Microbiome Survey of Preterm Infants

NCT01942577 | Withdrawn

• 1 other identifier: Pro00045553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To determine the effects of topical skin barrier therapies on the colonization patterns of the skin in preterm infants.
4. 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

Keywords

NoSting; Skin protectants; Emollients; Skin microbiome

Outcome Measures

Primary Outcomes (1)

• Change in Preterm Infant Skin Microbiome

  The change in the pattern of organisms on the skin over the first 14 days of life.

  Every day from birth to 14 days of life

Secondary Outcomes (3)

• 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

• Change in preterm infant neonatal skin condition scores

  Daily from birth until 14 days of life

Study Arms (2)

No treatment

NO INTERVENTION

NoSting

ACTIVE COMPARATOR

Device: NoSting

Interventions

NoSting DEVICE

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.

Also known as: Skin protectant

NoSting

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Expected live birth, \<1000 g birth weight and ≤30 weeks gestation
• Anticipated caesarian section delivery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Study Officials

• Debra Brandon, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 16, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 3, 2016

Record last verified: 2015-12

Locations

US (1)