Early lactase enzyme supplementation: Efficacy to promote growth and feeding tolerance in preterm infants: A randomized controlled trial

Table 1 Clinical and demographic characteristics between the studied groups, n (%)/mean ± SD

Variable	Intervention group (n = 55)	Control group (n = 54)	P value
Male gender	26 (47.3)	27 (50.0)	0.4629
GA (weeks)	31.5 ± 1.84	31.5 ± 1.57	0.976
Birth weight (kg)	1.5 ± 0.289	1.51 ± 0.343	0.855
Mode of delivery (CS)	45 (81.8)	39 (72.2)	0.2616
PROM incidence	15 (27.3)	12 (22.2)	0.6582
Admission diagnosis
RDS	47 (85.4)	41 (75.9)
PH	6 (11)	9 (16.7)	0.204
IUGR	1 (1.8)	0 (0)
HDFN	0 (0)	3 (5.5)
HIE	1 (1.8)	1 (1.9)
Feeding type
Exclusive breast milk	2 (3.6)	1 (1.9)	0.3623
PT formula	46 (83.6)	38 (70.4)
Breast and PT formula	5 (9.0)	11 (20.4)
AR	2 (3.6)	4 (7.4)
History of maternal comorbidity	16 (29)	23 (42.5)	0.141

GA: Gestational age; CS: Cesarean section; PROM: Premature rupture of membranes; RDS: Respiratory distress syndrome; PH: Pulmonary hypertension; IUGR: Intrauterine growth retardation; HDFN: Hemolytic disease of the fetus and newborn; HIE: Hypoxic-ischemic encephalopathy; PT: Preterm; AR: Anti-regurgitation.

Table 2 Laboratory findings between the studied groups at study entry and at the 2^nd week, mean ± SD

Variable	Intervention group (n = 55)	Control group (n = 54)	P value
Hb (g/dL)
At study entry	16.55 ± 2.7	15.8 ± 2.4	0.131
At 2nd week	12.95 ± 2.16	12.89 ± 2.4	0.895
TLC (× 103/mL)
At study entry	11.0 ± 4.6	10.6 ± 4.94	0.691
At 2nd week	11.94 ± 5.16	14.2 ± 6.759	0.053
PLT (× 103/mL)
At study entry	255.6 ± 87.82	256.9 ± 104.4	0.956
At 2nd week	282.7 ± 139.1	296.3 ± 130.2	0.599
CRP (mg/L)
At study entry	3.1 ± 2.5	3.27 ± 1.98	0.786
At 2nd week	10.3 ± 30.2	7.1 ± 15.51	0.486

Hb: Hemoglobin; TLC: Total leukocytic count; PLT: Platelets; CRP: C-reactive protein.

Table 3 Anthropometric parameters between the studied groups at study entry and at the 2^nd week, mean ± SD

Variable	Intervention group (n = 55)	Control group (n = 54)	P value
Weight (kg)
1st week	1.436 ± 0.268	1.42 ± 0.30	0.899
2nd week	1.706 ± 0.299	1.62 ± 0.318	0.199
Height (cm)
1st week	41.2 ± 2.69	41.13 ± 2.82	0.854
2nd week	43.3 ± 2.95	43.0 ± 2.903	0.617
HC (cm)
1st week	29.14 ± 1.76	29.29 ± 1.781	0.658
2nd week	30.79 ± 1.85	30.8 ± 1.78	0.924

HC: Head circumference.

Table 4 Feeding intolerance parameters between the studied groups at the 1^st and 2^nd week, n (%)

Variable	Intervention group (n = 55)	Control group (n = 54)	P value
Gastric residual
1st week	13 (23.6)	32 (59.3)	0.0002
2nd week	9 (16.4)	23 (42.6)	0.003
Abdominal distension
1st week	31 (56.4)	44 (81.5)	0.007
2nd week	14 (25.5)	40 (74.1)	< 0.001
Emesis
1st week	5 (9.1)	19 (35.2)	0.001
2nd week	1 (1.8)	2 (3.7)	0.62
Diarrhea
1st week	3 (5.5)	14 (25.9)	0.004
2nd week	1 (1.8)	11 (20.4)	0.002

Table 5 Reducing substance (Benedict’s test) in stool at the 1^st and 2^nd week between the studied groups, and in-group comparison, n (%)

Variable	Intervention group (n = 55)	Control group (n = 54)	P value
Reducing substance in stool at 1st week
Negative	22 (40.0)	12 (22.2)	0.01185
Trace (< 500 mg/dL)	5 (9.1)	7 (13.0)
+ (500-1000 mg/dL)	26 (47.3)	23 (42.6)
++ (1000-1500 mg/dL)	2 (3.6)	11 (20.4)
+++ (1500-2000 mg/dL)	0 (0.0)	1 (1.9)
Reducing substance in stool at 2nd week
Negative	38 (69.1)	7 (13.0)	< 0.001
Trace (< 500 mg/dL)	5 (9.1)	3 (5.6)
+ (500-1000 mg/dL)	10 (18.2)	23 (42.6)
++ (1000-1500 mg/dL)	2 (3.6)	18 (33.3)
+++ (1500-2000 mg/dL)	0 (0.0)	3 (5.6)
In-group comparison	P < 0.001	P = 0.2274

Benedict’s test interpretation: Negative: Blue solution; Trace: Green solution; +: Green ppt; ++: Yellow ppt; +++: Orange ppt.

Table 6 Stool pH analysis after the 1^st and 2^nd week between the studied groups, mean ± SD

Stool pH	Intervention group (n = 55)	Control group (n = 54)	P value
1st week	6.32 ± 0.69	5.7 ± 0.9	< 0.0001
2nd week	6.5 ± 0.98	5.3 ± 0.72	< 0.0001

Table 7 Primary and secondary outcomes between the studied groups, n (%)/mean ± SD

Variable	Intervention group (n = 55)	Control group (n = 54)	P value
Primary outcome
Weight gain (g/day)	18.9 ± 9.5	12.3 ± 6.3	< 0.0001
Days to reach full enteral feeding (days)	15.0 ± 8.24	16.9 ± 8.45	0.250
NEC incidence	3 (5.5)	10 (18.5)	0.0448
Secondary outcome
Sepsis incidence	8 (14.5)	8 (14.8)	1.0
Hospital stay (days)	23.6 ± 8.24	25.7 ± 8.45	0.339
Fate
Discharged	47 (85.5)	46 (85.2)	1.0
Died	8 (14.5)	8 (14.8)

NEC: Necrotizing enterocolitis.