Gill 1992.
| Methods | Parallel‐group randomised controlled trial | |
| Participants |
Participants: 42 preterm infants Mean birth weight: 1254 grams in the control group and 1408 grams in the NNS group Mean gestational age: mean gestational age 29.3 weeks in the control group and 30.2 weeks in the NNS group Mean postnatal age: mean postnatal age 25.9 days in the control group and 22.8 days in the NNS group Setting: neonatal unit in a teaching hospital, USA Inclusion criteria: birth weight < 2000 grams, ≤ 34 weeks gestational age, appropriate weight for gestational age, being fed by gavage, and ready to have a first bottle feeding. Exclusion criteria: no infants had intraventricular haemorrhage grades III or IV or congenital or neurological anomalies |
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| Interventions |
Experimental group: NNS before bottle feeding. The researcher held the commercially made premature‐sized pacifier in the infant's mouth for 10 minutes prior to a scheduled bottle feed over a 2‐3 day period between 6 am and 10 pm Control: no NNS |
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| Outcomes | Behavioral state: Anderson Behavioral State Scale: used to assess behavioral state. The assessment began before disturbing the infant for bottle feeding. Each assessment lasted 30 seconds and the highest behavioral state was recorded. After 5‐minute rest a second behavioral state assessment performed. During these 5 minutes infants in the NNS group received NNS. After this period ended both groups were fed based on the individual infant's weight and age. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised: "The sample consisted of 42 preterm infants who were randomly assigned by pre‐coded envelope." No further information provided |
| Allocation concealment (selection bias) | Low risk | "42 preterm infants who were randomly assigned by pre‐coded envelope." No further information provided |
| Blinding (performance bias and detection bias) All outcomes | High risk | Blinding of intervention ‐ no Blinding of outcome assessors ‐ no |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up ‐ yes |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not obtained |