An observational study in Human Milk Fortification, Very Low Birth Weight Baby and Human Milk Nutrition, sponsored by The Hospital for Sick Children. Completed at 2 sites in 2 countries. Open to participants aged 1 Hour to 21 Days. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by The Hospital for Sick Children · Observational
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm formula is the most appropriate supplement as it has been shown to reduce the risk of necrotizing enterocolitis (NEC).
Most available evidence suggests neither mother's milk nor PDHM will meet the elevated nutritional requirements of VLBW infants without multi-nutrient fortification. Globally, the current standard of care is to use bovine protein-based nutrient fortifiers to meet these elevated nutrient requirements. Given the known benefits of mother's milk, the reduction in the risk of NEC with use of PDHM as a supplement, and the availability of human milk-based multi-nutrient fortifiers (HMBF), there has been considerable interest in the efficacy of HMBF over the less costly bovine milk-based fortifiers (BMBF).
This study is an analysis of individual participant data merged from randomized control trials that examined the efficacy of HMBF compared to BMBF during hospitalization, on the risk of death and severe morbidity or major feeding interruption. Participants of the trials included in the analyses were fed exclusively with human milk or a supplement of pasteurized donor human milk (PDHM).
Only two RCTs met this criteria -OptiMoM and the N-forte trial. In both studies the intervention aligned to commence upon randomization into the HMBF or BMBF groups. The difference between the OptiMoM and N-forte feeding protocols was that the later allowed for individualized fortification based on milk analysis whereas OptiMoM used standard fortification, predominant in Canada and globally.
For OptiMoM, the feeding intervention continued until infants were 84 days of age, discharge, or when the infant consumed ≥2 complete oral feeds daily. For N-forte trial, the feeding intervention ended when babies reached 34 weeks (zero days). Both studies followed participants and continued data collection if transferred to a level II NICU for convalescence (OptiMoM) or home care service followed closely by NICU nurses (N-forte) until discharge.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 355 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants of the OptiMoM and N-Forte trial are VLBW infants fed exclusively Human Milk.
Inclusion Criteria:
Infants born VLBW fed exclusively with Human Milk (parent milk or pasteurized donor milk) fortified with HMBF
Other: No intervention; Observational study
Infants born VLBW fed exclusively with Human Milk (parent milk or pasteurized donor milk) fortified with BMBF
Other: No intervention; Observational study
OptiMoM-NForte is meta-analysis study (observational secondary use of data), the investigators will analyze data from the OptiMoM and NForte trials. No interventions form part of this study.
Number of participants with composite of NEC (NEC II-III), culture-proven late-onset sepsis and mortality.
The first primary outcome is a binary (yes/no) composite of NEC (NEC II-III), culture-proven late-onset sepsis and mortality.
Time frame: From study day 1 through hospitalization, approximately 60 days.
Percentage of infants with an interruption in enteral feeding.
The second primary outcome is the percentage of infants with an interruption in enteral feeding after commencement of the intervention (e.g. Study Day 1), unrelated to a clinical procedure, that lasted for ≥12 h or a \>50% reduction in volume over the same time-frame.
Time frame: Through feeding intervention, approximately 50 days.
Days from birth to full enteral feeding.
Full enteral feeding (defined as 150 ml/kg/d).
Time frame: Approximately 10 days.
Number of participants with NEC II-III.
NEC II-III defined using Bell's staging criteria with Bell Stage \>II classification consisting of clinical symptoms and evidence of septic shock, pneumatosis, bowel perforation, or histologic evidence of bowel ischemia consistent with NEC on bowel resection.
Time frame: From study day 1 through hospitalization, approximately 60 days.
Number of participants with late onset-sepsis.
Late-onset sepsis was defined as clinical symptoms and a positive culture in blood, cerebrospinal fluid, or suprapubic or catheter urine ≥5 days post-partum.
Time frame: From study day 1 through hospitalization, approximately 60 days.
Total deaths prior to discharge.
Total deaths prior to hospital discharge or discharge from home-care in Sweden.
Time frame: From study day 1 through hospitalization, approximately 60 days.
Number of participants with bronchopulmonary dysplasia.
Bronchopulmonary dysplasia defined as a need for oxygen support at 36 weeks 0 days.
Time frame: Assessed at 36 weeks 0 days post-conceptional age.
Number of participants with severe retinopathy of prematurity (ROP).
Severe retinopathy of prematurity (ROP) that was treated (e.g. laser or intraocular antivascular injection).
Time frame: From study day 1 through hospitalization, approximately 60 days.
Cause of death prior to discharge.
Cause of death prior to hospital discharge or discharge from home-care in Sweden (exploratory outcome).
Time frame: From study day 1 through hospitalization, approximately 60 days.
Number of participants with surgical NEC.
NEC requiring surgical intervention (exploratory outcome).
Time frame: From study day 1 through hospitalization, approximately 60 days.
Mortality and morbidity index.
A composite of death, NEC Bell´s II-III, culture-proven sepsis, treated ROP and BPD. (deemed exploratory given a similar composite used as the primary outcome)
Time frame: From study day 1 through hospitalization, approximately 60 days.
Number of withdrawals.
Number of infants withdrawn from the intervention for any reason (exploratory outcome).
Time frame: From study day 1 through hospitalization, approximately 60 days.
Days on parenteral nutrition.
Number of days on parenteral nutrition from birth/from Study Day 1. Defined as receiving amino acids and/or fat intravenously, not just a source of carbohydrate (exploratory outcome).
Time frame: Through feeding intervention, approximately 50 days.
Percentage of enteral feeds fed as mother's versus PDHM.
Exploratory outcome.
Time frame: Through feeding intervention, approximately 50 days.
Plan to share: Yes — Data transfer will take place via Secure File Transfer Protocol (SFTP). A sub-agreement which covers data sharing and confidentiality is in place.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: February 2025 to February 2027
Access criteria: The Hospital for Sick Children (Lead Dr. Deborah L. O'Connor PhD, RD): Data analysis. Umeå University - (Lead Dr. Magnus Domellöf MD, PhD): Data analysis.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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