Kirkwood 2013.
| Methods | Cluster‐randomised trial (NEWHINTs) undertaken in Ghana | |
| Participants | 49 zones were randomly assigned to intervention and 49 to control. From the control arm, n = 10,096 pregnant women were recruited, and n = 9885 pregnant women were recruited from the NEWHINTs zones (intervention). Data analysis included all pregnancies that result in live birth or stillbirth (total of 16,329 deliveries during trial period) | |
| Interventions | Community‐based surveillance volunteers (CBSVs) in intervention zones were trained to identify pregnant women in their community and to counsel and solve problems related to key essential newborn care behaviours. CBSVs were trained to make 2 home visits during pregnancy, and 3 in the first week of life, to promote newborn care practices, to weigh and assess babies for danger signs, and to refer if necessary (n = 8035 eligible deliveries) Control: routine maternal and child health care, including antenatal clinics, access to free fertility delivery, postpartum checkups, infant welfare clinics, and routine CBSV activities.(n = 8294 eligible deliveries) |
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| Outcomes | Primary outcome: all‐cause neonatal mortality rate (all deaths that happen in the first 28 days of life), % of mothers practising the Newhints recommended behaviours Secondary outcomes: age‐specific and cause‐specific neonatal mortality rates |
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| Notes | Funding: WHO; Save the Children’s Saving Newborn Lives Programme from the Bill & Melinda Gates Foundation; and UK Department for International Development provided funding. Funders had no role in data gathering, data analysis, or writing of the report | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated restricted randomisation using stratified sampling (1‐to‐1 ratio) Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Comment: since this is a cluster‐randomised trial, allocation concealment should not be an issue, as in this design, all clusters are randomised at once |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: could not blind community‐based surveillance volunteers as they were trained |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: attrition (4.9%) and reasons were reported |
| Selective reporting (reporting bias) | Low risk | Comment: this is a registered trial, and this study has reported all outcomes mentioned in the protocol |
| Other bias | High risk | Comment: some pregnant women swapped groups (intervention or control) during the trial |