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Molecular Signature Children (MSP_Ext)

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ClinicalTrials.gov Identifier: NCT03104673
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
Sidra Medical and Research Center
Information provided by (Responsible Party):
University of Oxford

Brief 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, 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.


Condition or disease
Preterm Birth

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 30, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019



Primary Outcome Measures :
  1. Characterization of the molecular signature of child [ Time Frame: at birth ]
    Early childhood Transcriptome from capillary blood

  2. Characterization of the molecular signature of child [ Time Frame: 1 year ]
    Early childhood Transcriptome from capillary blood

  3. Characterization of the molecular signature of child [ Time Frame: 2 years ]
    Early childhood Transcriptome from capillary blood

  4. Proportions of nutrition and water, sanitation and hygiene (WASH) behaviours in home-based compared to clinic-based care [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Proportion of children with biomarkers perturbations associated with poor child growth [ Time Frame: From birth to two years of life. ]
    Describe the biomarkers predictive

  2. Proportion of children with biomarkers perturbations associated with neurocognitive and motor development [ Time Frame: From birth to two years of life. ]
    Describe the biomarkers predictive

  3. Proportion of children with biomarkers perturbations associated with anaemia [ Time Frame: From birth to two years of life. ]
    Describe the biomarkers predictive

  4. Association between nutrition and water, sanitation and hygiene (WASH) behaviours and biomarker signature perturbations in children [ Time Frame: 9 months ]

Biospecimen Retention:   Samples With DNA
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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104673


Contacts
Contact: Rose McGready, MD, PhD +(66) 55545021 rose@shoklo-unit.com
Contact: Francois Nosten, MD, PhD +(66) 55545021 francois@tropmedres.ac

Locations
Thailand
Shoklo Malaria Research Unit Recruiting
Tak, Mae Sot, Thailand, 63110
Contact: Rose McGready, MD    +6655-545-021    rose@shoklo-unit.com   
Principal Investigator: Rose McGready, MD         
Sponsors and Collaborators
University of Oxford
Sidra Medical and Research Center

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03104673     History of Changes
Other Study ID Numbers: SMRU1502 Ext
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oxford:
Molecular signature
Thailand-Myanmar border

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications