Description and Comparison of Biological Vulnerability in Small Vulnerable Newborns Versus Healthy Community Controls in Urban Burkina Faso

NCT05730569 | Recruiting DMC

• 3 other identifiers: ONZ-2022-0500INV-035474 & INV-036154050-2022/CEIRES
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the DenBalo study is to apply integrated multi-omics methods to examine the biological mechanisms underlying this vulnerability in Small Vulnerable Newborns (SVNs) in LMICs, with the ultimate goal of identifying targeted interventions to reduce morbidity and mortality in this high-risk population. The evidence generated from this project will ultimately help promote healthy pregnancies and the birth of healthy babies. To achieve this goal, three research objectives are proposed:

1. 1.To describe and compare gut microbiota, immune system and breastmilk components in SVNs versus healthy community controls in urban Burkina Faso.
2. 2.To describe and compare the development of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.
3. 3.To investigate the relationship between the composition of the gut microbiota, the immune system and breastmilk components during the first six months of life in SVNs versus healthy community controls in urban Burkina Faso.

Conditions

Preterm Birth; Low Birth Weight; Small for Gestational Age at Delivery

Keywords

Preterm Birth; Low Birth Weight; Small for Gestational Age; Small Vulnerable Newborn

Outcome Measures

Primary Outcomes (1)

• Differential abundances of bacterial genera in the infant gut microbiota

  Shotgun metagenomic sequencing

  to be assessed at on days 3, 7, 14, 30, 60, 180 of life

Secondary Outcomes (4)

• Infant gut microbiota α and β diversity

  to be assessed at on days 3, 7, 14, 30, 60, 180 of life

• Infant plasma immunophenotyping

  to be assessed at birth and on days 1, 3, 5, 7, 30, 60 of life

• Infant plasma chemokine and cytokine analyses

  to be assessed at birth and on days 1, 3, 5, 7, 30, 60 of life

• Maternal breastmilk component* profiling

  on days 3, 7, 14, 30, 60 of life

Other Outcomes (21)

• Differential abundance of bacterial populations of pregnant or lactating woman (PLW) fecal microbiota

  to be assessed within 28-30 weeks of gestation, within 33-34 weeks of gestation, on days 7, 14, 30, 60 and 180 of life

• PLW Infant fecal microbiota α and β diversity

  to be assessed within 28-30 weeks of gestation, within 33-34 weeks of gestation, on days 7, 14, 30, 60 and 180 of life

• PLW fecal enteropathogens

  to be assessed within 28-30 weeks of gestation, within 33-34 weeks of gestation, on days 30 and 180 of life

Study Arms (2)

Small Vulnerable Newborns

* Low birth weight: \<2500g; and/or, * Preterm: born between the 34th and 37th week of pregnancy; and/or, * Small for Gestational Age: \<10 percentile of INTERGROWTH-21st birthweight standards.

Healthy Community Controls

* Born after the 37th week of pregnancy; and, * Birth weight ≥2500g; and, * ≥10 percentile of INTERGROWTH-21st birthweight standards.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of all pregnant women at the beginning of the third trimester of their pregnancy attending regular antenatal consultations (ANC) at Accart-Ville, Colma 1 or Farakan health centers.

You may qualify if:

• Fundal height between 24 and 27 cm
• Woman living in the health zone of Accart-Ville, Colma 1 or Farakan
• Woman not planning to give birth or move outside the study area in the first 6 months of the infant's life
• Gestational age between 24 weeks 0 completed day and 29 weeks 6 days (ultrasound)
• Monofetal pregnancy without visible malformation
• Woman agreeing to give her informed consent to participate in the study
• Delivery of a live birth
• Vaginal birth
• Absence of severe infectious pathology, severe pneumopathy or respiratory distress in the neonate
• Neonates who did not receive corticosteroids or antibiotics at birth
• For Small Vulnerable Newborns (SVNs):
• Low birth weight: \<2500g; and/or,
• Preterm: born between the 34th and 37th week of pregnancy; and/or,
• Small for Gestational Age: \<10 percentile of INTERGROWTH-21st birthweight standards.
• For healthy community controls:

