Dynamics of the Microbiome in the Premature Infant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-30

Brief Summary

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The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.

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Detailed Description

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The study team will collect samples of blood and stool from preterm infants once a week from the first week of life until 8 weeks after delivery. Blood samples will be collected from left over blood that is being collected for clinical management. No extra blood draws will be done for research purposes only. Samples of leftover breast milk will be collected once weekly from the first week of life until 8 weeks after delivery.

While the baby is in the hospital the study team will collect information about the growth and development as well as events that happen during their intensive care nursery (ICN) hospitalization.

In addition, blood and stool will be collected, as well as information about the growth when the infant returns to the Duke Special Infant Care Clinic for developmental check-ups at 6 and 12 months of age. The blood will be approximately 1 teaspoon (5 milliliters) and will be done at the same time that labs for clinical management are being done.

A single maternal blood sample (approximately 2 teaspoons) and stool sample will be collected after delivery. Information will also be collected from the medical record.

Conditions

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Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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very low birth weight infants

Very low birth weight infants weighing 1500 grams at birth or less

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1500 grams or less at birth
* infants without genetic diseases or gross anomalies
* mother has to be planning on providing breast milk to the infant