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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD111018-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mount Sinai Hospital, Canada | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
| University of Toronto | OTHER |
| University of Manitoba |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 18-24 months CA |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 18-24 months CA |
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Inclusion Criteria:
• Secondary data and biospecimens from participants of the MaxiMoM Platform RCTs
Exclusion Criteria:
• Data and biospecimens from infants who are not enrolled in the three trials are eligible for this project.
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Very Low Birth Weight infants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dubraiicka Pichardo, MSc | Contact | 416-813-7654 | 305777 | dubraiicka.pichardo@sickkids.ca |
| Aneta Plaga, BSc | Contact | 416-978-2422 | aneta.plaga@utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Deborah L O'Connor, PhD, RN | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Active, not recruiting | Palo Alto | California | 94304-1212 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29878061 | Background | 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. | |
| 27825008 | Background | O'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. |
| Label | URL |
|---|---|
| MaxiMoM Research Platform | View source |
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Data transfer will take place via Secure File Transfer Protocol (SFTP). Sub-agreements which cover data and sample sharing and confidentiality is in place.
December 2024 to December 2027
During the Opti-NuM project the following institutions will be involved in data and sample analysis as indicated. Data sharing will take place through SFTP, bio specimens will be shipped for analyses.
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| OTHER |
| Stanford University | OTHER |
| University of California, San Diego | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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| 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. | 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. | 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. | 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. | 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. | During hospital stay, an average of 60 days. |
| University of California - San Diego |
| Active, not recruiting |
| San Diego |
| California |
| 92093-0715 |
| United States |
| University of Manitoba | Active, not recruiting | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| The Hospital for Sick Children | Active, not recruiting | Toronto | Ontario | M5G 0A4 | Canada |
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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