Preterm BirthMSP_ExtNCT03104673
Molecular Signature Children
An observational study of Preterm Birth, run by University of Oxford at 1 site in Thailand.
Trial summary
Preterm birth (PTB) occurs before 37 weeks of gestation and is a major cause of neonatal mortality and morbidity. PTB results from heterogeneous influences. One of them is the inherited predisposition of spontaneous PTB, and another is the change in the placental microbial composition as this can cause infections… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- How many people
- 380 participants
- Where
- 1 siteThailand
- Study dates
- 30 Apr 2017to 12 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Signature of Karen and Burmese Children Until Two Years of Age on the Thailand--Myanmar Border: a Study Extension of TMEC 15-062
Preterm birth (PTB) occurs before 37 weeks of gestation and is a major cause of neonatal mortality and morbidity. PTB results from heterogeneous influences. One of them is the inherited predisposition of spontaneous PTB, and another is the change in the placental microbial composition as this can cause infections, which lead to inflammation, a common cause of preterm birth. Interestingly, maternal periodontal disease is an independent risk factor for PTB, low birth weight and fetal growth restriction. Immune responses to infectious events or inflammation as well as genetic predisposition to inherited conditions have successfully been studied by using assessing genetic expression profiling. The molecular signature is sets of genes, proteins, genetic variants or other variables that can be used as markers for a particular phenotype.
Child morbidity from malnutrition resulting in poor growth and stunting remains a major public health issue that affects the local population just like PTB. While risk factors for malnutrition are multifaceted, there is also a hypothesized causal link between early gut microbiome disruption that leads to chronic malnutrition in otherwise healthy infants.
Read more
Molecular signatures including the intestinal microbiome development of preterm infants will be evaluated and compared to the term (≥37 weeks' gestation) counterparts. Moreover, a comprehensive examination of possible factors associated with poor growth and poor motor- and neurodevelopment will be assessed.
In this extension study: The primary goal for the child is to evaluate the perturbation in the development of the genomic profile including intestinal microbial habitat from children in a rural and limited-resource setting from birth to two years of life.
Read the detailed description
Rationale:
The importance of early life epigenetics is now recognized to have direct implications for health in later life and a consistent limitation expressed in peer reviewed publications has been the small sample size of the studies. Rather than establish a separate cohort to study epigenetics in young children in this environment this extension study of TMEC 15-062 (Molecular signature of Karen and Burmese women on the Thailand--Myanmar border) aims to build on the detailed sampling of the mothers to not only identify biomarkers of preterm labor but also to understand high rates of stunting and anaemia in this area, and possibly develop predictive tools or pave new ways for prevention in the future.
Moreover, a non-invasive intervention in the form of nutrition and WASH counselling may provide information on whether this form of engagement can positively influence child development, prevent malnutrition and whether perturbations in the infants molecular signature can be observed.
In addition, the mothers exposed to the sampling procedure at birth in this study will be able to make a well-informed decision about whether they wish to enrol the child in such a study.
The rationale for the planned samples in children born to mothers who participated in the TMEC 15-062 study are summarized in the following text:
Child gut microbiome and assessment of nutrition from stool samples (Risk-none) The intestinal ecosystem is very dynamic, especially in the first period of life, as it needs to evolve from scratch, hence investigators want to follow children and analyse stool samples in first 24 month of life. investigators propose to assess what kind of impact the gut microbiome has on the child's growth and development. Since exposure to helminths is common in the study population, children stool samples will also be used to examine for helminthic infestations.
This point would also include a home visit as part of nutrition evaluation by questionnaire and direct observation (food preparation including hygiene, child food content, feeding patterns) to relate to microbiome.
Early childhood Transcriptome from capillary blood (Risk-minimum) This point will enable us to understand whether preterm infants have different gene expression than their term counterparts and if so, how it evolves in the early period of life. Moreover, specific signals for children at risk for or suffering from malnutrition or stunting resulting from gastrointestinal inflammation or barrier disruption could be picked up. Total blood 0.85 mL in 2 years.
Early childhood detection of anaemia from capillary blood (Risk-minimum) Anaemia will be treated and iron supplement effect on gut microbiome analysed. Total blood 0.85 mL in 2 years.
Early childhood detection of soil transmitted helminth infection from stool sample (Risk-none) Helminth infection will be treated and the effect on gut microbiome analysed. Stool sample each visit.
