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Microbiome Survey of Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01942577
Recruitment Status : Withdrawn
First Posted : September 16, 2013
Last Update Posted : November 3, 2016
Information provided by (Responsible Party):
Duke University

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:

  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.

Condition or disease Intervention/treatment Phase
Skin Microbiome Device: NoSting Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comprehensive Microbiome Survey of Preterm Infants
Study Start Date : September 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
No Intervention: No treatment
Active Comparator: NoSting 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.
Other Name: Skin protectant

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Preterm infant skin transepidermal water loss [ Time Frame: Every day from birth until 14 days of life ]
  2. Change in preterm skin ph [ Time Frame: Daily from birth until 14 days of life ]
  3. Change in preterm infant neonatal skin condition scores [ Time Frame: Daily from birth until 14 days of life ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria for intervention:

  1. Expected live birth, <1000 g birth weight and ≤30 weeks gestation
  2. Anticipated caesarian section delivery

Exclusion Criteria:

  1. Known congenital anomalies on prior prenatal ultrasound
  2. Prenatal maternal antibiotics within 48 hours of expected delivery, greater than dosing for surgical prophylaxis
  3. Maternal illness:

    1. Insulin-dependent diabetes mellitus (gestational or non-pregnancy related)
    2. Autoimmune disease including systemic lupus erythematosus
    3. Clinical chorioamnionitis (fever, abdominal/pelvic pain, vaginal discharge, and, in women with amniotic membrane rupture, cloudy, foul amniotic fluid)
    4. Immunodeficiency (acquired or primary)

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 identifier (NCT number): NCT01942577

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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Debra Brandon, PhD Duke University

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Responsible Party: Duke University Identifier: NCT01942577     History of Changes
Other Study ID Numbers: Pro00045553
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: December 2015

Keywords provided by Duke University:
Skin protectants
Skin microbiome

Additional relevant MeSH terms:
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Protective Agents
Physiological Effects of Drugs