions
- Very Low Birth Weight Infant (<1250g)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 May 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.
Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome. Adding nutrients to human milk improves their nutritional status and growth, but it is unclear if adding bovine protein-based fortifiers as is the current standard of care has some unintended negative consequences to neonates. Infants will be randomized to have their feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier and will be followed in hospital to assess feeding tolerance, growth, gut inflammation, mother's milk and infant gut microbiome, and neonatal morbidity and mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bovine protein-based fortifier | Active comparator | Other: Bovine protein-based fortifier |
| Human milk-based fortifier | Experimental | Other: Human milk-based fortifier |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- <1250g birth weight
- Parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient
Key exclusion criteria (5 listed)
- Infant receives formula or a nutrient fortifier prior to randomization
- >day 14 at the time of enrollment and enteral feeds have not commenced
- Infants with major congenital or chromosomal anomalies that could impact growth
- Enrollment in another research study affecting nutritional management during the feeding intervention
- Reasonable potential that the infant will be transferred to a neonatal intensive care unit where the study protocol will not be continued
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 |
|---|---|---|
| Human milk-based fortifier | Other | Human milk-based fortifier |
| Bovine protein-based fortifier | Other | Bovine protein-based fortifier |
Primary outcome
Feeding tolerance
Time frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Percentage of infants with a significant feeding interruption as defined by days feedings held for ≥12 hours OR feeds reduced by >50% (ml/kg/d) not due to a clinical procedure or transitioning to the breast
1 secondary outcome
Growth
Time frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
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 26 Nov 2021.
- Derived from this study: PubMed 39243753Shama S, Asbury MR, Kiss A, Bando N, Butcher J, Comelli EM, Copeland JK, Greco A, Kothari A, Sherman PM, Stintzi A, Taibi A, Tomlinson C, Unger S, Wang PW; OptiMoM Feeding Group; O'Connor DL. Mother's milk microbiota is associated with the developing gut microbial consortia in very-low-birth-weight infants. Cell Rep Med. 2024 Sep 17;5(9):101729. doi: 10.1016/j.xcrm.2024.101729. Epub 2024 Sep 6.
- Derived from this study: PubMed 35987195Asbury MR, Shama S, Sa JY, Bando N, Butcher J, Comelli EM, Copeland JK, Forte V, Kiss A, Sherman PM, Stintzi A, Taibi A, Tomlinson C, Unger S, Wang PW, O'Connor DL; OptiMoM Feeding Group. Human milk nutrient fortifiers alter the developing gastrointestinal microbiota of very-low-birth-weight infants. Cell Host Microbe. 2022 Sep 14;30(9):1328-1339.e5. doi: 10.1016/j.chom.2022.07.011. Epub 2022 Aug 19.
- Derived from this study: PubMed 35170053Hopperton KE, Pitino MA, Walton K, Kiss A, Unger SL, O'Connor DL, Bazinet RP. Docosahexaenoic acid and arachidonic acid levels are correlated in human milk: Implications for new European infant formula regulations. Lipids. 2022 May;57(3):197-202. doi: 10.1002/lipd.12338. Epub 2022 Feb 15.
- Derived from this study: PubMed 34254983Hopperton KE, Pitino MA, Chouinard-Watkins R, Shama S, Sammut N, Bando N, Williams BA, Walton K, Kiss A, Unger SL, Bazinet RP, O'Connor DL. Determinants of fatty acid content and composition of human milk fed to infants born weighing <1250 g. Am J Clin Nutr. 2021 Oct 4;114(4):1523-1534. doi: 10.1093/ajcn/nqab222.
- Derived from this study: PubMed 32154499Hopperton KE, O'Connor DL, Bando N, Conway AM, Ng DVY, Kiss A, Jackson J, Ly L; OptiMoM Feeding Group; Unger SL. Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial. Curr Dev Nutr. 2019 Nov 12;3(12):nzz129. doi: 10.1093/cdn/nzz129. eCollection 2019 Dec.
- Derived from this study: PubMed 29878061O'Connor DL, Kiss A, Tomlinson C, Bando N, Bayliss A, Campbell DM, Daneman A, Francis J, Kotsopoulos K, Shah PS, Vaz S, Williams B, Unger S; OptiMoM Feeding Group. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial. Am J Clin Nutr. 2018 Jul 1;108(1):108-116. doi: 10.1093/ajcn/nqy067.
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.
Deborah L O'Connor, PhD RD principal investigator
The Hospital for Sick Children, University of Toronto
Sharon L Unger, MD FRCPC principal investigator
Mount Sinai Hospital, University of Toronto
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human milk-based fortifier and Bovine protein-based fortifier in people with Very Low Birth Weight Infant (<1250g), run by The Hospital for Sick Children at 18 sites in Canada.
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 2 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada. 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?
Feeding tolerance (time frame: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first). 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 NCT02137473, which also lists 6 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 26 Nov 2021.