Child growth assessment and evaluation of motor and neurocognitive development (Risk-none) Premature infants have a higher risk for lifelong health and development problems. Investigators propose to follow the children's over the period of 2 years to assess their growth and their neurocognitive and motor development. Preterm children's growth and development will be compared to term neonates. The recommended schedule of growth assessment in healthy children is (1, 2, 4, 6, 9, 12, 18, 24 months). In this study children will be followed more frequently: monthly in the first year of life and 3 monthly in the 2nd year of life (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24 months). The reasons for this include: the objective of the root study TMEC 15-062 which is on preterm infants who require closer follow up, to relate perturbations of biomarkers to stunting, and in this mobile population scheduled visits may be missed so a more flexible arrangement for checking anthropometry at any monthly visit in the first year of life reduces the chance that poor growth is not identified.
In addition, the growth and development of children born to mothers who had a febrile episode during pregnancy will be compared to children whose mothers did not experience fever episodes during pregnancy.
Children with poor growth or malnutrition will be given supplementary nutrition and nutrition advice will be given to the mother.
This study was funded by Sidra Medical and Research. Grant reference number: B9R01250
- Conditions
- Preterm Birth
- Keywords
- Molecular signature, Thailand-Myanmar border
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the molecular signature of child
Early childhood Transcriptome from capillary blood
Measured: at birth
Characterization of the molecular signature of child
Early childhood Transcriptome from capillary blood
Measured: 1 year
Characterization of the molecular signature of child
Early childhood Transcriptome from capillary blood
Measured: 2 years
Proportions of nutrition and water, sanitation and hygiene (WASH) behaviours in home-based compared to clinic-based care
Measured: 9 months
Secondary outcomes (4)
Proportion of children with biomarkers perturbations associated with poor child growth
Describe the biomarkers predictive
Measured: From birth to two years of life.
Proportion of children with biomarkers perturbations associated with neurocognitive and motor development
Describe the biomarkers predictive
Measured: From birth to two years of life.
Proportion of children with biomarkers perturbations associated with anaemia
Describe the biomarkers predictive
Measured: From birth to two years of life.
Association between nutrition and water, sanitation and hygiene (WASH) behaviours and biomarker signature perturbations in children
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start30 Apr 2017
- Primary completion28 Jan 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Sidra Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104673
- Sponsor's protocol ID
- SMRU1502 Ext
- Acronym
- MSP_Ext
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2017
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Volunteer's data and results from blood analyses stored in our database may be shared with other researchers to use in the future. However, the other researchers will not be given any information that could identify the subject.
Publications
Singh P, Al Mohannadi N, Murugesan S, Almarzooqi F, Kabeer BSA, Marr AK, Kino T, Brummaier T, Terranegra A, McGready R, Nosten F, Chaussabel D, Al Khodor S. Unveiling the dynamics of the breast milk microbiome: impact of lactation stage and gestational age. J Transl Med. 2023 Nov 6;21(1):784. doi: 10.1186/s12967-023-04656-9.
PubMed 37932773
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Signature of Karen and Burmese Children Until Two Years of Age on the Thailand--Myanmar Border: a Study Extension of TMEC 15-062
- ClinicalTrials.gov ID
- NCT03104673
- Acronym / sponsor ID
- MSP_Ext / SMRU1502 Ext
- Conditions
- Preterm Birth
- Keywords
- Molecular signature, Thailand-Myanmar border
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Sidra Medicine
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm birth (PTB) occurs before 37 weeks of gestation and is a major cause of neonatal mortality and morbidity. PTB results from heterogeneous influences. One of them is the inherited predisposition of spontaneous PTB, and another is the change in the placental microbial composition as this can cause infections, which lead to inflammation, a common cause of preterm birth. Interestingly, maternal periodontal disease is an independent risk factor for PTB, low birth weight and fetal growth restriction. Immune responses to infectious events or inflammation as well as genetic predisposition to inherited conditions have successfully been studied by using assessing genetic expression profiling. The molecular signature is sets of genes, proteins, genetic variants or other variables that can be used as markers for a particular phenotype.
Child morbidity from malnutrition resulting in poor growth and stunting remains a major public health issue that affects the local population just like PTB. While risk factors for malnutrition are multifaceted, there is also a hypothesized causal link between early gut microbiome disruption that leads to chronic malnutrition in otherwise healthy infants.
Molecular signatures including the intestinal microbiome development of preterm infants will be evaluated and compared to the term (≥37 weeks' gestation) counterparts. Moreover, a comprehensive examination of possible factors associated with poor growth and poor motor- and neurodevelopment will be assessed.
In this extension study: The primary goal for the child is to evaluate the perturbation in the development of the genomic profile including intestinal microbial habitat from children in a rural and limited-resource setting from birth to two years of life.
Detailed description
Rationale:
The importance of early life epigenetics is now recognized to have direct implications for health in later life and a consistent limitation expressed in peer reviewed publications has been the small sample size of the studies. Rather than establish a separate cohort to study epigenetics in young children in this environment this extension study of TMEC 15-062 (Molecular signature of Karen and Burmese women on the Thailand--Myanmar border) aims to build on the detailed sampling of the mothers to not only identify biomarkers of preterm labor but also to understand high rates of stunting and anaemia in this area, and possibly develop predictive tools or pave new ways for prevention in the future.
