Molecular Signature Children

NCT03104673 | Completed

• 1 other identifier: SMRU1502 Ext
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Molecular signature; Thailand-Myanmar border

Outcome Measures

Primary Outcomes (4)

• Characterization of the molecular signature of child

  Early childhood Transcriptome from capillary blood

  at birth

• Characterization of the molecular signature of child

  Early childhood Transcriptome from capillary blood

  1 year

• Characterization of the molecular signature of child

  Early childhood Transcriptome from capillary blood

  2 years

• Proportions of nutrition and water, sanitation and hygiene (WASH) behaviours in home-based compared to clinic-based care

  9 months

Secondary Outcomes (4)

• Proportion of children with biomarkers perturbations associated with poor child growth

  From birth to two years of life.

• Proportion of children with biomarkers perturbations associated with neurocognitive and motor development

  From birth to two years of life.

• Proportion of children with biomarkers perturbations associated with anaemia

  From birth to two years of life.

• Association between nutrition and water, sanitation and hygiene (WASH) behaviours and biomarker signature perturbations in children

  9 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Children (in the investigators opinion) with any social or physical condition which would make it difficult to comply with study requirements
• 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
• 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

Sponsors & Collaborators

• University of Oxford: lead
• Sidra Medicine: collaborator

Study Sites (1)

Shoklo Malaria Research Unit

Tak, Mae Sot, 63110, Thailand

Location

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

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: April 7, 2017
• Study Start: April 30, 2017
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)