Table 3.
Sub-group analysis of eKMC trial outcomes, by admission weight and twin status.
| Subgroup | No / Total No (%) | Effect size (95% CI); P for effect of intervention within each sub-group stratum | P value for test for interaction between treatment arms and sub-group strata | ||
|---|---|---|---|---|---|
| Standard care (n = 139) | Early KMC (n = 138) | ||||
| All-cause mortality at 28 days, No (%) | Admission weight <1200 g | 19/37 (51) | 14/31 (45) | RR 0·88 (0·53 – 1·45); 0·614 |
0·849 |
| Admission weight ≥1200 g | 15/102 (15) | 15/107 (14) | RR 0·95 (0·49 – 1·85); 0·888 |
||
| Singleton | 25/94 (27) | 21/97 (22) | RR 0·98 (0·42 – 2·29); 0·955 |
0·721 | |
| Twin pregnancy | 9/45 (20) | 8/41 (20) | RR 0·81 (0·49 – 1·35); 0·426 |
||
| Time to death, (h), median | Admission weight <1200 g (n = 19; n = 14) |
95 | 82 | HR: 0·86 (0·43 – 1·71); 0·665 |
0·888 |
| Admission weight ≥1200 g (n = 15; n = 15) |
107 | 151 | HR: 0·92 (0·45 – 1·89); 0·825 |
||
| Singleton (n = 25; n = 21) |
71 | 109 | HR: 0·75 (0·42 – 1·34); 0·334 |
0·593 | |
| Twin pregnancy (N = 9; n = 8) |
123 | 76 | HR 1.02 (0.39 – 2.64); 0.970 |
||
| aSCRIP score at 24 h, mean | Admission weight <1200 g (n = 36; n = 28) |
4·6 | 4·6 | MD 0 (−0·36 – 0·48); 0·780 |
0·490 |
| Admission weight ≥1200 g (n = 99; n = 106) |
5·1 | 5·0 | MD −0·1 (−0·34 – 0·12); 0·358 |
||
| Singleton (n = 90; n = 94) |
4·9 | 4·9 | MD 0 (−0·24 – 0·25); 0·970 |
0·509 | |
| Twin pregnancy (n = 45; n = 40) |
5·0 | 4·9 | MD −0·1 (−0·51 – 0·22); 0·440 |
||
| Hypothermia (T<36·5 °C) at 24 h, No (%) | Admission weight <1200 g | 25/36 (691) | 11/28 (39) | RR 0·54 (0·33 – 0·90); 0·018 |
0·008 |
| Admission weight ≥1200 g | 29/99 (29) | 40/106 (38) | RR 1·29 (0·87 – 1·91); 0·206 |
||
| Singleton | 41/90 (46) | 30/94 (32) | RR 0·70 (0·48 – 1·02); 0·061 |
0·008 | |
| Twin pregnancy | 14/45 (31) | 21/40 (53) | RR 1·69 (1·0 – 2·86); 0·051 |
||
| Exclusive breast feedinga at discharge, No (%) | Admission weight <1200 g | 18/18 (100) | 17/17 (100) | RR 1·0 (0·96 – 1·05); 0·.973 |
NA |
| Admission weight ≥1200 g | 87/89 (98) | 90/92 (98) | RR 1·0 (0·96 – 1·05); 0·973 |
||
| Singleton | 71/71 (100) | 75/76 (99) | RR 1·0 (0·93–1·13); 0·605 |
NA |
|
| Twin pregnancy | 34/36 (94) | 32/33 (97) | RR 1·0 (0·93 – 1·13); 0·605 |
||
|
Clinically suspected infection from 3 – 28 days, No (%) |
Admission weight <1200 g | 9/37 (24) | 10/31 (32) | RR 1·33 (0·62 – 2·85); 0·470 |
0·856 |
| Admission weight ≥1200 g | 12/104 (12) | 18/107 (17) | RR 1·46 (0·74 – 2·88); 0·277 |
||
| Singleton | 16/96 (17) | 22/97 (23) | RR 1·36 (0·76 – 2·43); 0·298 |
0·959 | |
| Twin pregnancy | 5/45 (11) | 6/41 (15) | RR 1·32 (0·43 – 4·0); 0·627 |
||
| Blood culture confirmed infection from 3 – 28 days, No (%) | Admission weight <1200 g | 0/37 (0) | 1/31 (3) | RR 1·21 (0·33 – 4·41); 0·767 |
NA |
| Admission weight ≥1200 g | 4/104 (4) | 5/107 (5) | RR 1·21 (0·33 – 4·41); 0·767 |
||
| Singleton | 2/96 (2) | 3/97 (3) | RR 1·48 (0·25 – 8·71); 0·662 |
0·935 | |
| Twin pregnancy | 2/45 (4) | 3/41 (7) | RR 1·65 (0·29 – 9·39); 0·575 |
||
| Duration of admission (h), mean | Admission weight <1200 g (n = 17; n = 17) |
705·5 | 677·4 | MD −28·1 (−174·5 – 118·4); 0·707 |
0·595 |
| Admission weight ≥1200 g (n = 89; n = 91) |
332·0 | 347·3 | MD 15·2 (−48·4 – 78·9); 0·639 |
||
| Singleton (n = 70; n = 75) |
410·8 | 404·1 | MD −6·7 (−88·9 – 75·5); 0·873 |
0·591 | |
| Twin pregnancy (n = 36; n = 33) |
355·2 | 388·2 | MD 33·0 (−86·2 – 152·2); 0·588 |
||
| Weight gain at 28+/−5d (g/day), mean | Admission weight <1200 g (n = 17; n = 16) |
6·1 | 6·9 | MD 0·8 (−6·64 – 8·19); 0·837 |
0·369 |
| Admission weight ≥1200 g (n = 83; n = 88) |
13·9 | 10·9 | MD −2·9 (−6·19 – 0·33); 0·078 |
||
| Singleton (n = 65; n = 72) |
12·9 | 11·2 | MD −1·7 (−5·38 – 2·03); 0·377 |
0·548 | |
| Twin pregnancy (n = 35; n = 32) |
11·9 | 8·2 | MD −3·7 (−8·95 – 1·64); 0·177 |
||
Exclusively breastfeeding defined as only receiving breastmilk and no formula milk supplementation.
Abbreviations: CI = confidence intervals; h = hours; HR = Hazard ratio; IQR = Interquartile range; KMC = kangaroo mother care; MD = mean difference in intervention arm; NA = Not available; RR= risk ratio; SD = standard deviation.