Moreover, a non-invasive intervention in the form of nutrition and WASH counselling may provide information on whether this form of engagement can positively influence child development, prevent malnutrition and whether perturbations in the infants molecular signature can be observed.
In addition, the mothers exposed to the sampling procedure at birth in this study will be able to make a well-informed decision about whether they wish to enrol the child in such a study.
The rationale for the planned samples in children born to mothers who participated in the TMEC 15-062 study are summarized in the following text:
Child gut microbiome and assessment of nutrition from stool samples (Risk-none) The intestinal ecosystem is very dynamic, especially in the first period of life, as it needs to evolve from scratch, hence investigators want to follow children and analyse stool samples in first 24 month of life. investigators propose to assess what kind of impact the gut microbiome has on the child's growth and development. Since exposure to helminths is common in the study population, children stool samples will also be used to examine for helminthic infestations.
This point would also include a home visit as part of nutrition evaluation by questionnaire and direct observation (food preparation including hygiene, child food content, feeding patterns) to relate to microbiome.
Early childhood Transcriptome from capillary blood (Risk-minimum) This point will enable us to understand whether preterm infants have different gene expression than their term counterparts and if so, how it evolves in the early period of life. Moreover, specific signals for children at risk for or suffering from malnutrition or stunting resulting from gastrointestinal inflammation or barrier disruption could be picked up. Total blood 0.85 mL in 2 years.
Early childhood detection of anaemia from capillary blood (Risk-minimum) Anaemia will be treated and iron supplement effect on gut microbiome analysed. Total blood 0.85 mL in 2 years.
Early childhood detection of soil transmitted helminth infection from stool sample (Risk-none) Helminth infection will be treated and the effect on gut microbiome analysed. Stool sample each visit.
Child growth assessment and evaluation of motor and neurocognitive development (Risk-none) Premature infants have a higher risk for lifelong health and development problems. Investigators propose to follow the children's over the period of 2 years to assess their growth and their neurocognitive and motor development. Preterm children's growth and development will be compared to term neonates. The recommended schedule of growth assessment in healthy children is (1, 2, 4, 6, 9, 12, 18, 24 months). In this study children will be followed more frequently: monthly in the first year of life and 3 monthly in the 2nd year of life (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24 months). The reasons for this include: the objective of the root study TMEC 15-062 which is on preterm infants who require closer follow up, to relate perturbations of biomarkers to stunting, and in this mobile population scheduled visits may be missed so a more flexible arrangement for checking anthropometry at any monthly visit in the first year of life reduces the chance that poor growth is not identified.
In addition, the growth and development of children born to mothers who had a febrile episode during pregnancy will be compared to children whose mothers did not experience fever episodes during pregnancy.
Children with poor growth or malnutrition will be given supplementary nutrition and nutrition advice will be given to the mother.
This study was funded by Sidra Medical and Research. Grant reference number: B9R01250
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the molecular signature of child
Time frame: at birth
Early childhood Transcriptome from capillary blood
Characterization of the molecular signature of child
Time frame: 1 year
Early childhood Transcriptome from capillary blood
Characterization of the molecular signature of child
Time frame: 2 years
Early childhood Transcriptome from capillary blood
Proportions of nutrition and water, sanitation and hygiene (WASH) behaviours in home-based compared to clinic-based care
Time frame: 9 months
4 secondary outcomes
Proportion of children with biomarkers perturbations associated with poor child growth
Time frame: From birth to two years of life.
Proportion of children with biomarkers perturbations associated with neurocognitive and motor development
Time frame: From birth to two years of life.
Proportion of children with biomarkers perturbations associated with anaemia
Time frame: From birth to two years of life.
Association between nutrition and water, sanitation and hygiene (WASH) behaviours and biomarker signature perturbations in children
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 37932773Singh P, Al Mohannadi N, Murugesan S, Almarzooqi F, Kabeer BSA, Marr AK, Kino T, Brummaier T, Terranegra A, McGready R, Nosten F, Chaussabel D, Al Khodor S. Unveiling the dynamics of the breast milk microbiome: impact of lactation stage and gestational age. J Transl Med. 2023 Nov 6;21(1):784. doi: 10.1186/s12967-023-04656-9.
- Individual participant dataSharing planned: Yes. Volunteer's data and results from blood analyses stored in our database may be shared with other researchers to use in the future. However, the other researchers will not be given any information that could identify the subject.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the molecular signature of child (time frame: at birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.