Open Access

The Effect of Oral Protein Supplementation on the Growth of Very Low Birth Weight Preterm Infants Admitted to the Neonatal Intensive Care Unit: A Randomized Clinical Trial


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Figure 1.

The CONSORT flow chart of the study population.
The CONSORT flow chart of the study population.

The comparison of laboratory data of neonates in the protein supplement and control groups during trial

Test Week Groups P-value*

Protein Supplement(n=36) Control group(n=36)
BUN (mg/dl), mean ± SD Baseline 6.06 ± 1.39 6.71 ± 2.80 0.216
1 5.56 ± 1.24 6.39 ± 2.39 0.069
2 5.97 ± 1.21 5.84 ± 1.97 0.739
Albumin (g/dL), mean ± SD Baseline 3.18 ± 0.33 3.13 ± 0.41 0.570
1 3.41 ± 0.40 3.21 ± 0.37 0.031
2 3.59 ± 0.37 3.24 ± 0.40 0.000
PH, mean ± SD Baseline 7.34 ± 0.05 7.33 ± 0.06 0.044
1 7.33 ± 0.04 7.36 ± 0.05 0.006
2 7.33 ± 0.06 7.36 ± 0.04 0.015
PCO2 (mmHg), mean ± SD Baseline 35.12 ± 6.54 35.97 ± 5.10 0.544
1 39.20 ± 5.93 35.41 ± 5.95 0.008
2 41.53 ± 6.68 34.63 ± 7.82 0.000
HCO3 (mmol/L), mean ± SD Baseline 18.19 ± 4.33 18.39 ± 4.87 0.854
1 20.47 ± 5.03 19.63 ± 4.72 0.008
2 21.06 ± 5.25 19.58 ± 4.67 0.004

The comparison of protein intake, duration of trial, and anthropometric parameters (outcomes) in the intervention and control groups

Variable Groups P-value*

Protein supplementn=36 Controln=36
Protein Intake(gr/kg/day), mean ± SD 4.55 ± 0.18 3.66 ± 0.22 <0.001
Duration of trial (days), mean ± SD 10.39 ± 4.42 12.50 ± 5.71 0.097
Weight (gram), mean ± SD
Before intervention (gr) 1276.52 ± 127.23 1282.06 ± 118.30 0.854
After intervention (gr) (Discharge time) 1518.79 ± 59.78 1455.88 ± 50.38 <0.001
Gain (gr/kg/day) 19.12 ± 7.22 11.14 ± 5.29 <0.001
Weight Percentile, n (%) 0.040
After intervention
≤ 3 6 (16.7) 16 (44.4)
3 – 10 16 (44.4) 11 (30.6)
> 10 14 (38.9) 9 (25.0)
Increased head circumference rate (cm/week), mean ± SD 0.872 ± 0.262 0.525 ± 0.210 <0.001
Increased length rate (cm/week), mean ± SD 1.00 ± 0.35 0.62 ± 0.20 <0.001

Comparison of baseline characteristics of the neonates in the intervention and control groups before the clinical trial

Variable Groups P-value*

Protein supplementn=36 Controln=36
Gender, n (%) 0.345
Male 17 (47.2) 21 (58.3)
Female 19 (52.8) 15 (41.7)
Birth weight (gr), mean ± SD 1210.3 ± 189.53 1229.7 ± 169.6 0.660
Birth weight percentile, n (%) 0.798
≤ 3 3 (8.3) 1 (2.8)
3 – 10 4 (11.1) 5 (13.9)
> 10 29 (80.6) 30 (83.3)
Gestational age (weeks), mean ± SD 30.50 ± 1.83 30.58 ± 1.70 0.850
Gestational age groups (weeks), n (%) 0.735
< 29 12 (33.3) 9 (25.0)
29 – 31 11 (30.6) 12 (33.3)
31 – 33 13 (36.1) 15 (41.7)
Birth head circumference (cm), mean ± SD 26.6 ± 1.7 27.0 ± 1.5 0.600
Birth length(cm), mean ± SD 37.5 ± 17.63 37.3 ± 15.75 0.665
Age (days), mean ± SD 13.7 ± 9.0 11.6 ± 7.1 0.291
Type of milk, n (%) 1.000
Formula 19 (52.8) 19 (52.8)
FBM 17 (47.2) 17 (47.2)
Type of formula, n (%) 1.000
Pre BeBeLac 8 (47.1) 7 (38.9)
Pre Aptamil 4 (23.5) 5 (27.8)
Pre NAN 4 (23.5) 5 (27.8)
BeBeLac AR 1 (5.9) 1 (5.6)
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