Very Low Birth Weight BabyOpti-NuMNCT06870981
Optimizing Nutrition and Milk (Opti-NuM) Project
An observational study of Very Low Birth Weight Baby and Early Nutrition and the Preterm Infant, run by The Hospital for Sick Children at 6 sites in 2 countries.
Trial summary
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. Read more about this study
- Who is it for?
- Ages 1 hour to 21 days
- Conditions the study is for
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements
- How many people
- 1,100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Oct 2010to Dec 2027
- Phase
- Observational
- 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 1 hour to 21 days
- All sexes
- No healthy volunteers
- Child
Study population: Very Low Birth Weight infants
Who may be able to join
- Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs
Who cannot join
- Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Canada4 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Eugene Ng, MD, FRCPC, 416-480-6100 ext. 87781, eugene.ng@sunnybrook.ca
Dubraiicka Pichardo, MSc, 416-813-7654 ext. 305777, dubraiicka.pichardo@sickkids.ca
- Active, not recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 0A4
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Sharon L Unger, MD, 416-586-8593, Sharon.Unger@sinaihealth.ca
Dubraiicka Pichardo, MSc, 4168137654 ext. 305777, dubraiicka.pichardo@sickkids.ca
- Active, not recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 3P4
United States2 sites
- Active, not recruiting
Stanford University
Palo Alto, California, 94304-1212
- Active, not recruiting
University of California - San Diego
San Diego, California, 92093-0715
About this study
Official title: Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in "precision nutrition" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project.
The Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute "as a whole" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour).
Read the detailed description
Observational study mode:
The Opti-NuM Project is a retrospective secondary data/sample use study.
Time perspective:
Secondary use data and biospecimens accruing from the 2 completed studies DoMINO and OptiMOM (NCT02137473) and 1 ongoing RCT MaxiMoM (NCT05308134) are included in this project.
Sampling method:
This project is a secondary use of data/samples, from a cohort consisting of participants of the MaxiMoM Platform RCTs.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification, Human Milk Microbiome, Human Milk Feeding
- Being tested
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Keywords
- Very Low Birth Weight Infants, Early nutrition and the preterm infant, Human milk feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.Other
| Study group | Role | What they receive |
|---|---|---|
| Participants of the MaxiMoM Platform Trials | Secondary data use and biospecimens from participants of the MaxiMoM Platform Trials are infants born 1500g or less (infant weight), born in the Greater Toronto Area. Receives: Other: Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive composite score on the Bayley Scales of Infant and Toddler Development.
Our primary outcome is the cognitive composite score on the Bayley Scales of Infant and Toddler Development collected from the medical record or by home-visit by our research staff. The Bayley is the most widely used instrument globally by clinicians and researchers to assess developmental functioning of infants, toddlers and young children across cognitive, language (receptive, expressive) and motor (fine, gross) domains. Cognitive, language and motor composite scores will be standardized to a mean of 100 with a standard deviation of 15.
The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.
Measured: At 18-24 months CA
Secondary outcomes (6)
Language composite score from the Bayley Scales of Infant and Toddler Development
Language composite score from the Bayley Scales of Infant and Toddler Development. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.
Measured: At 18-24 months CA
Motor composite score from the Bayley Scales of Infant and Toddler Development
Motor composite score from the Bayley Scales of Infant and Toddler Development. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.
Measured: At 18-24 months CA
Weight (g)
Weight gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Daily weights are prospectively extracted from medical records.
Measured: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Length (cm)
Length gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Weekly length is determined by research staff using length boards and standardized procedures.
Measured: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Head circumference (cm)
Head circumference (HC) gains serve as early indicators of the effectiveness of early nutrition and are on the causal pathway to neurodevelopment. Weekly HC measurements are determined by research staff using non-stretchable tape measures and standardized procedures.
Measured: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Serious morbidities
Serious morbidities including late-onset sepsis (>day 5, positive blood or cerebrospinal fluid culture), NEC (Bell stage ≥II), chronic lung disease (respiratory support at 36 weeks) and retinopathy of prematurity requiring treatment are collected prospectively from the medical chart.
Measured: During hospital stay, an average of 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Oct 2010
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight BabyStudies 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
- Retrospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Sunnybrook Health Sciences Centre, University of Toronto, University of Manitoba, Stanford University, University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah L O'Connor, PhD, RN, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870981
- Sponsor's protocol ID
- 4842
- Other IDs
- 5R01HD111018-03
- Acronym
- Opti-NuM
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data transfer will take place via Secure File Transfer Protocol (SFTP). Sub-agreements which cover data and sample sharing and confidentiality is in place.
Publications
O'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 29878061O'Connor DL, Gibbins S, Kiss A, Bando N, Brennan-Donnan J, Ng E, Campbell DM, Vaz S, Fusch C, Asztalos E, Church P, Kelly E, Ly L, Daneman A, Unger S; GTA DoMINO Feeding Group. Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1897-1905. doi: 10.1001/jama.2016.16144.
