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Literature review for - Flourish Paediatrics

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Level of evidence I (aetiology) IV (intervention)<br />

Definition of Not defined<br />

Not defined<br />

breastfeeding<br />

Intervention/<br />

comparator<br />

N<br />

cisapride vs placebo vs non-surgical treatments <strong>for</strong><br />

symptoms of GOR and risk of adverse effects<br />

Trials that measured the risk of adverse events with<br />

cisapride included 190 participants<br />

40° supine body position on infant regurgitation, refluxassociated<br />

symptoms and acid reflux.<br />

30 infants. 52 originally approached (58%)<br />

Population/study<br />

in<strong>for</strong>mation<br />

Trials compared symptoms of<br />

GOR after treatment with cisapride or no treatment<br />

included including 262 participants<br />

Searched databases in 2009 <strong>for</strong> RCTs comparing oral<br />

cisapride therapy with placebo or other non-surgical<br />

treatments <strong>for</strong> children diagnosed<br />

with GOR. (excluded trials in which majority of subjects<br />

were less than 28 days of age)<br />

Ten trials met the inclusion criteria.<br />

Eight trials compared symptoms of GOR after treatment<br />

with cisapride or no treatment. One study compared<br />

cisapride with two dietary interventions, carob bean<br />

thickener and corn syrup<br />

Between 2007 and 2008, the MC-AR Bed was proposed to<br />

parents presenting with infants who were referred because of<br />

frequent regurgitation (>4 times/day) of at least 2 weeks<br />

duration, infant distress time related to feeding<br />

Thirty of 52 infants presenting with GOR were evaluated in<br />

the Multicare AR-Bed. The Infant- Gastroesophageal Reflux<br />

Questionnaire-Revised (I-GERQ-R) and an oesophageal pH<br />

monitoring were per<strong>for</strong>med at<br />

inclusion and after 1 week.<br />

Adverse events (principally diarrhoea) were reported in<br />

four trials<br />

Quality P 0<br />

Results<br />

The pooled OR (random-effects model) <strong>for</strong> cisapride 8/30 (27%) infants did not tolerate the<br />

versus placebo <strong>for</strong> ’same or worse’ symptoms versus 40° positioning, and had to be taken out of the study within<br />

’improvement’ based on seven trials was 0.34 (0.10, the first 2 days. In 22/30 (73%) infants<br />

1.19).<br />

the I-GERQ-R and acid reflux decreased significantly with<br />

267

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