Summary of findings – early initiated KMC vs late-initiated KMC in preterm or low-birth weight infants
| Summary of findings table 2. Early initiated KMC compared with late initiated KMC in preterm or low birth weight infants | |||||
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Patient or population: preterm or low birth weight infants
Setting: Hospital or community/home Intervention: Early initiated KMC (within 24 hours after birth) Comparison: late initiated KMC (more than 24 hours after birth) | |||||
| Outcomes |
№ of participants
(studies) Follow-up |
Certainty of the evidence
(GRADE) |
Relative effect
(95% CI) | Anticipated absolute effects | |
| Risk with late initiated KMC | Risk difference with early initiated KMC | ||||
| Mortality by 28 days of age | 3693 (3 RCTs) | ⊕⊕⊕⊕ HIGH* | RR 0.77 (0.66 to 0.91) | 156 per 1000 | 36 fewer per 1000 (53 fewer to 14 fewer) |
| Sepsis until 28 days | 3694 (2 RCTs) |
⊕⊕ΟΟ
LOW†‡ | RR 0.85 (0.76 to 0.96) | 249 per 1000 | 37 fewer per 1000 (from 60 fewer to 10 fewer) |
| Exclusive breastfeeding - At discharge | 3464 (3 RCTs) | ⊕⊕⊕Ο MODERATE‡§ | RR 1.12 (1.07 to 1.16) | 688 per 1000 | 83 more per 1000 (from 48 more to 110 more) |
| Exclusive breastfeeding at 28 days of age | 2841 (3 RCTs) | ⊕⊕⊕Ο MODERATE‡§¶ | RR 1.01 (0.98 to 1.04) | 855 per 1000 | nine more per 1000 (from 17 fewer to 34 more) |
| Hypothermia at discharge or by 28 days | 3713 (4 RCTs) | ⊕⊕⊕⊕ HIGH** | RR 0.74 (0.61 to 0.90) | 109 per 1000 | 28 fewer per 1000 (from 42 fewer to 11 fewer) |
| Weight gain at 28 day follow-up (g/d) | 204 (1 RCTs) |
⊕⊕ΟΟ
LOW††‡‡ | – | Mean weight gain at 28 day follow-up was 12.5 g/day | MD 2.2 g/day lower (5.26 lower to 0.86 higher) |
*Though parents and the clinical team were not masked to the intervention, mortality was considered a 'hard' outcome, so the evidence was not downgraded.
†In both studies, the participants and clinicians were not masked to the intervention. Both diagnosed sepsis based on WHO’s PSBI definition and not by culture positivity. Though the outcome assessment was done by an independent team who was unaware of group allocation in the WHO iKMC study (accounting for 95% of weightage), the risk of performance bias by the clinical team and researchers in a subjective outcome like clinical sepsis or PSBI cannot be ruled out.
‡Significant heterogeneity >50%.
§In three studies, participants and the clinical team were masked. Assessment of exclusive or any breastfeeding is prone to bias. However, the outcome assessment in the WHO iKMC study, which contributed to the maximum weightage in the pooled analysis, was done by an independent team not involved in the intervention. The risk of performance bias – by the clinical team or researchers – in breastfeeding outcomes was considered low; hence, the evidence was not downgraded.
¶95% CI overlap no effect (ie, CI includes RR of 1.0), but they also exclude important benefits as well as important harm; so not downgraded.
**All three studies were at low risk of bias. Although parents and clinical team were not masked to the intervention, measurement of temperature is less prone to outcome assessment bias. Hence not downgraded.
††A single study that was prematurely terminated at 75% enrolment. We did not downgrade for lack of masking of caregivers or outcome assessors because weight measurement is an objective outcome.
‡‡95% CI overlaps no effect (ie, CI includes RR of 1.0).
MD, Mean difference; RR, Risk ratio.