Ghavane 2012.
| Methods | Randomized controlled trial conducted in Hyderabad, India | |
| Participants |
Number of infants: 140 Inclusion criteria: infants with birthweight < 1500 g, tolerating spoon feeds of 150 mL/kg/d, and hemodynamically stable (not receiving oxygen or respiratory support, no apnea for 72 hours, not receiving intravenous fluids) Exclusion criteria: major malformations, refused consent Infant stabilization status at trial entry: stabilized Infant age and weight at trial entry: Mean age at recruitment was 14.1 ± 10.3 and 13.7 ± 10.2 days, and mean weight was 1191 ± 131 and 1223 ± 125 g, for KMC and control infants, respectively |
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| Interventions |
KMC group: Infants were kept in SSC, between the mother's breasts, in an upright position, dressed with a cap, socks, and diaper, and supported at the bottom with a cloth sling/binder, for ≥ 8 hours per day. When not receiving KMC, infants were placed in open cribs (n = 71) Control group: Infants were kept in a warmer or incubator. Mothers were allowed to visit their babies and were encouraged to perform infant care activities such as diaper change, oil massage, and paladai feeding (n = 69) Level of care: "kangaroo ward" (KMC infants) and neonatal intermediate care unit (controls) at a level III tertiary care hospital Human resources: Infants in KMC group were cared for solely by their mothers, assisted by a trained nurse. Infants in control group were cared for by doctors and nurses Criteria for infant discharge from the hospital: (1) For infants in KMC group: weight ≥ 1300 g or weight gain ≥ 10 g/d on 3 consecutive days if weight at randomization was > 1300 g. (2) For infants in control group: weight ≥ 1300 g, weight gain ≥ 10 g/d on 3 consecutive days, and skin temperature of 36°C to 37°C in the servo mode of the incubator with heater output < 25% Scheme for follow‐up of infants after discharge: weekly until 40 weeks' postmenstrual age |
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| Outcomes | At 40 weeks' postmenstrual age: infant growth At discharge: breastfeeding, sepsis, hypothermia, apnea, hypoglycemia, length of hospital stay, mortality |
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| Notes | No data on percentage of LBW infants who met eligibility criteria. Additional data provided by Dr Srinivas Murki | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Web‐based random number generator |
| Allocation concealment (selection bias) | Low risk | Numbered sealed opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Physician who assessed growth outcomes was blinded to infants' intervention group |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 infants (2.9%) lost to follow‐up (KMC 3, control 1); no exclusions |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in Methods section adequately reported or explained in Results |
| Other bias | Low risk | Other biases not identified |