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 range21 Days – 17 Months
SexALL
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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…