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Making co-enrolment feasible for randomised controlled trials in paediatric intensive care
Katie Harron1, Twin Lee, Tracy Ball
1MRC Centre for Epidemiology of Child Health, Institute of Child Health, University College London, London, United Kingdom.
Insights
Co-enrolling children in multiple pediatric intensive care unit (PICU) trials, like the CATCH and CHIP studies, did not hinder recruitment or overwhelm parents. Developing strategies for combined consent information is crucial for future multi-trial research in PICUs.
Area of Science:
- Pediatric Intensive Care
- Clinical Trial Recruitment
- Informed Consent
Background:
- Simultaneous enrollment in multiple clinical trials can expedite research and improve patient care in pediatric intensive care units (PICUs).
- Evaluating clinician and parental decision-making regarding co-enrollment in concurrent trials is essential for optimizing recruitment strategies.
Purpose of the Study:
- To assess clinician and parental decisions on co-enrolling children in two large pragmatic trials within PICUs: the CATCH trial (central venous catheters) and the CHIP trial (hyperglycemia control).
- To determine the impact of co-enrollment on recruitment rates and parental consent in PICU settings.
Main Methods:
- Recorded trial overlap periods and clinician reasons for co-enrollment decisions across participating PICUs.
- Examined parental consent decisions by measuring recruitment rates and reasons for declining participation in co-enrollment scenarios.
Main Results:
- Three of five PICUs with overlapping trials initially declined co-enrollment due to concerns about recruitment, parental burden, and information complexity.
- Two units proceeded with co-enrollment to maximize recruitment; one unit reported consent rates of 82% for CATCH and 51% for CHIP during co-enrollment.
- Co-enrollment did not negatively affect consent rates compared to single-trial enrollment in one unit.
Conclusions:
- Co-enrollment in pediatric intensive care unit trials appears feasible without jeopardizing recruitment or overwhelming parents.
- Development of standardized strategies for obtaining informed consent for multiple concurrent trials is recommended, focusing on clear, combined information delivery.
Aims:
Enrolling children into several trials could increase recruitment and lead to quicker delivery of optimal care in paediatric intensive care units (PICU). We evaluated decisions taken by clinicians and parents in PICU on co-enrolment for two large pragmatic trials: the CATCH trial (CATheters in CHildren) comparing impregnated with standard central venous catheters (CVCs) for reducing bloodstream infection in PICU and the CHIP trial comparing tight versus standard control of hyperglycaemia.
Methods:
We recorded the period of trial overlap for all PICUs taking part in both CATCH and CHiP and reasons why clinicians decided to co-enrol children or not into both studies. We examined parental decisions on co-enrolment by measuring recruitment rates and reasons for declining consent.
Results:
Five PICUs recruited for CATCH and CHiP during the same period (an additional four opened CATCH after having closed CHiP). Of these five, three declined co-enrolment (one of which delayed recruiting elective patients for CATCH whilst CHiP was running), due to concerns about jeopardising CHiP recruitment, asking too much of parents, overwhelming amounts of information to explain to parents for two trials and a policy against co-enrolment. Two units co-enrolled in order to maximise recruitment to both trials. At the first unit, 35 parents were approached for both trials. 17/35 consented to both; 13/35 consented to one trial only; 5/35 declined both. Consent rates during co-enrolment were 29/35 (82%) and 18/35 (51%) for CATCH and CHiP respectively compared with 78% and 51% respectively for those approached for a single trial within this PICU. The second unit did not record data on approaches or refusals, but successfully co-enrolled one child.
Conclusions:
Co-enrolment did not appear to jeopardise recruitment or overwhelm parents. Strategies for seeking consent for multiple trials need to be developed and should include how to combine information for parents and patients.
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