Dynamics of the Microbiome in the Premature Infant
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | April 2016 |
| Contact: | Kimberley A Fisher, PhD |
| Email: | kimberley.fisher@duke.edu |
| Phone: | 919-681-4913 |
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.
infant as a means to adapt the premature infant gut to affect better health outcomes.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
