Trial Outcomes & Findings for Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU (NCT NCT04025021)
NCT ID: NCT04025021
Last Updated: 2023-02-23
Results Overview
Body composition will be measured by air displacement plethysmography (PEAPod). As standardized assessment of body composition is relatively new in the preterm infant population, we are using clinical judgment to determine that a difference in fat free mass z-score (from data from Norris T, 2019) of 0.5 is clinically significant.
TERMINATED
NA
3 participants
4 weeks after baby reaches full feeds (150 mL/kg/day) or at NICU discharge
2023-02-23
Participant Flow
Participant milestones
| Measure |
Control Group (Standard Fortification)
Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. As feedings are advanced to goal of 150 ml/kg/day, the TPN and SMOF lipids (Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil) will be decreased per standard management and NICU guidelines.
|
Intervention Group (Targeted Fortification)
Breast milk (BM) will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml BM at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. During this time, as the volume decreases, the TPN and SMOF lipids will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional liquid protein and/or lipids will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day. BM analysis will occur on a weekly basis immediately after birth for all infants enrolled in the study.
Targeted Fortification: parenteral nutrition will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional protein and/or fat will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day.
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|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Control Group (Standard Fortification)
Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. As feedings are advanced to goal of 150 ml/kg/day, the TPN and SMOF lipids (Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil) will be decreased per standard management and NICU guidelines.
|
Intervention Group (Targeted Fortification)
Breast milk (BM) will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml BM at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. During this time, as the volume decreases, the TPN and SMOF lipids will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional liquid protein and/or lipids will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day. BM analysis will occur on a weekly basis immediately after birth for all infants enrolled in the study.
Targeted Fortification: parenteral nutrition will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional protein and/or fat will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day.
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|---|---|---|
|
Overall Study
Study discontinued with onset of COVID-19 pandemic
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group (Standard Fortification)
n=2 Participants
Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. As feedings are advanced to goal of 150 ml/kg/day, the TPN and SMOF lipids (Fat Emulsion Comprised of Soy Oil, Medium Chain Triglycerides, Olive Oil, and Fish Oil) will be decreased per standard management and NICU guidelines.
|
Intervention Group (Targeted Fortification)
n=1 Participants
Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at 75 ml/kg/day. During this time, as the volume decreases, the TPN and SMOF lipids will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional liquid protein and/or microlipids will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day. Breast milk analysis will occur on a weekly basis immediately after birth for all infants enrolled in the study.
Targeted Fortification: The TPN and SMOF lipids will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional liquid protein and/or microlipids will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day.
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Total
n=3 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
28.5 weeks
n=2 Participants
|
29 weeks
n=1 Participants
|
28.8 weeks
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
1 participants
n=1 Participants
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after baby reaches full feeds (150 mL/kg/day) or at NICU dischargePopulation: Study discontinued due to onset of COVID pandemic. No data were collected for this Outcome Measure.
Body composition will be measured by air displacement plethysmography (PEAPod). As standardized assessment of body composition is relatively new in the preterm infant population, we are using clinical judgment to determine that a difference in fat free mass z-score (from data from Norris T, 2019) of 0.5 is clinically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment in study to 4 weeks after full feeds (150 mL/kg/day) or at NICU discharge.Population: Study discontinued due to onset of COVID pandemic. No data were collected for this Outcome Measure.
Weight gain velocity, measured in grams/kg/day
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.Population: Study discontinued due to onset of COVID pandemic. No data were collected for this Outcome Measure.
Daily weight will be obtained, measured in grams
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.Population: Study discontinued due to onset of COVID pandemic. No data were collected for this Outcome Measure.
Weekly measurements of length will be obtained throughout the study, measured in centimeters
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.Population: Study discontinued due to onset of COVID pandemic. No data were collected this Outcome Measure.
Weekly measurements of head circumference will be obtained throughout the study, measured in centimeters
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment in study to 4 weeks at full feeds (150 mL/kg/day) or at NICU discharge.Population: Study discontinued due to onset of COVID pandemic. No data were collected for this Outcome Measure.
Mid upper arm circumference (cm) or skinfold thickness (mm) will be measured weekly throughout the study and combined with length to calculate the body composition
Outcome measures
Outcome data not reported
Adverse Events
Control Group (Standard Fortification)
Intervention Group (Targeted Fortification)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place