Ramanathan 2001.
| Methods | Randomized controlled trial conducted in New Delhi, India | |
| Participants |
Number of infants: 28 Inclusion criteria: infants with birthweight < 1500 g, stable cardiopulmonary status, tolerating enteral feeds, and maintaining temperature in the thermoneutral environment Exclusion criteria: infants whose mothers were unable to come to the nursery because of illness or disability Infant stabilization status at trial entry: stabilized Infant age and weight at trial entry: Median age at initiation of KMC was 11.8 days. Mean birthweight was 1219 ± 186 and 1271 ± 170 g for KMC and control infants, respectively. No data on infant weight at recruitment |
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| Interventions |
KMC group: Infants were kept between the mother's breasts for ≥ 4 hours per day in not more than 3 sittings. The gown covered the baby's trunk and extremities but not the head. When not receiving KMC, infants received standard care under a warmer or incubator (n = 14) Control group: Infants were kept in a warmer or incubator. Mothers were allowed to visit their babies and touch and handle them (n = 14) Breastfeeding guidelines were followed for both groups and lactational counseling was emphasized to ensure breast milk feeding Level of care: NICU of a tertiary care hospital Human resources: doctors and nurses Criteria for infant discharge from the hospital: weight > 1400 g, “adequate” weight gain, gestation over 34 weeks, only on enteral feeds, no intravenous medications, no overt illness, exclusive breastfeeding, and mother confident of taking care of the infant at home Scheme for follow‐up of infants after discharge: unreported |
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| Outcomes | Weight gain, breastfeeding, duration of hospitalization | |
| Notes | No data on percentage of LBW infants who met eligibility criteria. Infants in KMC group required positive‐pressure ventilation, continuous positive airway pressure, and oxygen therapy over greater duration than infants in control group, indicating that these infants were sicker before enrollment | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| 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 | Unclear risk | Unreported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No infants lost to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | Neonatal complications prospectively recorded but not reported |
| Other bias | Low risk | Other biases not identified |