Table 2 Primary and secondary clinical outcomes and compliance measures.
Primary outcome (intent-to-treat analysis) | Overall (N = 76) | Conventional (N = 36) | Study (N = 40) | P value |
|---|---|---|---|---|
A priori clinical outcome, Success, N (%) | 29 (38) | 16 (44) | 13 (33) | 0.28 |
Secondary outcomes | Overall (N = 72) | Conventional (N = 35) | Study (N = 37) | P value |
|---|---|---|---|---|
I-GERQ-R decrease by 6—N (%) | 24/65 (37) | 11/31 (35) | 13/34 (38) | 0.82 |
Feeding outcome at Time-2—N (%) | 0.26 | |||
PO | 51 (71) | 27 (77) | 24 (65) | |
Transition (PO + Tube) | 18 (25) | 8 (23) | 10 (27) | |
Tube | 3 (4) | 0 (0) | 3 (8) | |
Length of hospital stay—days | 108 [82–129] | 108 [83–125] | 98 [81–132] | 0.89 |
Hospital stay inception to discharge—days | 25 [11–45] | 23 [3–39] | 27 [16–47] | 0.26 |
Weight growth velocity (GV)—g/day | 27.1 (9.4) | 26.5 (7.2) | 27.6 (11.1) | 0.64 |
Length GV—cm/daya | 0.1 (0.1) | 0.1 (0.1) | 0.1 (0.1) | 0.88 |
Head circumference GV—cm/daya | 0.1 [0.0–0.1] | 0.1 [0.0–0.1] | 0.1 [0.0–0.1] | 0.87 |
Feeding method at discharge—N (%) | 0.32 | |||
PO | 54 (75) | 29 (83) | 25 (68) | |
Transition (PO + Tube) | 14 (19) | 5 (14) | 9 (24) | |
Tube | 4 (6) | 1 (3) | 3 (8) | |
Oxygen requirement at discharge—N (%) | 16 (22) | 9 (26) | 7 (19) | 0.49 |
Compliance to feeding methods | ||||
Total Fluid Volume (TFV) | ||||
TFV at inception—# | N/A | 150 [147, 152] | 150 [149, 156] | 0.8 |
TFV at time-2—# | N/A | 143 [134, 148]a | 133 [126, 137]a | <0.001 |
# days TFV < 140/kg/d | N/A | 10 [2, 26] | 22 [11, 31] | 0.005 |
TFV compliance (TFV < 140/kg/d for >75% of time) | N/A | 9 (26) | 27 (73) | <0.001 |
Position | ||||
Feeding position, RSL, % | N/A | 5 [1, 17] | 78 [12, 94] | <0.001 |
Feeding in RSL > 75% of the time, % | N/A | 0 (0) | 21 (57) | <0.001 |
Supine position postprandial, % | N/A | 50 [40, 66] | 87 [74, 96] | <0.001 |
Supine position postprandial > 75% of the time, % | N/A | 7/34 (21) | 27/36 (75) | <0.001 |
Feeding duration | ||||
% time feed duration >30 min, % | N/A | 4 [0, 37] | 15 [0, 69] | 0.15 |
Feeding duration at inception, min | N/A | 23 [17, 41] | 30 [19, 34] | 0.64 |
Feeding duration at Time-2, min | N/A | 23 [19, 28] | 26 [20, 30] | 0.15 |
Long-term follow-upb | ||||
Feeding method at 6 months—N (%) | 0.65 | |||
PO | 36/50 (72) | 21/27 (78) | 15/23 (65) | |
Transition (PO + Tube) | 10/50 (20) | 4/27 (15) | 6/23 (26) | |
Tube | 4/50 (8) | 2/27 (7) | 2/23 (9) | |
Feeding method at 1 year—N (%) | 0.11 | |||
PO | 37/44 (84) | 20/22 (91) | 17/22 (77) | |
Transition (PO + Tube) | 4/44 (9) | 0/22 (0) | 4/22 (18) | |
Tube | 3/44 (7) | 2/22 (9) | 1/22 (5) | |
CCA BSID-III | ||||
Cognitive Score <80—N (%) | 9/44 (21) | 5/23 (22) | 4/21 (19) | 1.00 |
Cognitive Score—# | 95 [90–105] | 100 [90–105] | 90 [90–100] | 0.11 |
Receptive Communication <80—N (%) | 14/42 (33) | 8/23 (35) | 6/19 (32) | 0.83 |
Receptive Communication Score—# | 90 [77–103] | 91 [74–103] | 89 [77–103] | 0.75 |
Expressive Communication <80—N (%) | 11/25 (44) | 7/14 (50) | 4/11 (36) | 0.69 |
Expressive Communication Score—# | 86 [71–100] | 81 [71–94] | 89 [71–103] | 0.66 |
Fine Motor <80—N (%) | 11/41 (27) | 5/23 (22) | 6/18 (33) | 0.49 |
Fine Motor Score—# | 94 [79–103] | 97 [82–110] | 88 [70–97] | 0.13 |
