Clinical trial NCT02121938: Dynamics of the Microbiome in the Premature Infant
Official title: Dynamics of the Microbiome in the Premature Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Very Low Birth Weight (VLBW)
Microbiome
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very low birth weight infants

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

* infants with genetic diseases or gross anomalies
* parents who are not willing to give consent

Primary outcomes:
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 1
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 2
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 3
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 4
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 5
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 6
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 7
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: Week 8
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: 6 months
measure: antigen identification of the infant microbiome over the first year of life
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke Univeristy
name: Patrick Seed, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: