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. 2016 Sep 20;2016(9):CD009720. doi: 10.1002/14651858.CD009720.pub2

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
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
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.
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:
  • Sucking pressure

  • Time (days) taken to attain exclusive oral feeding

  • Number of bottle feeds per day and quantity of milk (percentage) ingested per day

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.