Table 1.
Baseline characteristics of the intention-to-treat population.
| Standard care (N = 141) | early KMC (N = 138) | |
|---|---|---|
| Neonatal & perinatal characteristics | ||
| Male sex, No (%) | 59 (42) | 59 (43) |
| Age at admission (h), median (IQR) | 2·3 (0·7 – 5) | 2·3 (0·9 – 4·7) |
| Age at start of intervention/controla (h), median (IQR) | 12·8 (7·9 – 19·1) | 13·6 (8·9 – 19) |
| Admission weight (g), median (IQR) | 1436 (1180 - 1660) | 1459 (1204 – 1650) |
| Distribution of admission weight,b No (%) | ||
| <1200 g | 39 (28) | 34 (25) |
| ≥1200 g | 102 (72) | 104 (75) |
| Part of twin gestation pregnancy, No (%) | 45 (32) | 41 (30) |
| Part of twin pregnancy, both enroled, No (%) | 24 (17) | 24 (17) |
| Gestational age (weeks), median (IQR) (n = 271) | 32 (31 - 34) | 33 (31 - 34) |
| Distribution of gestational age, No (%) | ||
| <28 weeks | 4/135 (3) | 3/136 (2) |
| 28 – 31+6 weeks | 36/135 (27) | 41/136 (30) |
| 32 – 36+6 weeks | 83/135 (61) | 81/136 (60) |
| ≥37 weeks | 12/135 (9) | 11/136 (8) |
| Referral-site (EFSTH), No (%) | 66 (47) | 66 (48) |
| Health facility delivery, No (%) | 121 (86) | 126 (91) |
| Caesarean-section delivery, No (%) | 27 (19) | 31 (22) |
| Resuscitation at delivery,c No (%) | 10/140 (7) | 5 (4) |
| Perinatal septic risk factors,d No (%) | 49/139 (35) | 40/137 (29) |
| Neonatal stability & management at start of intervention/control procedures | ||
| Stability status,e No (%) | ||
| Stablef | 5 (4) | 14 (10) |
| Mildly unstable | 86 (61) | 73 (53) |
| Moderately unstable | 44 (31) | 44 (32) |
| Severely unstablef | 5 (4) | 2 (1) |
| Axillary temperature ( °C), median (IQR)(n = 277) | 36·6 (36·1 – 37·2) | 36·6 (36·1 – 37·1) |
| Blood glucose (mmol/L), median (IQR)(n = 275) | 4·1 (3·5 – 5·1) | 3·8 (3·2 – 4·9) |
| Oxygen saturation (SPO2), median (IQR)(n = 274) | 97 (96 - 98) | 97 (95 - 98) |
| Oxygen, No (%) | 125 (89) | 123 (89) |
| Bubble CPAP, No (%) | 5 (4) | 2 (1) |
| IV antibiotics,g No (%) | 123 (87) | 124/137 (91) |
| IV maintenance fluids, No (%) | 125 (89) | 115 (83) |
| IV vitamin K prophylaxis, No (%) | 117 (83) | 111 (80) |
| Apnoea of prematurity prophylaxis (IV caffeine or aminophylline), No (%) | 74 (52) | 57(41) |
a. The start of intervention/control procedures was defined as when a trial pulse oximeter was attached to the neonate, immediately after allocation yet prior to any intervention procedures commencing.
b. Categories of admission weights as per weight cut offs used for stratification during randomisation.
c. Resuscitation at delivery with one or more of: oxygen, bag-valve-mask ventilation or chest compressions.
d. Perinatal septic risk factors included: maternal fever; maternal chorioamnionitis; offensive smelling liquor; prolonged rupture of membranes >18 h.
e. Stability definitions as per published protocol18 and as shown in Fig. 1.
f. Stable and severely unstable neonates were excluded during the screening phase but some eligible neonates improved or deteriorated during the consent and recruitment process, hence were stable or severely unstable when re-assessed at the start of intervention/control procedures.
g. Blood cultures were not obtained prior to antibiotic administration as they were not routinely available as part of standard care at the trial site.
Abbreviations: CPAP = Continuous positive airway pressure; EFSTH= Edward Francis Small Teaching Hospital; g=grams; h = hours; IQR = Interquartile range; IV = Intravenous; SD = standard deviation; SPO2 = oxygen saturation.