Table 3.
Primary and secondary outcomes in randomized infants
| Immediate Kangaroo Mother Care (1609 assigned) | Control (1602 assigned) | Adjusted RR (95%CI)* | P | |
|---|---|---|---|---|
| Primary outcomes | ||||
| Death between enrolment and 28 days of age, n (%) | 191/1596 (12.0%) | 249/1587 (15.7%) | 0.75 (0.64–0.89) | 0.001 |
| Death between enrolment and 72hr of age, n (%) | 74/1606 (4.6%) | 92/1599 (5.8%) | 0.77 (0.58–1.04) | 0.09 |
| Secondary outcomes † | ||||
| Exclusive breastfeeding at the end of neonatal period, n (%) | 1208/1401 (86.2%) | 1140/1336 (85.3%) | 1.01 (0.98–1.05) | |
| Fully breastfed (only by suckling) at hospital discharge, n (%) | 62/1435 (4.3%) | 55/1376 (4.0%) | 1.06 (0.73–1.53) | |
| Hypothermia, n (%)1 | 90/1609 (5.6%) | 133/1602 (8.3%) | 0.65 (0.51–0.83) | |
| Time to clinical stabilization in hr, median (IQR) 2 | 73.8 (26.8;138.5) (n=1609) | 74.8 (25.3;140.6) (n=1602) | 0.98 (0.90; 1.07) § | |
| Suspected sepsis, n (%) 3 | 361/1575 (22.9%) | 434/1561 (27.8%) | 0.82 (0.73–0.93) | |
| Hypoglycemia at any time between 0–36h of age, n (%)4 | 82/799 (10.3%) | 66/651 (10.1%) | 1.15 (0.85–1.56) | |
| Duration of hospital stay in days, mean (SD)5 | 14.9 (0.2) (n=1609) | 15.2 (0.2) (n=1602) | 1.07 (0.99;1.16) § | |
| Maternal satisfaction with health care in the hospital, mean (SD)6 | 9.2 (1.0) (n=1282) | 9.1 (1.2) (n=1233) | 0.11 (0.03–0.19) ¥ | |
| Maternal depression, n (%)7 | 2/1276 (0.2%) | 7/1231 (0.6%) | 0.23 (0.05–1.14) |
Any instance of axillary temperature <36ºC at any time from 2 hours after randomization until discharge from hospital.
First time at which the infant had all signs of clinical stability: no need for CPAP, no episodes of apnea, SpO2>90, Respiratory rate 40 to < 60, Heart rate 80 to < 180 bpm, Temperature between 36 to 37.4ºC, and no need for IV fluids.
Suspected sepsis defined as one or more of the following signs/symptoms: temperature<35.5ºC or > 38ºC, no movement or movement only on stimulation, chest indrawing, convulsions. For all the signs/symptoms, we removed the first 24 hours, after that time the child should have been well for at least 24 hours before becoming sick. Denominator excludes infants that died, LAMA or were discharged before 48 hours of age.
Hypoglycemia defined as blood sugar < 45 m/dl or < 2.6 mmol/L measured when clinically indicated
Duration of hospital stay was a pre-specified process outcome
Maternal satisfaction with health care in the hospital was collected at discharge on a score of 1 to 10. Higher score implies higher satisfaction
Maternal depression defined as a score of >15 points on Patient Health Questionnaire 9
adjusted for clustering due to multiple births, site, delivery mode, multiple pregnancy, age at randomization, infant’s sex, infant’s weight, mother's years of schooling, maternal age, households with toilet in the house, and family income.
The 95% confidence intervals for secondary outcomes are not adjusted for multiplicity and should not be used to infer definitive intervention effects.
Hazard ratio
Mean difference