Table 2.
Effect of early KMC on primary and secondary outcomes.
| Standard care | Early KMC | Effect estimate (95% CI) | P value | |
|---|---|---|---|---|
| All-cause mortality at 28 days, No(%) | 34/139 (24) | 29/138 (21) | RR= 0.84 (0·55 – 1·29) |
0·423 |
| Time to death (h), median (IQR) |
N = 139 34 deaths |
N = 138 29 deaths |
HR= 0·83 (0·50 – 1·35) |
0·447 |
| 98·5 (29 – 132) |
90 (65 – 172) |
|||
| aSCRIP score at 24 h of enrolment, median, (IQR) | N = 135 | N = 134 | MD −0·05 (−0·25 – 0·16) |
0·667 |
| 5 (4 – 6) | 5 (4 – 5) | |||
| Hypothermia (T<36·5 °C) at 24 h of enrolment, No (%) | 55/135 (40) | 51/134 (38) | RR= 0·93 (0·69 – 1·26) |
0·654 |
| Exclusive breastfeedinga at discharge, No (%) | 105/107 (98) | 107/109 (98) | RR= 1.0 (0·96 – 1·04) |
0·985 |
| Clinically suspected infection from 3 – 28 days, No (%)b | 21/141 (15) | 28/138 (20) | RR= 1·36 (0·81 – 2·28) |
0·240 |
| Blood culture confirmed infectionc,d from 3 – 28 days, No (%) | 4/141 (3) | 6/138 (4) | RR= 1·53 (0·65– 3·64) |
0·333 |
| Duration of admission (days), mean (SD) | N = 106 | N = 108 | MD +0.3 (−60·5 – 75·1) |
0·833 |
| 16·3 (10·0) | 16·6 (11·1) | |||
| Weight gain at 28d (g/day), mean (SD) | N = 101 | N = 103 | MD −2·2 (−5·28 – 0·81) |
0·150 |
| 12·5 (12·1) |
10·3 (10·1) |
Exclusively breastfeeding defined as only receiving breastmilk and no formula milk supplementation.
Defined as neonates with at least 1 suspected infection, as per protocol definition.18 Two neonates (one in each allocation arm) each had two discrete infection episodes.
Blood cultures were obtained from 92% (47/51) of suspected late-onset infection episodes; 95% (21/22) from control arm and 90% (26/29) from intervention arm. 21% (10/47) of blood cultures were positive with 6% (3/47) presumed contaminated samples (coagulase negative staphylococcus isolated) and no between-arm difference in mean blood volume sampled (1.1 ml (SD 0.3) in control arm versus 1.0 ml (SD 0.3) in intervention arm, p = 0.238, student t-test).
CSF samples were obtained from 19 neonates meeting infection criteria and all were negative after 48 h culture.
Abbreviations: CI = confidence intervals; h = hours; HR = Hazard ratio; IQR = Interquartile range; KMC = kangaroo mother care; MD = mean/median difference in intervention arm; RR= risk ratio; SD = standard deviation.