Dsilna 2005.
Methods | Blindness of randomisation ‐ Yes. Blindness of intervention ‐ No. Complete follow‐up ‐ No. Blinding of outcome measurements ‐ for outcome of necrotizing enterocolitis only. | |
Participants | 70 infants randomised.
2 post‐randomisation exclusion. 68 infants analysed. Inclusion: gestational age 24 to 29 weeks and birth weight < 1200 grams, stable respiratory status (i.e., arterial‐alveolar oxygen tension ratio >= 0.18), no major congenital malformations, maternal ability to read in Swedish, and residing within geographical catchment area of 3 independent neonatal units at Karolinska University Hospital. |
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Interventions | Feeding initiated before 30 hours postnatal age. Actual not stated. Feeds: mother's own milk or frozen pasturized human milk from the local milk bank. Continuous feedings by electric infusion pump and intermittent orogastric or nasogastric feedings given every third hour over a period of 15 to 40 minutes. Duration of feeding based on volume given and feeding difficulties experienced by infant. Protocol, based on infant's birth weight, followed for increasing feedings. At postmenstrual age of 32 weeks continuous nasogastric feedings weaned to intermittent feeding. Feeding intolerance managed by "clinical routine" which included reducing volume of feeding or temporarily withholding feeding. Fortification of human milk was initiated for all infants when total parenteral nutrition was discontinued. |
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Outcomes | Primary: Days to achieve full enteral feedings. Secondary: Time to regain birth weight, anthropometric measurements, enteral intolerance, necrotizing enterocolitis, and septicaemia. |
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Notes | Infants in the continuous feeding method group compared with infants from the 2 control groups (intermittent orogastric group and intermittent nasogastric group) combined as the two control groups did not "differ in primary outcome, demographic and birth‐related factors, and duration of feedings" (p. 45).
No significant difference in protein and energy intakes. Sample size calculation based on 40% difference in time to achieving full enteral feedings. Did not exclude SGA infants. Exclusions ‐ 2 post‐randomisation because of diagnosed malformations. Switched intermittent orogastric feeding to continuous nasogastric feeding for 14 days (N=1). Switched intermittent orogastric feeding to intermittent nasogastric feeding for 13 days (N=1). Switched intermittent nasogastric feeding to intermittent orogastric feeding for 6 days (N=1). (Not clear if intention‐to‐treat). Mortality ‐ one infant in each feeding group (total 3) died in the early intervention phase due to respiratory and circulatory collapse (not accounted for in sample of the study). Two infants died after postmenstrual ages of 33 and 47 weeks due to septicaemia combined with sever respiratory and circulatory distress and chronic lung disease. Both infants were in the continuous nasogastric feeding group (accounted for in the sample of the study). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Randomised ‐ do not indicate what method was used (e.g., random number table; however, used sealed opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Caregivers not blinded as would not be feasible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Only radiographic assessors for the outcome of NEC were blinded to patient group assignment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Excluded two infants post randomisation because of diagnosed malformations. One infant in the control group was switched to the continuous feeding method group because of severe apnoea and bradycardia secondary to gastroesophageal reflux. Data for this infant was included as randomised. In the early intervention phase, three infants died (one infant in each feeding group) due to respiratory and circulatory collapse. Two infants in the continuous feeding method group died at postmenstrual ages of 33 and 47 weeks secondary to septicaemia and severe respiratory and circulatory distress and chronic lung disease. |