Kanarek 1992.
| Methods | Parallel‐group randomised controlled trial | |
| Participants |
Participants: 21 preterm infants Mean birth weight: 1450 grams in the control group and 1320 grams in the NNS group Mean gestational age: 31.8 weeks in the control group and 31.0 weeks in the NNS group Mean postnatal age: day 1 Setting: neonatal unit NICU, Tampa General Hospital, USA Inclusion criteria: appropriate weight for gestational age, free from major congenital abnormalities, perinatal asphyxia, infection and respiratory distress Exclusion criteria: no other criteria reported |
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| Interventions |
Experimental group: NNS during and after gavage feeding Infants were given a commercial pacifier beginning on the first day of life, during and after all feedings and when they were awake. Blood measurements were taken before and 72 hours after the initiation continuous gavage feedings. In infants who were bolus‐fed, the second specimen was obtained 20 minutes after the feed. Control: no NNS but infants were stroked when restless |
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| Outcomes | Blood specimens:
Specimens were obtained by venepuncture at 08:00‐09:00 just before feeding was initiated. Venepuncture was performed by skilled research nurses, and efforts were made to calm the infants during the procedure to minimize the release of catecholamines. Feedings were then commenced either via bolus (every 3 hours) or continuous feeding via nasogastric tube. For infants who were bolus fed, a second blood specimen was taken 20 minutes after the feed. All other infant had their blood specimens collected 72 hours later. |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "[W]e conducted a controlled, randomized study in healthy premature infants receiving enteral feedings with and without NNS." No further information provided |
| Allocation concealment (selection bias) | Low risk | Blinding of randomisation ‐ yes |
| Blinding (performance bias and detection bias) All outcomes | High risk | Blinding of intervention ‐ no Blinding of outcome assessors ‐ unclear |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up ‐ yes |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not obtained |