Microbiome Survey of Preterm Infants

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:

1. To elucidate the relationship between microbes in the health care environment and colonization patterns of the intestinal tracts in preterm and term infants.
2. To understand the relationship between mode of delivery, the health care environment, and the colonization of the skin in preterm and term infants.
3. To determine the effects of topical skin barrier therapies on the colonization patterns of the skin in preterm infants.
4. 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.

Conditions

• Skin Microbiome

Interventions

DEVICE

NoSting

Each participant with get both interventions. The infant's NoSting treated thigh will be sprayed with NoSting following delivery and again at 7 days of age. A quarter 1.5 x 3 inch silicon patch that is applied to the infant's thighs will be used for data sampling.

Sponsors & Collaborators

• Duke University

  lead OTHER

Principal Investigators

• Debra Brandon, PhD · Duke University

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• United States

Study Locations