OptiMoM

Study 1

Kindergarten Follow-Up Study
Study 2
Nutrient Fortifier Study

Study 1 is a prospective follow-up of VLBW infants enrolled in the DoMINO trial designed to evaluate the effectiveness of donor milk compared to preterm formula as a supplement to mother's milk when the latter is unavailable.  Neurodevelopment and body composition will be assessed at Kindergarten age as children enter the school system.  A three group comparison based on how infants were fed during the DoMINO intervention will be done: (1) any donor milk, (2) any preterm formula, (3) exclusively mother's milk.  For future studies, a DNA biorepository will be established.

 

Primary research question: Does use of donor milk compared to preterm formula as a supplement to mother’s milk for 90 days or until hospital discharge, whichever comes first, improve the cognitive development of VLBW infants at 5.5 years of age as assessed using full-scale IQ on the Wechsler Preschool and Primary Scale of Intelligence-IV (WPPSI-IV)?
Secondary research questions: Does use of donor milk compared to preterm formula as a supplement to mother’s milk for 90 days or until hospital discharge, whichever comes first, in VLBW infants: (i) improve other facets of cognitive development assessed using the WPPSI-IV including language development, performance IQ, processing speed; (ii) verbal language skills assessed by the Peabody Picture Vocabulary Test-4; (iii) reduce the likelihood of being overweight/obese; (iv) improve measures of brain structure and function?

Study 2 is a pragmatic multi-centre, double blinded, randomized controlled trial designed to evaluate the effectiveness of adding a human milk-based compared to a bovine protein-based nutrient fortifier to human milk for VLBW infants for 84 days, discharge from hospital or when infants are oral feeding, whichever comes first.  The study population will consist of infants born <1250g enrolled at the following Level III NICUs: Toronto-based Mount Sinai Hospital, The Hospital for Sick Children, and Sunnybrook Health Sciences Centre as well as the IWK Health Centre in Halifax.  For future studies, stool and breastmilk biorepositories will be established. 

 

Primary research question: Does addition of a human milk-based nutrient fortifier compared to a bovine protein-based nutrient fortifier to human milk fed to VLBW infants during initial hospitalization improve feeding tolerance?
Secondary research questions: Does addition of a human milk-based nutrient fortifier compared to a bovine protein-based nutrient fortifier to human milk fed to VLBW infants: (i) support growth, (ii) improve other measures of feeding tolerance, (iii) reduce gut inflammation, (iv) reduce neonatal mortality and morbidity? 

https://clinicaltrials.gov/ct2/show/NCT02137473

Study 3

Protein Study

Optimizing Access to Mother's Milk: Attending to Ethical, Legal and Social Implications (ELSI)

This is a pragmatic multi-centre, double blinded, randomized controlled trial designed to evaluate the effectiveness of adding an extra 1.0g/kg/d protein to the human milk (mother's milk, donor milk) fed to VLBW infants after nutrient fortification has commenced.  The study population will consist of infants born <1500g enrolled at the following Level III NICUs: Toronto-based Mount Sinai Hospital and The Hospital for Sick Children; Hamilton's McMaster Children's Hospital; and Vancouver's BC Children's Hospital.  For future studies, stool, breastmilk and DNA biorepositories will be established.


Primary research question: Does addition of an extra 1.0g/kg/d protein to human milk to target a total protein intake of 4.5 to 5g/kg/d compared to 3.5g/kg/d during initial hospitalization improve the cognitive outcomes of VLBW infants at 24 months corrected age (CA) as assessed using the cognitive composite score on the Bayley Scales of Infant and Toddler Development (BSID-III)?

Secondary research questions: Does addition of an extra 1.0g/kg/d protein to human milk to target a total protein intake of 4.5 to 5g/kg/d compared to 3.5g/kg/d during initial hospitalization of VLBW infants: (i) improve language and motor development composite scores on the BSID-III at 24 months CA; (ii) enhance brain structure, metabolism, and connectivity between cognitive brain processing regions; (iii) promote growth; (iv) increase lean body mass; (v) reduce neonatal mortality and morbidity; (vi) impact feeding tolerance?
 

 

 

Optimizing infant access to mother's milk or donor milk requires both an appreciation of ethical, legal and social issues relevant to milk banks in addition to an appreciation of the perspectives of healthcare providers, potential donors and recipients of donor milk.  While the insights of each of the above groups may be distinct, this project provides a valuable opportunity to determine key ethical values, social values, legal parameters, and concerns of those involved that need to be considered in optimizing milk bank processes.

 

ELSI Study objectives:
1. To identify and examine the ethical and social values embedded in models of donor milk collection, distribution and use.
2. To clarify the legal parameters in models of donor milk collection, distribution and use.
3. To identify the values, consent experiences of healthcare providers, potential donors and potential recipients related to donor milk.
4. To examine whether there are gendered aspects to donation and use of banked milk that may impact women‘s choices.
5. To provide ethically, legally and socially grounded recommendations
, as appropriate, aimed at maximizing human milk donation and ethically indicated use.

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