| Primary | Fat-free Mass(FFM)-For-age Z-score | Estimated by air displacement plethysmography. FFM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined. | | Posted | | Mean | Standard Deviation | Z-score | | 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer | | | | ID | Title | Description |
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| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.7± 1.4
- OG001-1.6± 1.5
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|
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| Secondary | Fat Mass(FM)-For-age Z-score | Estimated by air displacement plethysmography. FM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined. | | Posted | | Mean | Standard Deviation | Z-score | | 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Body Fat(BF)-For-age Z-score | Body fat estimated by air displacement plethysmography. BF measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined. | | Posted | | Mean | Standard Deviation | Z-score | | 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Anthropometric Measurements | Weight, length, and head circumference measurements. Measurements were converted into Z-scores based on Fenton growth curves (2013). They were calculated at birth and at 36 weeks. This outcome represents the change in weight, length, and head circumference Z-score during the course of the study (i.e., the Z-score at birth was subtracted from the Z-score at 36 weeks). A value of 0 represents that the infant's Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's Z-score during the study; negative values indicate the decrease in the infant's Z-score during the study. | | Posted | | Mean | Standard Deviation | Z-score | | Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first) | | | | ID | Title | Description |
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| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Growth Rate | | | Posted | | Mean | Standard Deviation | g/kg/day | | Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first) | | | | ID | Title | Description |
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| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Number of Participants With Postnatal Growth Failure | Diagnosis of growth failure (weight < 10th percentile using the 2013 Fenton growth curves) | | Posted | | Count of Participants | | Participants | | 36 weeks or hospital discharge (whichever occurred first) | | | | ID | Title | Description |
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| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Number of Participants With Diagnosis of Necrotizing Enterocolitis | Diagnosis of necrotizing enterocolitis stage 2 or 3 | | Posted | | Count of Participants | | Participants | | From birth up to 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Number of Participants With Diagnosis of Intestinal Perforation | Diagnosis of intestinal perforation | | Posted | | Count of Participants | | Participants | | From birth up to 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Death | Death prior to 121 days of life | | Posted | | Count of Participants | | Participants | | Birth to 120 days | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Culture-proven Sepsis | Diagnosis of sepsis with positive blood cultures | | Posted | | Count of Participants | | Participants | | Birth to 120 days | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Number of Days Alive and Receiving Full Enteral Feeding | Time to full enteral feeding days | | Posted | | Median | Inter-Quartile Range | days | | Birth to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Number of Episodes of Feeding Intolerance | Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination | | Posted | | Count of Participants | | Participants | | Birth to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Duration of Hospital Stay in Days | From day of admission to day of hospital discharge to home | | Posted | | Median | Inter-Quartile Range | days | | Birth to 120 days or discharge, whichever occurs first | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Secondary | Serum BUN | Highest serum BUN value in the first 28 days after birth | | Posted | | Mean | Standard Deviation | mg/dL | | Birth to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Protein-enriched Human Milk Diet | Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. Protein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered | | OG001 | Usual Human Milk Diet | Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. Usual human milk diet: Human-based protein will not be added to the human milk administered. |
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| Other Pre-specified | Changes in Intestinal Microbiome | Determined by molecular analyses of fecal samples | | Not Posted | May 2026 | | | | | Birth to 36 weeks postmenstrual age | | Participants | | | | |
| Other Pre-specified | Cognitive Outcomes | Determined by Bayley assessment | | Not Posted | May 2026 | | | | | 2 years of corrected age | | Participants | | | | |