Kumar 2013.
Study characteristics | ||
Methods | Randomised controlled trial. | |
Participants | Preterm infants of birth weight < 1800 grams and < 35 weeks' gestation, who were receiving ≥ 100 ml/kg/day enteral feeds. Exclusions: Infants receiving supplemental oxygen > 48 hours after birth, infants with major congenital anomalies, intracranial haemorrhage, meningitis or encephalopathy. |
|
Interventions | 1. Massage with sunflower oil four times daily: N = 27 2. Standard care (no massage): N = 25 Intervention applied for up to 28 days. |
|
Outcomes | Growth parameters. Mortality. |
|
Notes | Setting: Neonatal Intensive Care Unit (NICU), LLRM Medical College, Meerut, India (2009 to 2010). Cross‐over contamination was limited by "segregating the two groups in separate NICU rooms". SD for change in length and head circumference imputed from Soriano 2000. Data on invasive infection not available from investigators (May 2014). |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Opaque, sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unmasked parents and caregivers |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unmasked clinicians and investigators |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Near‐complete growth data assessment (3 randomised infants not included because of protocol violation or loss to follow‐up) |
Selective reporting (reporting bias) | Unclear risk | Data on invasive infection not available from investigators |
Other bias | Low risk | No evidence of baseline imbalance |