Thiamine Responsive Disorders (TRD) Among Infants in Lao PDR (NCT03626337) | Clinical Trial Compass
CompletedNot Applicable
Thiamine Responsive Disorders (TRD) Among Infants in Lao PDR
Laos1,394 participantsStarted 2019-06-17
Plain-language summary
A hospital- and community-based study in Luang Prabang, Lao PDR, which will include a group of hospitalized children 21 days to \<18 months of age who are diagnosed with symptoms compatible with thiamine deficiency disorder (TDD). Based on the infants' response to thiamine administration, children will be defined as either thiamine responsive disorder (TRD) cases or non-responders. A community-based comparison group of infants in the same age range will be included in the study to serve as a control group for identification of potential risk factors.
Who can participate
Age range
21 Days – 17 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria of hospital-based children:
* 21 days to \<18 months and seeking care at the collaborating hospital and meeting at least one of the following inclusion criteria:
* Liver enlargement (\>2 cm below right costal margin on calm, supine exam)
* Edema
* Tachypnea (\> 60/min for 3-8 wks; \>50/min for 2-11 mo; \>40/min for 12 - 18 mo)
* Tachycardia (heart rate \>160/min for \<12 mo; \>120/min for 12 mo - 18 mo)
* Oxygen saturation (\<92%)
* Difficulty breathing (i.e. chest in-drawing, nasal flaring)
* Refusal to breastfeed or refusal of infant formula or food for greater than 24 hours
* Repetitive or recurring vomiting with no obvious other cause(i.e. vomiting \>3 times in past 24 hours)
* Persistent crying not relieved by soothing and feeding with no obvious other cause
* Hoarse voice/cry or loss of voice
* Nystagmus or other unusual eye movement
* Muscle twitching
* Loss of consciousness
* Convulsion
* Opisthotonus / abnormal posturing
* Acute paralysis / flaccid paralysis
Exclusion criteria of hospital-based children:
\- None
Inclusion criteria of community-based children, who will be frequency-matched based on sex, age and residence to hospital-based participants :
* Children aged 21 days to \<18 months
* Residing in selected communities
Exclusion criteria of community-based children:
\- Severe acute illness warranting immediate hospital referral
Inclusion criteria of participants' mothers:
\- Mother of hospital-based study participant or community-bas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.