You may not qualify if:

• Fundal height \<24 cm or \>27 cm
• Woman living outside the sanitary zone of the Accart-Ville, Colma 1 or Farakan
• Woman planning to give birth outside the study area or to move from it within the first 6 months of the infants's life
• Gestational age \<24 weeks or ≥30 weeks (ultrasound)
• Multi-fetal pregnancy
• Malformation visible on ultrasound
• Cesarean delivery
• Neonate with severe infectious disease, severe pneumopathy or respiratory distress
• Neonate who received corticosteroids or antibiotics just after birth

Sponsors & Collaborators

• University Ghent: lead
• Institut de Recherche en Sciences de la Santé (IRSS): collaborator
• Université NAZI BONI: collaborator
• Hasselt University: collaborator
• University of Virginia: collaborator
• University Hospital, Ghent: collaborator
• Cedars-Sinai Medical Center: collaborator
• Sapient Bioanalytics: collaborator
• Stanford University: collaborator
• Centre Muraz: collaborator
• University of Manitoba: collaborator
• Manitoba Interdisciplinary Lactation Center (MILC): collaborator
• Agence de Formation, de Recherche & d'Expertise en Santé pour l'Afrique (AFRICSanté): collaborator

Study Sites (1)

Agence de Formation, de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté)

Bobo-Dioulasso, Burkina Faso

RECRUITING

Related Publications (17)

• Bennike TB, Fatou B, Angelidou A, Diray-Arce J, Falsafi R, Ford R, Gill EE, van Haren SD, Idoko OT, Lee AH, Ben-Othman R, Pomat WS, Shannon CP, Smolen KK, Tebbutt SJ, Ozonoff A, Richmond PC, van den Biggelaar AHJ, Hancock REW, Kampmann B, Kollmann TR, Levy O, Steen H. Preparing for Life: Plasma Proteome Changes and Immune System Development During the First Week of Human Life. Front Immunol. 2020 Oct 20;11:578505. doi: 10.3389/fimmu.2020.578505. eCollection 2020.

  PMID: 33329546 BACKGROUND

• Bhutta ZA, Black RE. Global maternal, newborn, and child health--so near and yet so far. N Engl J Med. 2013 Dec 5;369(23):2226-35. doi: 10.1056/NEJMra1111853. No abstract available.

  PMID: 24304052 BACKGROUND

• Bittinger K, Zhao C, Li Y, Ford E, Friedman ES, Ni J, Kulkarni CV, Cai J, Tian Y, Liu Q, Patterson AD, Sarkar D, Chan SHJ, Maranas C, Saha-Shah A, Lund P, Garcia BA, Mattei LM, Gerber JS, Elovitz MA, Kelly A, DeRusso P, Kim D, Hofstaedter CE, Goulian M, Li H, Bushman FD, Zemel BS, Wu GD. Bacterial colonization reprograms the neonatal gut metabolome. Nat Microbiol. 2020 Jun;5(6):838-847. doi: 10.1038/s41564-020-0694-0. Epub 2020 Apr 13.

  PMID: 32284564 BACKGROUND

• Bode L. Human milk oligosaccharides: every baby needs a sugar mama. Glycobiology. 2012 Sep;22(9):1147-62. doi: 10.1093/glycob/cws074. Epub 2012 Apr 18.

  PMID: 22513036 BACKGROUND

• Chu H, Mazmanian SK. Innate immune recognition of the microbiota promotes host-microbial symbiosis. Nat Immunol. 2013 Jul;14(7):668-75. doi: 10.1038/ni.2635.

  PMID: 23778794 BACKGROUND

• Funkhouser LJ, Bordenstein SR. Mom knows best: the universality of maternal microbial transmission. PLoS Biol. 2013;11(8):e1001631. doi: 10.1371/journal.pbio.1001631. Epub 2013 Aug 20.

  PMID: 23976878 BACKGROUND

• Granger CL, Embleton ND, Palmer JM, Lamb CA, Berrington JE, Stewart CJ. Maternal breastmilk, infant gut microbiome and the impact on preterm infant health. Acta Paediatr. 2021 Feb;110(2):450-457. doi: 10.1111/apa.15534. Epub 2020 Sep 16.

