Comprehensive Microbiome Survey of Preterm Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Change in Preterm Infant Skin Microbiome
Study Overview
Brief Summary
The skin and intestinal tracts of humans are covered with microbes, and the gene products of these microbes are collectively known as the human microbiome. Many studies in recent years have linked the microbiome to many aspects of human health and disease. Premature infants are vulnerable to invasive infections, some of which may originate from the microbes that colonize the skin and in the intestinal tract. Therefore, determining the patterns of early life colonization and the sources of colonization in these infants may be critical to determining infectious risks. This prospective study is proposed to identify the sources of microbes that colonize extremely low birth weight (ELBW; <1000 g birth weight) infants immediately following birth through the first month of life. The study team plans to non-invasively survey the skin and stool of ELBW preterm infants in combination with sampling of their mothers' skin and stool and the intensive care nursery (ICN) environment. As controls, the study team will perform a similar survey of full term mother-infant pairs. Samples will be analyzed using high throughput sequencing techniques to determine microbial content.
Topical barrier sprays or emollients are commonly used early in life in the ELBW infant to reduce insensible water loss and enhance the integrity of the skin barrier. The effect of these treatments on the development of the skin microbiome remains unknown. As part of this study, the study team also proposes the application of two different skin barrier therapies to small areas on infant's legs to determine the effects of the different treatments on skin colonization. While all parts of the study are described in this summary and the detailed description, the remainder of the record focuses on this interventional portion of the study (Group 2).
The goals of this study are outlined as follows:
- To elucidate the relationship between microbes in the health care environment and colonization patterns of the intestinal tracts in preterm and term infants.
- To understand the relationship between mode of delivery, the health care environment, and the colonization of the skin in preterm and term infants.
- To determine the effects of topical skin barrier therapies on the colonization patterns of the skin in preterm infants.
- To ascertain the relationship between the composition of the microbes colonizing preterm and term infants and the development of mucosal and systemic immunity to those microbes.
Detailed Description
The long term goals of this project are to understand what constitutes protective and beneficial gut and skin microbial communities and determine approaches to foster and preserve these communities. By defining the gut and skin-associated microbiological communities and how these communities are affected by the environment and medical interventions including barrier therapies, the study team will make essential first-steps towards achieving these long term goals.
Design & Procedures Study Groups: Potential subjects will be identified among Duke Hospital-admitted women with expectant preterm (≤30 weeks gestation) or term delivery. A total of 45 infants will be enrolled into one of three groups.
Preterm microbiome Group 1 (n=10, ELBW preterm infants) will be part of an intensive survey of infant colonization with bacteria and fungi in addition to the intensive care environment. This will be a strictly observational group.
Skin microbiome Group 2 (n=30, ELBW preterm infants) will be prospectively evaluated for the development of the skin microbiome in the context of a topical skin therapy typically used in the study nursery. Each infant will serve as his/her own control with a well-circumscribed, small area of the anterior thigh left untreated as the control area.
Full term microbiome Group 3 (n=5, full term infants) will be surveyed for skin and intestinal colonization and serve as a control group. This will be a strictly observational group.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for intervention:
- •Expected live birth, <1000 g birth weight and ≤30 weeks gestation
- •Anticipated caesarian section delivery
Exclusion Criteria
- •Known congenital anomalies on prior prenatal ultrasound
- •Prenatal maternal antibiotics within 48 hours of expected delivery, greater than dosing for surgical prophylaxis
- •Maternal illness:
- •Insulin-dependent diabetes mellitus (gestational or non-pregnancy related)
- •Autoimmune disease including systemic lupus erythematosus
- •Clinical chorioamnionitis (fever, abdominal/pelvic pain, vaginal discharge, and, in women with amniotic membrane rupture, cloudy, foul amniotic fluid)
- •Immunodeficiency (acquired or primary)
Outcomes
Primary Outcomes
Change in Preterm Infant Skin Microbiome
Time Frame: Every day from birth to 14 days of life
The change in the pattern of organisms on the skin over the first 14 days of life.
Secondary Outcomes
- Change in preterm infant neonatal skin condition scores(Daily from birth until 14 days of life)
- Change in Preterm infant skin transepidermal water loss(Every day from birth until 14 days of life)
- Change in preterm skin ph(Daily from birth until 14 days of life)