Liu C 2001 0 to 2 months.
Methods | Design: randomised controlled trial. Setting: China, community (specialised massage clinic and at home). |
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Participants | Sample sizes: n = 232; intervention n = 159; control n = 73. Ages: not stated, 0‐2 months. Gender: not stated. |
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Interventions | Massage 2 ‐3 times daily for 15 mins for at least 3 months (medium‐term duration of intervention). Massage method by Johnson and Johnson. Carried out by parents who were first trained by doctors at a specialist massage centre. Telephone support and contact from doctors in first month. As touch group but without massage – treatment as usual. Massage provider: mothers trained by researchers. |
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Outcomes | Primary outcome data (Means and SDs): Bayley MDI mental development index, Bayley PDI psychological development index, sleep habits (good, not good, medium), growth (height, weight head circumference, chest circumference) statistical significance only using T and p. Illness (URTI, diarrhoea, anaemia). Timing: outcomes assessed at baseline and at 6 months from start of intervention. |
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Notes | Funder: not stated. If the babies developed anaemia during the studies they were treated with oral iron supplementations until the Hb levels reached normal and then for one month after. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Described in abstract of study as “randomly divided”, but no details given. Comment: judged as high risk, no further details available from trial investigator. |
Allocation concealment (selection bias) | High risk | No apparent attempt to conceal allocation, no details given Comment: judged as high risk, no further details available from trial investigator. |
Incomplete outcome data (attrition bias) All outcomes | High risk | No dropouts reported. Dropouts or losses to follow‐up not addressed in the study report. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded, not possible due to nature of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors. |