  PMID: 33245565 BACKGROUND

• Jost T, Lacroix C, Braegger CP, Rochat F, Chassard C. Vertical mother-neonate transfer of maternal gut bacteria via breastfeeding. Environ Microbiol. 2014 Sep;16(9):2891-904. doi: 10.1111/1462-2920.12238. Epub 2013 Sep 3.

  PMID: 24033881 BACKGROUND

• Kollmann TR, Kampmann B, Mazmanian SK, Marchant A, Levy O. Protecting the Newborn and Young Infant from Infectious Diseases: Lessons from Immune Ontogeny. Immunity. 2017 Mar 21;46(3):350-363. doi: 10.1016/j.immuni.2017.03.009.

  PMID: 28329702 BACKGROUND

• Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.

  PMID: 30862783 BACKGROUND

• Ma J, Li Z, Zhang W, Zhang C, Zhang Y, Mei H, Zhuo N, Wang H, Wang L, Wu D. Comparison of gut microbiota in exclusively breast-fed and formula-fed babies: a study of 91 term infants. Sci Rep. 2020 Sep 25;10(1):15792. doi: 10.1038/s41598-020-72635-x.

  PMID: 32978424 BACKGROUND

• Makino H, Kushiro A, Ishikawa E, Kubota H, Gawad A, Sakai T, Oishi K, Martin R, Ben-Amor K, Knol J, Tanaka R. Mother-to-infant transmission of intestinal bifidobacterial strains has an impact on the early development of vaginally delivered infant's microbiota. PLoS One. 2013 Nov 14;8(11):e78331. doi: 10.1371/journal.pone.0078331. eCollection 2013.

  PMID: 24244304 BACKGROUND

• Makino H, Kushiro A, Ishikawa E, Muylaert D, Kubota H, Sakai T, Oishi K, Martin R, Ben Amor K, Oozeer R, Knol J, Tanaka R. Transmission of intestinal Bifidobacterium longum subsp. longum strains from mother to infant, determined by multilocus sequencing typing and amplified fragment length polymorphism. Appl Environ Microbiol. 2011 Oct;77(19):6788-93. doi: 10.1128/AEM.05346-11. Epub 2011 Aug 5.

  PMID: 21821739 BACKGROUND

• Melville JM, Moss TJ. The immune consequences of preterm birth. Front Neurosci. 2013 May 21;7:79. doi: 10.3389/fnins.2013.00079. eCollection 2013.

  PMID: 23734091 BACKGROUND

• Mueller NT, Shin H, Pizoni A, Werlang IC, Matte U, Goldani MZ, Goldani HAS, Dominguez-Bello MG. Delivery Mode and the Transition of Pioneering Gut-Microbiota Structure, Composition and Predicted Metabolic Function. Genes (Basel). 2017 Dec 4;8(12):364. doi: 10.3390/genes8120364.

  PMID: 29207565 BACKGROUND

• Nayak S, Welling J, Burd I. Maternal Immunomodulation Therapy for Prevention of Preterm Birth and Prematurity-Related Morbidity: The New Era of Immuno-Perinatology. Curr Pharm Des. 2017;23(40):6125-6131. doi: 10.2174/1381612823666170926102615.

  PMID: 28950816 BACKGROUND

• Underwood MA. Human milk for the premature infant. Pediatr Clin North Am. 2013 Feb;60(1):189-207. doi: 10.1016/j.pcl.2012.09.008. Epub 2012 Oct 18.

  PMID: 23178065 BACKGROUND

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 Officials

• Trenton Dailey-Chwalibóg, MPH, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Carl Lachat, MEng, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trenton Dailey-Chwalibóg, MPH, PhD

CONTACT

+33603233614; Trenton@Dailey-Chwalibog.com

Study Design

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

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 16, 2023
• Study Start: January 9, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be on embargo for a period of 18 months post study implementation.
• Access Criteria: Upon reasonable request.

Locations

BU (1)