An interventional study of Individually targeted fortification in Preterm Birth, Breast Milk Expression and Nutrition Disorder, Infant, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 1 Day to 21 Days. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Supportive care
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.
Human milk is the recommended diet for preterm infants and it requires fortification to meet their high nutrient requirements. This study addresses a gap in knowledge about the optimal strategy for human milk fortification in the neonatal intensive care unit (NICU).
Infants will be recruited from a single site (Brigham and Women's Hospital, Boston MA). Eligible infants are NICU inpatients born \<31 weeks' gestation and enrolled within 21 days of birth, whose mothers are providing breast milk. Exclusion criteria include major congenital anomalies, severe fetal growth restriction (weight \<3rd percentile), clinically significant gastrointestinal pathology, triplets or higher order multiples, and expected death or transfer. Infants who require fluid restriction \<140 mL/kg/day will also be excluded.
The study period begins when infants have reached full volume (150-160 mL/kg/day) human milk feedings fortified to 24 kcal per ounce. Participants will be randomized to one of two diet groups; twins will be randomized separately. The study diet will continue until 36 weeks' postmenstrual age or hospital discharge, whichever comes first.
Available maternal milk will be pooled with donor milk (if needed) to reach the total daily fluid volume; this "base" milk will be analyzed with a point-of-care human milk analyzer (Miris, AB). All infants will receive at minimum the standard human milk fortification (multicomponent fortifier to 24 kcal/oz plus liquid protein 0.27 g/dL). In one group (control), we will follow the standard of care for milk fortification, only adding more protein and/or energy if weight gain is lagging. In the other group (intervention), we will individually target fortification with additional protein and/or energy so that the "base" milk always contains protein 1 g/dL and energy 67 kcal/dL.
Outcome measures will include physical growth during the diet intervention period, including gain in weight, length, and head circumference and body composition with air displacement plethysmography at the end of the diet intervention. At term equivalent age, participants will undergo brain magnetic resonance imaging. At 2 years corrected age, outcomes include standard and novel neurodevelopmental tests including the Bayley-III and tests of emerging executive function; and physical size.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 130 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care fortification with multicomponent human milk fortifier (24 kcal/oz) and liquid protein (0.27 g/dL); additional protein and/or calories added only for growth faltering.
Standard of care fortification plus extra protein and/or calories to ensure that "base" milk has protein 1 g/dL and calories 67/dL.
Other: Individually targeted fortification
Abbott liquid protein and/or medium chain triglyceride are added routinely to ensure that the "base" milk has protein 1 g/dL and calories 67/dL.
Weight
Weight z-score
Time frame: at study endpoint (36 weeks' postmenstrual age or discharge)
Length
Length z-score
Time frame: at study endpoint (36 weeks' postmenstrual age or discharge)
Fat free mass
Fat free mass estimated with air displacement plethysmography (z-score)
Time frame: at study endpoint (36 weeks' postmenstrual age or discharge)
Total brain volume
Total brain volume by MRI
Time frame: at term equivalent age (38 to 41 weeks' postmenstrual age)
Cerebellar volume
Cerebellar volume by MRI
Time frame: at term equivalent age (38 to 41 weeks' postmenstrual age)
Bayley-III cognitive score
Scaled composite score (continuous), higher score indicates better performance, range of possible scores 55-145
Time frame: at 2 years' corrected age
Bayley-III motor score
Scaled composite score (continuous), higher score indicates better performance, range of possible scores 46-154
Time frame: at 2 years' corrected age
Fat mass
Fat mass estimated with air displacement plethysmography (z-score)
Time frame: at study endpoint (36 weeks' postmenstrual age or discharge)
Weight
Weight z-score
Time frame: at 2 years' corrected age
Height
Height z-score
Time frame: at 2 years' corrected age
Low Bayley-III cognitive score
Scaled composite score \<85 (\>1 standard deviation below the normative mean)
Time frame: At 2 years' corrected age
Low Bayley-III motor score
Scaled composite score \<85 (\>1 standard deviation below the normative mean)
Time frame: At 2 years' corrected age
Bayley-III language score
Scaled composite score (continuous), higher score indicates better performance, range of possible scores 46-154
Time frame: At 2 years' corrected age
Bayley-III language score
Scaled composite score \<85 (\>1 standard deviation below the normative mean)
Time frame: At 2 years' corrected age
Spacial working memory
Spin the Pots task (number of trials, search time)
Time frame: at 2 years' corrected age
Behavioral inhibition
Mommies and Babies task (number of trials, errors)
Time frame: at 2 years' corrected age
Executive function
Behavioral Rating Inventory of Executive Function - Preschool Version, higher scores indicate more problems
Time frame: at 2 years' corrected age
Behavioral difficulties
Infant-Toddler Symptom Checklist - Long Version, higher scores indicate more problems
Time frame: at 2 years' corrected age
Plan to share: No — No current plans to share individual patient data. Future data sharing would involve de-identified data only and would require a data use agreement in accordance with hospital policy.
Started Jan 2020 (actual). Primary completion is estimated for Aug 2027, 91 months after the start.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 91 months is above that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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