Chwo 1999.
Methods | Randomized controlled trial (computerized minimization technique). | |
Participants | 34 healthy late preterm infants 34‐36 weeks' gestation and their mothers. | |
Interventions | 1) SSC group = SSC and on cue self‐regulatory feedings during 6 1‐hour feeding periods beginning M = 21 hours post birth. The infant, in a small diaper, was placed on the ventral surface of their mother's torso. 2) Control group = infants held wrapped in blankets during 6 1‐hour feeding periods beginning M = 23 hours post birth. | |
Outcomes | Infant body weight change day 14 and 28 post birth, length of stay in the hospital, tympanic temperature change and variability, behavioral state inactive awake, drowsy, crying during feedings. | |
Notes | Study was done in a teaching hospital near Taipei, Taiwan. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated minimization process with stratification for gender, birthweight, mode of delivery and parity. |
Allocation concealment (selection bias) | Low risk | Computerised allocation. Not clear how the process was carried out at the point of group allocation. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Women in both the control and intervention did not receive usual care and would likely to have been aware of group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Staff providing care and breastfeeding advice also collected outcome data. This may have had an impact on some outcomes – particularly the observation of infant behavior. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 34 women followed up in hospital by day 14 23 infants available to follow‐up and 26 on day 28. |
Selective reporting (reporting bias) | Unclear risk | Assessment carried out using published study report only. |
Other bias | Unclear risk | The intervention may not be generalizable to other babies in the same study setting. The intervention was described as KC but infants were not in SSC until 4 hours after the birth, then contact was for 1 hour at 4‐hourly intervals at specified feeding times for 6 feeds. Control infants were offered the same contact but babies were in blankets, both groups were given advice and support from the observer. It was not clear how much time infants spent feeding during the observation period. Groups were reported to be similar at baseline. |