Rocha 2007.
Methods | Country: Brazil RCT |
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Participants | Very low birth weight, healthy, stable preterm infants Experimental group: N = 49, GA 30.5 ± 1.7 weeks, birth weight 1195 ± 221 grams Control group: N = 49, GA 30.2 ± 1.8 weeks, birth weight 1125 ± 221 grams |
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Interventions |
Experimental group: received a stimulation protocol, as per Fucile 2002, plus non‐nutritive sucking that appears to last 15 minutes. Not clear when it took place and under what conditions. It appears that this was continued until the newborn began an exclusively oral diet ‐ for at least 10 days. Control group: received gavage tube diet with a sham procedure for 15 minutes, but this is not described |
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Outcomes |
Other outcomes reported but not addressed by study authors are days of life at introduction to oral feeds, days of life at full oral feeds, days of life at discharge, GA at introduction to initial oral feeds, GA at introduction of full oral feeds and GA at discharge. |
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Notes | No adverse events were recorded or reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | A double‐blind randomised clinical trial was performed. Randomisation was stratified on the basis of gestation age ranges (26 to 28, 28.1 to 30, 30.1 to 32). Newborns were randomised when they reached a full enteral diet (i.e. 100 kcal/kg/d). |
Allocation concealment (selection bias) | Unclear risk | Information was insufficient to permit judgement of 'yes' or 'no'. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Procedures were performed by 3 SLTs, who used a previously standardised method; this is not directly described, but the Fucile 2002 protocol is cited. Therefore, staff could not have been blinded to group allocation. Staff members who measured the weight of newborns were unaware of newborn group status. Researchers had no influence on newborn hospital discharge date. Therefore, some key study personnel were not blinded, but as outcome assessors and some other personnel were blinded, non‐blinding of researchers is unlikely to introduce bias. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The newborn's capacity to begin an oral diet was clinically evaluated 3 times a day by an external experienced SLT blinded to which group the child belonged. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data are reported for all participants. |
Selective reporting (reporting bias) | Low risk | All of the study’s prespecified outcomes and all expected outcomes of interest to the review have been reported. |
Other bias | Unclear risk | This is unclear. |