Can a Child's molecular signature predict growth and development?

NCT ID NCT03104673

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers are following Karen and Burmese children on the Thailand-Myanmar border from birth until age two. They will analyze gene activity from blood samples and the makeup of gut microbes to see how these molecular patterns relate to preterm birth, growth, and development. The study compares children born preterm with those born at full term, and also looks at home environments and nutrition. The goal is to identify early biological markers that could help predict which children may face health challenges.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this research succeeds, it could reveal early markers that predict which children are at risk for poor growth or developmental delays, pointing toward ways to intervene sooner.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The findings may not apply beyond this specific border population, and the molecular patterns may be complex to interpret.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

380 people

The number who actually took part.

Started

Apr 2017

Finished

Feb 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 400 children born from pregnant women who are attending antenatal care (ANC) clinics at Shoklo Malaria Research Unit and enrol into study TMEC 15-062. A subgroup of infants born to mothers with an uneventful pregnancy, normal vaginal clinic birth at term (estimated age of ≥ 37 weeks) will be approached and invited to participate in the randomised component of the trial.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Karen or Burmese pregnant woman in study TMEC 15-062 who are willing to have their offspring (children) comply with all study requirements * Pregnant woman is willing and able to give informed consent for her child to participate in this study Exclusion Criteria: * Children (in the investigators opinion) with any social or physical condition which would make it difficult to comply with study requirements Inclusion Criteria for water, sanitation and hygiene (WASH) radomization * Mother enrolled to MSP (TMEC 15-062) and child enrolled in MSP\_Ext (TMEC 17-008) * Term pregnancy (gestational age ≥37 weeks) * Clinic birth * Normal new-born * Post-partum mother willing to have home visits * Post-partum mother willing and able to give informed consent to participate in this study Exclusion Criteria for water, sanitation and hygiene (WASH) randomization * Lives too far to make home visits feasible * Home situation unstable and likely to move before the child is 9 months old * Social situation that would make it difficult for the mother to comply

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Shoklo Malaria Research Unit

    Tak, Mae Sot, 63110, Thailand

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