Court asked to stop oxygen clinical trials on children

The coast-trials are investigating the best oxygen delivery strategies to reduce mortality and morbidity in African children with respiratory distress complicated by hypoxia in hospital. File photo

What you need to know:

  • The procedure is done by evaluating two link components of oxygen delivery to establish whether liberal oxygenation is superior to permissive hypoxia and to establish whether high flow oxygen delivery is better than low flow oxygen delivery.

Three civil society organisations (CSOs) have petitioned the High Court in Kampala seeking to stop the ongoing clinical oxygen trials on children with respiratory distress.

Center for Health, Human Rights and Development, Community Health and Information Network and Uganda Alliance of Patients Organisation, in their law suit that was filed yesterday, state that the ongoing clinical trials infringe on the children’s fundamental rights to life as enshrined in the Constitution.

Court documents state that in the clinical trial, children are randomly subjected to two strata where those in stratum one are subjected to high flow oxygen and those in second are subjected to low flow oxygen, acts the CSOs say is endangering their lives.

The petitioners contend that in 2016, the Uganda National Health Research Organisation and the Uganda National Council for Science and Technology approved the oxygen trials (Coast-trial) headed by Prof Sarah Kiguli. The research is being carried out on children between 28 days and 12 years admitted to hospital with respiratory distress.

The petitioners aver that despite raising concerns about the efficacy of the trials, particularly about the low flow oxygen arm and the permissive hypoxia arm where the study participants were given no oxygen at all, no action has been taken.

“The third respondent (Prof Kiguli) started conducting this clinical trial without first obtaining a certificate of approval from the National Drug Authority (NDA), which is a requirement prior to conducting any clinical trial on pharmaceuticals in Uganda of which oxygen is listed as a pharmaceutical,” reads in part the court documents.

Court documents also aver that the children under the clinical trials were denied care for life threatening diagnosis that presented with the respiratory difficulties and they only treated the respiratory challenges, which was detrimental to their health and lowered their chances of getting better.

The coast-trials are investigating the best oxygen delivery strategies to reduce mortality and morbidity in African children with respiratory distress complicated by hypoxia in hospital.

The procedure is done by evaluating two link components of oxygen delivery to establish whether liberal oxygenation is superior to permissive hypoxia and to establish whether high flow oxygen delivery is better than low flow oxygen delivery.

Demand

Petition. The petitioners want court to issue an order against the Uganda Medical and Dental Practitioners Council to investigate and file a report to court and parties within one year from the date of judgment on the full effects of the ongoing oxygen clinical trials on each of the tested children and make recommendations on redress for them.
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