Quick-Wee versus bladder stimulation to collect midstream urine from precontinent infants under 1 year of age: a study protocol for a randomised controlled trial (ES.Stimquick.U)
Anne-Laure Hérissé,
Diane Demonchy,
Hervé Haas,
Antoine Tran,
Jean Bréaud,
Anne Rancurel,
Sarah Marchal,
Jade Janicot,
Julie Salicis,
Marco Olla,
Etienne Bérard,
Julie Bernardor,
Chloé Ribet,
Emma Freyssinet,
Dominique Donzeau,
Jonathan Desmontils,
Clara Schori-Fortier,
Eric Fontas
Affiliations
Anne-Laure Hérissé
Service des Urgences Pédiatriques, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, France
Diane Demonchy
Service des Urgences Pédiatriques, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, France
Hervé Haas
Paediatric Emergency Department, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, Provence-Alpes-Côte d`Azur, France
Antoine Tran
Paediatric Emergency Department, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, Provence-Alpes-Côte d`Azur, France
Jean Bréaud
Pediatric Surgery Department, CHU-LENVAL Paediatric Hospitals of Nice, Nice, France
Anne Rancurel
Service des Urgences Pédiatriques, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, France
Sarah Marchal
Service des Urgences Pédiatriques, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, France
Jade Janicot
Service de Pédiatrie, Centre Hospitalier de Grasse, Grasse, France
Julie Salicis
Service des Urgences Pédiatriques, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, France
Marco Olla
Service des Urgences Pédiatriques, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, France
Etienne Bérard
Service de Néphrologie Pédiatrique, Centre Hospitalier Universitaire de Nice, Nice, France
Julie Bernardor
Service de Néphrologie Pédiatrique, Centre Hospitalier Universitaire de Nice, Nice, France
Chloé Ribet
Service des Urgences Pédiatriques, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, France
Emma Freyssinet
Paediatric Emergency Department, Hôpitaux Pédiatriques de Nice CHU-LENVAL, Nice, Provence-Alpes-Côte d`Azur, France
Dominique Donzeau
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice, Nice, Provence-Alpes-Côte d`Azur, France
Jonathan Desmontils
Service de Pédiatrie, Centre Hospitalier de Grasse, Grasse, France
Clara Schori-Fortier
Service de Pédiatrie, Centre Hospitalier d Antibes Juan les Pins, Antibes, France
Introduction Urinary tract infections occur in around 1%–4% of boys and 3%–8% of girls under 2 years old. Diagnosis is difficult because of non-specific symptoms and the risk of urine analysis contamination depending on the sampling method used for precontinent infants. The American Academy of Pediatrics recommend transurethral catheterisation and suprapubic aspiration because of a low contamination rate but these techniques are invasive. On the other hand, while the National Institute for Health and Care Excellence advocate clean catch urine for its minimal invasiveness and acceptable contamination rate, it is difficult to accomplish in precontinent infants. Two recent methods have been described: the Quick-Wee method by Kaufman et al (suprapubic stimulation with cold saline-soaked gauze); and bladder stimulation by Herreros et al then by Tran et al (pubic tapping alternating with lumbar massage). This study aims to compare the effectiveness in collecting midstream urine by bladder stimulation vs the Quick-Wee method in infants under 1 year, before walking.Methods and analysis This study is a multicentre randomised controlled trial of 230 infants under 1 year and before walking who need urine analysis, conducted in four paediatric emergency departments in France. Patients will be randomised into two groups: bladder stimulation and Quick-Wee method.The primary endpoint will be the success rate of voiding at least 2 mL of urine in less than 5 min.Secondary outcomes are the time to collect at least 2 mL of urine, comfort, quality of urine and the risk factors associated with failure of the two techniques.Ethics and dissemination The study protocol was approved by the French national ethic committee (consultative committee of the protection of persons). The results of the study will be published in a peer-reviewed journal.Trial registration number Clinical Trials Registry - NCT04587999.Date and protocol version identifier October 2020, V.1.