Boiron 2007.
Methods | Country: France RCT Four study groups. Randomisation method described Allocation concealment unclear Blinding of personnel delivering the intervention unclear Blinding of outcome assessor unclear |
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Participants | 43 participants were recruited and participated in the study (23 males/20 females); all were born between 29 and less than 34 weeks and entered the protocol at between 32 and less than 34 weeks GA; no older than 4 days of age Treatment group 1 (stimulation and support): 9 participants (5 males/4 females), age range 32 to 34 weeks, mean GA 31.3 weeks, mean birth weight 1718 grams Treatment group 2 (stimulation): 11 participants (4 males/7 females), age range 32 to 24 weeks, mean GA 31.1 weeks, mean birth weight 1446 grams Treatment group 3 (support): 11 participants (7 male/4 female), age range 32 to 34 weeks, mean GA 31.6 weeks, mean birth weight 1714 grams Control group: 11 participants (7 male/4 female), age range 32 to 34 weeks, mean GA 31.1 weeks, mean birth weight 1442 grams |
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Interventions |
Treatment group 1: received oral stimulation and support Treatment group 2: received oral stimulation only Treatment group 3: received support only Control group: no intervention described; assumed standard care Infants in treatment group 1 received 12 minutes of a clearly described oral stimulation protocol 30 minutes before gavage feed for last 14 consecutive days of period of gavage, and oral support for 2 oral feeds a day for a maximum of 10 minutes per bottle during the transition period. Treatment groups 2 and 3 each received only 1 component of this programme. |
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Outcomes | All participants had a baseline sucking assessment with a pacifier and a transducer recording system. Five‐minute recordings were taken at 3, 7 and 14 days. Outcome measures:
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Notes | Adverse events were not reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A blocked randomisation process is described: "randomisation lists were computer generated with blocks of varying size". |
Allocation concealment (selection bias) | Unclear risk | This is not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Investigators were not blinded to intervention groups. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Measures of sucking were made by investigators; it is unclear who decided to increase volume of oral feeding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes are reported. No data were missing. |
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 | High risk | Adverse events were not reported. It is unclear who decided to increase volume of oral feeding as intervention progressed. |