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Recruiting NCT06870981

Optimizing Nutrition and Milk (Opti-NuM) Project

— Observational Very Low Birth Weight Baby Early Nutrition and the Preterm Infant Nutritional Requirements Human Milk Fortification

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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..
Who it may be relevant to
Registry conditions: Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification. Basic parameters: 1 Hour — 21 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Improving Growth and Neurodevelopment of Very Low Birth Weight Infants Through Precision Nutrition: The Optimizing Nutrition and Milk (Opti-NuM) Project

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Cognitive composite score on the Bayley Scales of Infant and Toddler Development. [Time frame: At 18-24 months CA]
Secondary outcome measures (6)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 4 centers
  • University of Manitoba — Winnipeg
  • Sunnybrook Health Sciences Centre — Toronto
  • The Hospital for Sick Children — Toronto
  • Mount Sinai Hospital — Toronto
United States · 2 centers
  • Stanford University — Palo Alto
  • University of California - San Diego — San Diego

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. PMID 29878061
  • 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.201 PMID 27825008

Identifiers

NCT: NCT06870981 · 4842 · 5R01HD111018-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