Mattes 1996.
Methods | Parallel‐group randomised controlled trial | |
Participants |
Participants: 42 preterm infants Mean birth weight: 1321 grams in the control group and 1377 grams in the NNS group Mean gestational age: 30.5 weeks in the control group and 31.1 weeks in the NNS group Mean postnatal age: postconceptual age 33.7 weeks in the control group and 33.6 weeks in the NNS group Setting: NICU from across 4 general hospitals, USA Inclusion criteria: body weight greater than or equal to 1250 grams, gestational age < 34 weeks, growth parameters appropriate for gestational age, Apgar scores greater than 3 at 1 minute and greater than 5 at 5 minutes, no clinical evidence of seizure activity, grade 3 or 4 intraventricular haemorrhages, congential heart disease other than patent ductus arteriosus or peripheral pulmonic stenosis that was haemodynamically significant, respiratory distress syndrome Exclusion criteria: presence or signs of necrotizing enterocolitis, hepatic disorder, congenital infection, metabolic disease or anomalies affecting the central nervous system or gastrointestinal tract; infants with parents or guardians who were concerned that exposure could adversely influence future feeding or pacifier preference |
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Interventions |
Experimental group 1: infants were provided with a sweetened edible pacifier for a 4 minute trial followed by a 1 minute rest and another 4 minute trial with a latex pacifier Experimental group 2: infants in the control group received their pacifiers in the reverse order. Infants were initially provided with a latex pacifier for 4 minutes, followed by a 1 minute rest, and a 4 minute trial with a sucrose flavoured pacifier. Sucking was stimulated only at the beginning of the trial by moving the pacifier in and out of the mouth 3 times. Control: no NNS. Maternal heart beat played during tube feeds Data reported for experimental group 2 and control (n = 28) |
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Outcomes | Anthropometric measurements
Sucking measures
Age at full oral feeds Sucking measures were evaluated weekly before a midday feeding. Sucking related pressures on the pacifier were translated through a pressure transducer into audio signals via a modified stereo cassette tape deck and recorded. Frequency and strength were used to assess sucking performance |
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Notes | Latex pacifier group used as experimental group for analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised: "All infants meeting stipulated criteria were recruited at four participating hospitals." 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 ‐ noBlinding 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 |