Anderson 1995.
| Study characteristics | ||
| Methods | Randomised trial | |
| Participants | 14 very low birth weight infants (not defined). Dilute formula with double volume (half‐strength) group (n = 6; gestational age 29.2 ± 2 weeks; birth weight 1235 ± 243 g); full‐strength group (n = 8; gestational age 29.5 ± 2 weeks; birth weight 1185 ± 286 g). (Whether these statistics are means and standard deviations is not described in the abstract.) Day of life on which feeding was initiated did not differ between the groups. The ratio of male to female infants was not reported. The proportion of infants that were small for gestational age, or who had central venous catheters was not described |
|
| Interventions | Half‐ versus full‐strength preterm formula. Dilute group received double‐volume, half‐strength 24 kcal Enfamil Premature formula. Full‐strength group received undiluted 24 kcal Enfamil Premature formula. Feeds were given as 3‐hourly bolus feeds. The 2 groups were compared until infants reached an enteral nutrient intake of 80 kcal/kg/day. No further details were provided on the feeding regimen. | |
| Outcomes | Feeding intolerance (abdominal girth increased by > 2 cm and/or residuals > 50% of previous feed), time to reach goal feeds of 80 kcal/kg/day | |
| Notes | Location: Charleston, South Carolina, USA. Reported as a conference abstract only. The study was not published in full as trial investigators could not recruit enough babies who were being fed formula (personal communication). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: blinding of study personnel or participants was not described but is unlikely given the nature of the trial |
| Blinding of outcome assessment (detection bias) Objective outcomes: enteral energy intake, objective measures of feeding intolerance | Unclear risk | Comment: not described but is unlikely given the nature of the trial |
| Blinding of outcome assessment (detection bias) Subjective outcomes: abdominal distention | Unclear risk | Comment: not described but is unlikely given the nature of the trial |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: difficult to assess since trial reported as an abstract only |
| Selective reporting (reporting bias) | High risk | Comment: trial reported as an abstract only. Actual data not given for some outcomes even though outcomes narratively reported |
| Other bias | Unclear risk | Comment: not enough information to assess since trial reported as an abstract only |