Toce 1987.
Methods | Quasi‐experimental. Alternate assignment within 16 groups.
Stratified:
<1250g,
1250‐1500g,
sex,
IUGR, and prior need for ventilation. Blindness of randomisation ‐ Can't tell. Blindness of intervention ‐ No. Complete follow‐up ‐ No. Blinding of outcome measurement ‐ Can't tell. |
|
Participants | 83 infants
(obtained consent). 30 excluded (completed less than 7 days). 53 analysed. Inclusion: Preterm infants <= 1500grams, no major congenital anomalies, no longer ventilated, and ready for enteral nutrition. |
|
Interventions | Continuous feeds delivered by infusion pump. Intermittent feeds every 3 hours by gravity. Feeding protocol for infants. Predetermined criteria to manage feeding intolerance (feeds held > 16 hours). Energy intake constant between groups. Feeds: sterile water, initially diluted formula. Timing of Feeds: Protocol was not stated. Actual for Continuous group was 9.7 +/‐ 7.1 days and for Intermittent group was 7.3 +/‐ 4.8 days. | |
Outcomes | Somatic growth (weight, length, head circumference, and skinfold thickness gains), feeding related complications, changes in total protein, bilirubin, and albumin. | |
Notes | Subjective eligibility criteria, no sample size calculation, and not intent‐to‐treat. Definition of feeding intolerance not described. Significant differences in demographic factors between groups: low one‐minute Apgar scores in the Continous group, and increase frequency of human milk feeding in the Intermittent bolus gavage feeding method. Awaiting subgroup data. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | High risk | Quasi‐experimental. Alternate assignment within 16 groups. Stratified: <1250g, 1250‐1500g, sex, IUGR, and prior need for ventilation. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Caregivers not blinded as would not be feasible. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Post‐randomisation exclusion of infants from the analysis resulted in loss to follow‐up. |