Effect of a Multi-Strain Probiotic on Growth and Time to Reach Full Feeds in Preterm Neonates
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Setting
2.3. Study Participants
2.4. Randomization
2.5. Procedures
2.5.1. Probiotic/Placebo
2.5.2. Demographics and Medical Records
2.5.3. Anthropometry
2.5.4. Nutrition
2.5.5. Definitions Size at Birth
2.6. Statistical Analysis
2.7. Ethical Approval
3. Results
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Probiotic Group (n = 100) | Placebo Group (n = 100) | |
---|---|---|
Gender | ||
Male (n, %) | 47 (47) | 37 (37) |
Female (n, %) | 53 (53) | 63 (63) |
Birth weight | ||
750–1000 g (n, %) | 30 (30) | 32 (32) |
1001–1500 g (n, %) | 70 (70) | 68 (68) |
Gestational age | ||
26–28 weeks (n, %) | 34 (34) | 30 (30) |
29–32 weeks (n, %) | 60 (60) | 62 (62) |
33–36 weeks (n, %) | 6 (6) | 8 (8) |
HIV | ||
Exposed (n, %) | 22 (22) | 26 (26) |
Unexposed (n, %) | 78 (78) | 74 (74) |
Mode of delivery | ||
C-section (n, %) | 73 (73) | 73 (73) |
Vaginal delivery (n, %) | 27 (27) | 27 (27) |
Birth number | ||
Single neonate (n, %) | 79 (79) | 86 (86) |
Twin neonates (n, %) | 21 (21) | 14 (14) |
Probiotic Group n = 100 | Placebo Group n = 100 | |
---|---|---|
Time of initiating enteral feeds (DOL mean, SD, and range) | 3.1 ± 1.1 (0–6) | 3.0 ± 1.0 (2–6) |
Days to reach full feeds of 160 mL/kg/day (DOL mean, SD, and range) | 8.7± 2.0 (5–18) | 9.7 ± 4.3 (6–28) |
First feed received | ||
EBM (n, %) | 68 (68) | 69 (69) |
DEBM (n, %) | 12 (12) | 6 (6) |
PEBM (n, %) | 19 (19) | 25 (25) |
FM (n, %) | 1 (1) | 0 (0) |
Subsequent feeds received: * | ||
EBM (n, %) | 63 (63) | 66 (66) |
DEBM (n, %) | 13 (13) | 9 (9) |
PEBM (n, %) | 15 (15) | 24 (24) |
FM (n, %) | 9 (9) | 1 (1) |
Feeds fortified: | ||
FM85 | 76 (76) | 80 (80) |
MCT oil | 3 (3) | 2 (2) |
Probiotic Group n = 100 | Placebo Group n = 100 | |
---|---|---|
Size at birth | ||
SGA (n, %) | 17 (17) | 23 (23) |
AGA (n, %) | 80 (80) | 74 (74) |
LGA (n, %) | 3 (3) | 3 (3) |
Types of growth restriction in SGA neonates | ||
Symmetrical | 8 (8) | 9 (9) |
Asymmetrical | 9 (9) | 14 (14) |
Weight | ||
Birthweight in grams (mean, SD) | 1174 g; ±226 g | 1150 g; ±230 g |
Days to regain birthweight (DOL mean, SD and range) | 11.5 ± 6.3 (1 to 28) | 13.3 ± 6.3 (4 to >28) |
Estimated Difference | 95% CI | p-Value | |
---|---|---|---|
Weight | |||
On average over time | 33.7 | 11.0 to 56.4 | 0.004 * |
Day 7 | 2.9 | −20.1 to 25.9 | 0.81 |
Day 14 | 18.8 | −6.2 to 43.8 | 0.14 |
Day 21 | 56.7 | 29.3 to 84.0 | <0.001 * |
Day 28 | 83.7 | 54.3 to 113.2 | <0.001 * |
Length | |||
On average over time | 0.1 | −0.1 to 0.2 | 0.33 |
Day 7 | 0.0 | −0.1 to 0.1 | 0.83 |
Day 14 | −0.0 | −0.1 to 0.1 | 0.96 |
Day 21 | 0.1 | −0.0 to 0.2 | 0.10 |
Day 28 | 0.2 | 0.1 to 0.3 | 0.006 * |
Head circumference | |||
On average over time | 0.1 | −0.2 to 0.4 | 0.46 |
Day 7 | −0.4 | −0.8 to 0.1 | 0.13 |
Day 14 | 0.3 | −0.2 to 0.8 | 0.25 |
Day 21 | 0.3 | −0.2 to 0.9 | 0.25 |
Day 28 | 0.4 | −0.2 to 1.1 | 0.17 |
Estimated Difference | 95% CI | p-Value | |
---|---|---|---|
Weight | |||
On average over time | 0.08 | 0.01 to 0.16 | 0.03 * |
Day 7 | 0.01 | −0.07 to 0.08 | 0.88 |
Day 14 | 0.05 | −0.03 to 0.13 | 0.23 |
Day 21 | 0.12 | 0.03 to 0.21 | 0.007 * |
Day 28 | 0.22 | 0.13 to 0.32 | <0.001 * |
Length | |||
On average over time | 0.08 | −0.09 to 0.25 | 0.35 |
Day 7 | −0.08 | −0.28 to 0.13 | 0.45 |
Day 14 | 0.17 | −0.05 to 0.40 | 0.13 |
Day 21 | 0.16 | −0.09 to 0.41 | 0.20 |
Day 28 | 0.19 | −0.08 to 0.46 | 0.16 |
Head circumference | |||
On average over time | 0.00 | 0.16 to 0.16 | 0.98 |
Day 7 | −0.02 | −0.18 to 0.14 | 0.78 |
Day 14 | −0.05 | −0.22 to 0.11 | 0.51 |
Day 21 | 0.03 | −0.14 to 0.20 | 0.70 |
Day 28 | 0.09 | −0.09 to 0.26 | 0.33 |
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Sowden, M.; van Niekerk, E.; Bulabula, A.N.H.; Twisk, J.; van Weissenbruch, M.M. Effect of a Multi-Strain Probiotic on Growth and Time to Reach Full Feeds in Preterm Neonates. Nutrients 2022, 14, 4658. https://doi.org/10.3390/nu14214658
Sowden M, van Niekerk E, Bulabula ANH, Twisk J, van Weissenbruch MM. Effect of a Multi-Strain Probiotic on Growth and Time to Reach Full Feeds in Preterm Neonates. Nutrients. 2022; 14(21):4658. https://doi.org/10.3390/nu14214658
Chicago/Turabian StyleSowden, Marwyn, Evette van Niekerk, Andre Nyandwe Hamama Bulabula, Jos Twisk, and Mirjam Maria van Weissenbruch. 2022. "Effect of a Multi-Strain Probiotic on Growth and Time to Reach Full Feeds in Preterm Neonates" Nutrients 14, no. 21: 4658. https://doi.org/10.3390/nu14214658