PubMed 27825008
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project
- ClinicalTrials.gov ID
- NCT06870981
- Acronym / sponsor ID
- Opti-NuM / 4842
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification, Human Milk Microbiome, Human Milk Feeding
- Keywords
- Very Low Birth Weight Infants, Early nutrition and the preterm infant, Human milk feeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Sunnybrook Health Sciences Centre, University of Toronto, University of Manitoba, Stanford University, University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Mar 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.
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants. There is increasing interest in "precision nutrition" approaches, but it is unclear which Human Milk (HM) components require personalized adjustment of doses. Previous efforts have focused on macronutrients, but HM also contains essential micronutrients as well as non-nutrient bioactive components that shape the gut microbiome. Further, it is unclear if or how parental factors (e.g. body mass index, diet) and infant factors (e.g. genetics, gut microbiota, sex, acuity) influence relationships between early nutrition and growth, neurodevelopment and morbidity. Understanding these complex relationships is paramount to developing effective personalized HM feeding strategies for VLBW infants. This is the overarching goal of the proposed Optimizing Nutrition and Milk (Opti-NuM) Project.
The Opti-NuM Project brings together two established research platforms with complementary expertise and resources: 1) the MaxiMoM Program* with its clinically embedded translational neonatal feeding trial network in Toronto (Dr. Deborah O'Connor, Dr. Sharon Unger) and 2) the International Milk Composition (IMiC) Consortium, a world-renowned multidisciplinary network of HM researchers and data scientists collaborating to understand how the myriad of HM components contribute "as a whole" to infant growth and development, using systems biology and machine learning approaches. Members of the IMiC Corsortium that will work with on this study are located at the University of Manitoba (Dr. Meghan Azad), University of California (Dr. Lars Bode) and Stanford (Dr. Nima Aghaeepour).
Detailed description
Observational study mode:
The Opti-NuM Project is a retrospective secondary data/sample use study.
Time perspective:
Secondary use data and biospecimens accruing from the 2 completed studies DoMINO and OptiMOM (NCT02137473) and 1 ongoing RCT MaxiMoM (NCT05308134) are included in this project.
Sampling method:
This project is a secondary use of data/samples, from a cohort consisting of participants of the MaxiMoM Platform RCTs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants of the MaxiMoM Platform Trials | – | Other: Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.Secondary data use and biospecimens from participants of the MaxiMoM Platform Trials are infants born 1500g or less (infant weight), born in the Greater Toronto Area. |
Who may qualify
- Ages
- 1 hour to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very Low Birth Weight infants
Key inclusion criteria (1 listed)
- Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs
Key exclusion criteria (1 listed)
- Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.
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 |
|---|---|---|
| Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study. | Other | Participants of the MaxiMoM Platform Trials |
Primary outcome
Cognitive composite score on the Bayley Scales of Infant and Toddler Development.
Time frame: At 18-24 months CA
Our primary outcome is the cognitive composite score on the Bayley Scales of Infant and Toddler Development collected from the medical record or by home-visit by our research staff. The Bayley is the most widely used instrument globally by clinicians and researchers to assess developmental functioning of infants, toddlers and young children across cognitive, language (receptive, expressive) and motor (fine, gross) domains. Cognitive, language and motor composite scores will be standardized to a mean of 100 with a standard deviation of 15. The range on the composite Bayle Scores is from less than 0.1 to more than 99.9 percentile. A score lower than the 10th percentile indicates developmental delay.
6 secondary outcomes
Language composite score from the Bayley Scales of Infant and Toddler Development
Time frame: At 18-24 months CA
Motor composite score from the Bayley Scales of Infant and Toddler Development
Time frame: At 18-24 months CA
Weight (g)
Time frame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Length (cm)
Time frame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Head circumference (cm)
Time frame: Initial hospitalization, approximately 50 days; at 4 months and 18-24 months CA clinic visit.
Serious morbidities
Time frame: During hospital stay, an average of 60 days.
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 Mar 2025.
- Background: 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.
- Background: PubMed 27825008O'Connor DL, Gibbins S, Kiss A, Bando N, Brennan-Donnan J, Ng E, Campbell DM, Vaz S, Fusch C, Asztalos E, Church P, Kelly E, Ly L, Daneman A, Unger S; GTA DoMINO Feeding Group. Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1897-1905. doi: 10.1001/jama.2016.16144.
- MaxiMoM Research PlatformLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data transfer will take place via Secure File Transfer Protocol (SFTP). Sub-agreements which cover data and sample sharing and confidentiality is in place.
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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.
Deborah L O'Connor, PhD, RN principal investigator
The Hospital for Sick Children
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birth Weight Baby and Early Nutrition and the Preterm Infant, run by The Hospital for Sick Children at 6 sites in 2 countries.
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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, 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 Dubraiicka Pichardo, MSc (416-813-7654 ext. 305777, dubraiicka.pichardo@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive composite score on the Bayley Scales of Infant and Toddler Development. (time frame: At 18-24 months CA). 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 NCT06870981, which also lists 2 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 Mar 2025.