Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
Abstract
:1. Introduction
2. Methods
2.1. Study Design and Participants
2.2. Randomization and Study Group Allocation
2.3. Feeding Protocol
2.4. Study Outcomes
2.5. Statistical Analysis
3. Results
3.1. Participants
3.2. Feeding Advancement
3.3. Growth
3.4. Tolerance Measures, Indicators of Respiratory Status, and Global Morbidity
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Appendix A
Day of Life | 1 | 2 | 3 | 4 | 5 | 6 | 7 | Max. |
---|---|---|---|---|---|---|---|---|
Calories (k/kg/day) | 40 | 50 | 65 | 75 | 85 | 90 | 100 | 110 |
Glucose (g/kg/day) | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 14 |
Lipids (g/kg/day) | 0.5 | 1.0 | 1.5 | 2.0 | 2.5 | 3.0 | 3.0 | 3.5 |
Proteins (g/kg/day) | 2.0 | 2.5 | 3.0 | 3.5 | 3.5 | 3.5 | 3.5 | 4.0 |
Calcium (mg/kg/day) | 40 | 50 | 60 | 65 | 65 | 65 | 65 | 70 |
Phosphorus (mg/kg/day) | 20 | 30 | 40 | 45 | 45 | 45 | 55 | |
Magnesium(mg/kg/day) | 5 | 5 | 5 | 5 | 5 | 10 |
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Characteristics | Study Formula * | |
---|---|---|
IPF | EHF | |
Nutrient density (cal/fl oz) | 24 | 24 |
Nutrient composition per 100 kcal | ||
Total Protein (g, % calories) † | 3.0, 12% | 2.8, 11% |
Total Carbohydrate (g, % calories) ‡ | 11, 44% | 10.2, 41% |
Total Fat (g, % calories) § | 5.1, 44% | 5.6, 48% |
Arachidonic acid (ARA), mg | 34 | 34 |
Docosahexaenoic acid (DHA), mg | 17 | 17 |
Potential Renal Solute Load (mOsm/100 Cal) | 27 | 25 |
Potential Renal Solute Load (mOsm/100 mL) | 21 | 21 |
Osmolality (mOsm/kg H2O) | 310 | 340 |
Osmolarity (mOsm/L) | 270 | 300 |
Infant Characteristics | Study Group | p | |
---|---|---|---|
IPF | EHF | ||
Gender, n (%) | |||
Male | 17 (56.7) | 16 (53.3) | 0.795 |
Female | 13 (43.3) | 14 (46.7) | |
Birth type, n (%) | |||
Singleton | 15 (50) | 17 (56.7) | 0.605 |
Twin | 15 (50) | 13 (43.3) | |
Caesarean Section, n (%) | 26 (86.7) | 26 (86.7) | 1.000 |
Apgar score, n (%) | |||
6–7 | 3 (10.0) | 6 (20) | 0.760 |
8 | 6 (20.0) | 6 (20) | |
9 | 16 (53.3) | 12 (40) | |
10 | 5 (16.7) | 6 (20) | |
Gestational age (days) * | 30.1 (1.6) | 30.9 (1.9) | 0.803 |
Birth anthropometrics * | |||
Weight (g) | 1278.7 (259.7) | 1301 (293.2) | 0.756 |
Length (cm) | 38.1 (2.8) | 38.1 (3.3) | 0.973 |
Head circumference (cm) | 27.3 (1.7) | 27.7 (2.4) | 0.481 |
Tolerance Outcomes | Primary Analysis | p | Subset Analysis | p | ||
---|---|---|---|---|---|---|
IPF, n = 30 | EHF, n = 30 | IPF, n = 11 | EHF, n = 12 | |||
Number of stools/day * | 2 (0.8) | 2 (0.9) | 0.525 | 1 (0.5) | 2 (0.9) | 0.160 |
Abdominal distention ** | 0 | 0 | 1 | 0 | 0 | 1 |
Regurgitation/emesis ** | 21 | 18 | 1 | 29 | 18 | 0.684 |
Feedings withheld ≥4 h ** | 14 | 25 | 0.060 | 14 | 25 | 0.400 |
Bloody stools ** | 0 | 0 | 0.472 | 0 | 0 | 1 |
Parenteral nutrition, days * | 11 (7.1) | 15 (12.3) | 0.181 | 10 (6.5) | 15 (12.6) | 0.315 |
Global morbidities, n (%) | ||||||
Early-onset sepsis | 2 (6.7) | 3 (10) | 0.640 | 1 (9.1) | 1(8.3) | 0.739 |
Late-onset sepsis | 6 (20) | 6 (20) | 1.000 | 2 (18.2) | 3 (25) | 0.545 |
BDP | 0 (0) | 3 (10) | 0.119 | 0 (0) | 1 (8.3) | 0.522 |
IVH | 1(3.3) | 4 (13.3) | 0.177 | 0 (0) | 0 (0) | 1.000 |
ROP | 5 (16.7) | 7 (23.3) | 0.519 | 1 (9.1) | 4 (33.3) | 0.185 |
EUGR | 18 (60) | 16 (53.3) | 0.602 | 8 (72.7) | 9 (75) | 0.635 |
Hospitalization, days † | 44 (38–50) | 49 (34–64) | 0.236 | 49 (36–62) | 44 (28–60) | 0.871 |
Postmenstrual age at discharge, weeks * | 37 (2.1) | 38 (2.8) | 0.229 | 37 (2.1) | 38 (1.9) | 0.740 |
Weight at discharge, g * | 2141 (391) | 2140 (283) | 0.996 | 2176 (293) | 2128 (204) | 0.704 |
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Baldassarre, M.E.; Di Mauro, A.; Fanelli, M.; Capozza, M.; Wampler, J.L.; Cooper, T.; Laforgia, N. Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial. Int. J. Environ. Res. Public Health 2019, 16, 2911. https://doi.org/10.3390/ijerph16162911
Baldassarre ME, Di Mauro A, Fanelli M, Capozza M, Wampler JL, Cooper T, Laforgia N. Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial. International Journal of Environmental Research and Public Health. 2019; 16(16):2911. https://doi.org/10.3390/ijerph16162911
Chicago/Turabian StyleBaldassarre, Maria Elisabetta, Antonio Di Mauro, Margherita Fanelli, Manuela Capozza, Jennifer L. Wampler, Timothy Cooper, and Nicola Laforgia. 2019. "Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial" International Journal of Environmental Research and Public Health 16, no. 16: 2911. https://doi.org/10.3390/ijerph16162911