Cohen 1999.

Methods	Randomised, double‐blind, placebo‐controlled trial
Participants	Age < 36 months Clinical diagnosis of GOR: frequent V or R often associated with feeding difficulties and/or excessive crying. Baseline 24‐h oesophageal pH monitoring: RI ≥5% OR GOR score (Euler and Byrne) ≥50. Exclusion criteria: anatomic abnormality of the GI tract, previous GI surgery, treatment with anticholinergics, theophylline, other diagnosis which could explain vomiting.
Interventions	2 weeks of either: cisapride suspension (1mg/ml) 0.2 mg/kg qid (n=50*) placebo (n=45*)
Outcomes	Parental evaluation at 2 weeks: overall symptom intensity on VAS 0‐10 cm (0=absence of symptoms, 10= could not be worse) improvement (marked=complete or near complete resolution of symptoms, moderate=partial resolution, minimal=slight improvement, unchanged, deterioration). Evaluation during the 2 weeks of treatment: presence of vomiting, gagging, crying (score 0‐3). AE: any, withdrawals due to AE. Investigator assessment at 2 weeks: 24‐h oesophageal pH oesophagitis at biopsy. Data (means, SD) also obtained for complications of GOR (apnoea, wheezing, nocturnal cough, haematemesis) and weight gain (Davidson 2009).
Notes	68 participants (38, 30) completed the trial. Withdrawn if: consent was withdrawn, serious AE, further investigations necessitated a change in treatment. A high proportion of participants had received prior treatment with: thickened feeds, positional therapy, cisapride, H2 antagonists, antacids, metoclopramide, other.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Further details obtained from one of the trial investigators (GD) by one of the review authors (SM). Randomisation was centrally controlled (outside of the three participating centres), by computer generated code (Davidson 2009).
Allocation concealment?	Low risk	Adequate
Blinding? All outcomes	Unclear risk	"matched placebo (both provided by Janssen Research Foundation, Belgium)" p288. Further details not given.