Eka Pratiwi 2009.
Methods | Randomized controlled trial conducted in Bali, Indonesia | |
Participants |
Number of infants: 93 Inclusion criteria: infants with birthweight between 1500 and 2250 g, with Apgar score > 6 at 5 minutes, and mother willing to follow study instructions Exclusion criteria: infants with major congenital malformations, cardiopulmonary problems, critical illness (sepsis, necrotizing enterocolitis, intracranial bleeding); twin gestation or complicated pregnancy and/or labor; mothers with history of drug abuse, psychiatric disorders, or cesarean section, or unable to take care of themselves or their babies Infant stabilization status at trial entry: stabilized Infant age and weight at trial entry: Mean birthweight at recruitment was 2034 ± 159 and 1988 ± 176 g for KMC and control infants, respectively. No data on infant age at recruitment. However, researchers mentioned that KMC was started "in the first day or in several hours after birth" |
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Interventions |
KMC group: Infants were kept in close SSC with the mother whilst in vertical position. Specially tailored kangaroo suits were used by mother‐infant pairs to enable SSC. Mean duration of KMC was 10.0 ± 1.8 hours per day (range, 5.3 to 13.5 hours) (n = 48) Control group: Infants were kept in incubators or open cribs in warm rooms (n = 45) Level of care: NICU of a public hospital Human resources: doctors and nurses Criteria for infant discharge from the hospital: unreported Scheme for follow‐up of infants after discharge: unreported |
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Outcomes | Hypothermia, birthweight regain, sepsis, mortality | |
Notes | 37% of LBW infants met eligibility criteria | |
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 | High risk | Unblinded assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One infant (1%) lost to follow‐up; 4 (4.1%) excluded after randomization owing to sepsis |
Selective reporting (reporting bias) | Low risk | All outcomes stated in Methods section adequately reported or explained in Results |
Other bias | High risk | Use of block randomization (block size of 6), which could make possible prediction of future assignments in an unblinded trial when assignments are revealed subsequent to recruitment of the person into the trial |