Saeidi 2013.
Methods | Study design: randomised controlled trial of kangaroo care vs conventional care Location: Iran Setting: recruitment at Sheikh Children Hospital Clinic but intervention applied at home | |
Participants |
Sample size: 70 infants
Number of dropouts/withdrawals: 22 infants
Mean age: 7.2 weeks (SD = 2.3)
Inclusion criteria:
Exclusion criteria Infant:
Mother:
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Interventions | Intervention group (n = 25): parents instructed to provide kangaroo care for 2 hours a day Control group (n = 23): parents asked to "shaking the baby in the crib" (quote). No further clarification was given on this, although the authors do clearly elicit in their discussion that this standard care was in no way comparable to other forms of shaking that the word may infer. So as not to confuse readers, we use the word 'rocking' (or 'rock') in the text. Duration of intervention: 9 days | |
Outcomes |
Primary outcome: crying time
The difference was statistically significant (P < 0.05). Secondary outcome: infant sleep, measured by parental diaries.
The difference in sleep duration when comparing the kangaroo group to the control group over 7 days of treatment was significant (P = 0.02). No standard deviation values were provided. |
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Notes |
Study start date: May 2008
Study end date: May 2009
Declared DOI: none stated
Perceived DOI: none perceived
Funding source: none stated Other comments: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: states participants were randomised but does not describe how this was done and no response from request from author |
Allocation concealment (selection bias) | Unclear risk | Comment: not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: researcher aware of personnel in each study arm |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: parents recorded crying times in diaries |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 22 (out of 70) infants dropped out and were excluded from analysis. Reasons for dropout included mothers being unwell, being too busy or "difficulty in regularly completing the diaries" (quote) |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported |
Other bias | Low risk | Comment: none apparent |