Zomer 2015.
| Study characteristics | ||
| Methods | Cluster‐RCT | |
| Participants | 71 daycare centres (36 intervention DCCs, and 35 control) in Rotterdam‐Rijnmond, Gouda and Leiden in the Netherlands Study enrolled 545 children (intervention = 278, control = 267). Inclusion/exclusion criteria: children who attended the DCC at least 2 days a week; were aged between 6 months and 3.5 years at start of the trial; intended to attend the DCC throughout the study period; and if their parents consented, were Dutch‐speaking, and had access to email or regular post. Children were excluded if they had a chronic illness or medication that predisposed them to infection, a sibling taking part in the trial (i.e. 1 child per family could be included), or if they started attending CCC after the beginning of the trial). |
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| Interventions | 4 components:
See Table 4 for details. |
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| Outcomes | Laboratory: none Effectiveness: incidence of respiratory infections in children monitored by parents. The common cold was defined as a blocked or runny nose with at least 1 of the following symptoms: coughing, sneezing, fever, sore throat, or earache. Safety: none planned or reported by the investigators |
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| Notes | The period study conducted: September 2011 to April 2012 Funding: mixed. The Netherlands Organisation for Health Research and Development (ZonMw). Dispensers and refills were sponsored by SCA Hygiene Products, Sweden. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Stratified randomization is performed by assigning each DCC to one of six strata based on size (i.e. small < 46 children per day versus large ≥ 46 children per day) and geographic location (i.e. highly urban versus urban versus slightly/non‐urban). DCCs are assigned to either intervention or control group by means of computer generation with a 1:1 ratio in each of the strata" |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Outcome is subjective. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptoms were reported by parents, no validation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Very few children were excluded or lost to follow‐up (reasons for exclusions provided). |
| Selective reporting (reporting bias) | Low risk | All planned outcomes are reported. However, between published protocol and the paper, secondary outcomes became the primary outcome in the published paper! |
AEs: adverse events AFH: Armed Forces Hospital AGE: acute gastroenteritis ALRI: acute lower respiratory infection ARI: acute respiratory infection ASR: adverse skin reactions A&E: accident and emergency BIPAP: bilevel positive airway pressure CCC: childcare centre CDC: Centers for Disease Control and Prevention CG: control group CHG: chlorhexidine gluconate CI: confidence interval CMF: citric acid: malic acid: sodium lauryl sulphate (a virucidal mixture added to tissue paper) CoV: coronavirus cluster‐RCT: cluster‐randomised controlled trial CRI: clinical respiratory illness CXR: chest X‐ray DCC: daycare centre EG: experimental group FRI: febrile respiratory illness GI: gastrointestinal GTI: gastrointestinal infection GP: general practitioner HCW: healthcare worker HFH: Hanoi French Hospital HH: hand hygiene HR: high risk HSG: hand sanitiser group ICD‐9: International Classification of Disease, 9th Revision, Clinical Modification ICU: intensive care unit ILI: influenza‐like illness IQR: interquartile range IRR: incident rate ratio ITT: intention‐to‐treat LRTI: lower respiratory tract infection LTCF: long‐term care facility MCU: medical convalescent unit MDCK: Madin Darby canine kidney cell line M group: face mask group MH group: face mask and hand hygiene group MS: monkey‐derived cell line N/A: not applicable NAT: nucleic acid testing NH: nursing home NICU: neonatal intensive care unit NOS: Newcastle‐Ottawa Scales NTS: nasal and throat swab OR: odds ratio PCR: polymerase chain reaction PCU: physical conditioning unit POCT: point‐of‐care testing PP: per protocol PPE: personal protective equipment QNAF: Qatar National Research Fund RCT: randomised controlled trial RDS: respiratory distress syndrome RI: respiratory infection RIDT: rapid influenza diagnostic test RNA: ribonucleic acid RR: risk ratio rRT‐PCR: real‐time reverse transcription‐polymerase chain reaction RTI: respiratory tract infection RT‐PCR: reverse‐transcriptase polymerase chain reaction RSV: respiratory syncytial virus RV: rhinovirus SAB: surfactant, allantoin, and benzalkonium chloride SAR: secondary attack rate SARS: severe acute respiratory syndrome SCBU: special care baby unit SD: standard deviation SHEWA‐B: Sanitation, Hygiene Education and Water Supply in Bangladesh SOB: shortness of breath SOPs: standard operating procedures S/S: signs/symptoms SSTI: skin and soft‐tissue infection STH: soil‐transmitted helminth SWG: soap and water group TIDieR: Template for Intervention Description and Replication UHR‐I: ultra high‐risk infection UHR‐S: ultra high‐risk SARS URI: upper respiratory infection URTI: upper respiratory tract infection WBC: white blood cell WHO: World Health Organization