Johnston 2011.
| Methods | Randomized cross‐over trial | |
| Participants | 62 preterm infants (PMA 28 to 36 weeks) Postnatal age, mean, days: 5 to 10 Birth weight, mean ± SD, grams: 1565 ± 469 (father KC/mother KC); 1610 ± 494 (mother KC/father KC) Painful procedure: heel lance Study period: 16 January 2008 to 24 March 2009 |
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| Interventions | Intervention: 30 minutes of skin‐to‐skin care before and during heel lance provided by mother Comparison: 30 minutes of skin‐to‐skin care before and during heel lance provided by father Provider: mother or father |
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| Outcomes | PIPP score at 30, 60, 90, and 120 minutes, time for HR to return to baseline | |
| Notes | Country: Canada Power calculation: yes |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "When clinical care required blood procurement, the research nurse went to the secure computer Web site for the order assignment that had been generated randomly in permutated blocks of 4 and 6." |
| Allocation concealment (selection bias) | Low risk | "When clinical care required blood procurement, the research nurse went to the secure computer Web site for the order assignment that had been generated randomly in permutated blocks of 4 and 6. The parents were then contacted by the research nurse, informing them of which one was to provide KC for that procedure." |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Close‐up video recordings of the infants' faces were made using a KS162 digital camera at 2 sites and a webcam at the third site." Not clear if mothers' skin/breasts could be noted by researchers |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "...there were 185 infants who were determined to be eligible from 3 university‐affiliated level III neonatal intensive care units. A major reason for not being eligible was the unavailability of the father in the daytime. The refusal rate was 22%, mostly because one or the other parent did not want to do KC or particularly did not want to be videotaped, even though it was explained that the camera would be focused on the infant's face." Unclear of the exact number of participants |
| Selective reporting (reporting bias) | Unclear risk | Primary outcomes were clearly laid out in Table 3 and in the Results section |
| Other bias | Unclear risk | "Intrarater reliability was checked every 3 months, remaining more than 90%. When asked what they thought the study was about, the coders independently stated that it was about facial grimacing when infants were calm or crying." Washout period not described |