Candida Infection, Premature Infant
Conditions
Brief summary
This study evaluates whether adding a dietary supplement similar to coconut oil (MCT oil) to feedings in premature infants will reduce the amount of yeast (Candida) detectable in their stool. Infants who have Candida in their stool are eligible to participate. Half of the enrolled infants will have additional MCT oil added to their feedings and half will not.
Interventions
DRUGMedium-Chain Triglyceride (MCT) Oil
Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
Sponsors
Tufts University
Joseph Bliss
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Premature infant admitted to the Neonatal Intensive Care Unit at Women & Infants Hospital * Receiving full enteral feeds of either preterm or transitional formula or fortified breast milk * Anticipated to have a minimum stay of two weeks
Exclusion criteria
* Prior exposure to antifungal drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool Fungal Burden | Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation) | Change in colony-forming units (cfu) of Candida per gram of stool. Data table reflects total number of stool samples collected from subjects in each group that were included in the analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control This group receives no feeding supplement. | 4 |
| MCT Oil This group is supplemented with MCT oil
Medium-Chain Triglyceride (MCT) Oil: Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge. | 8 |
| Total | 12 |
Baseline characteristics
| Characteristic | Control | Total | MCT Oil |
|---|---|---|---|
| Age, Continuous | 27.8 weeks gestation | 26.7 weeks gestation | 25.5 weeks gestation |
| Antacid treatment | 0 Participants | 0 Participants | 0 Participants |
| Antibiotic duration | 4.5 days | 6.3 days | 8.1 days |
| Birth weight | 1032 grams | 889 grams | 745 grams |
| Breast milk feeds | 3 Participants | 8 Participants | 5 Participants |
| Cesarean delivery | 3 Participants | 9 Participants | 6 Participants |
| Formula feeds | 1 Participants | 4 Participants | 3 Participants |
| Maternal age | 29 years STANDARD_DEVIATION 9 | 29 years STANDARD_DEVIATION 10 | 30 years STANDARD_DEVIATION 10 |
| Peripherally inserted central catheter duration | 9.7 days | 8.7 days | 7.6 days |
| Postnatal steroids | 0 Participants | 3 Participants | 3 Participants |
| Prenatal steroids | 3 Participants | 9 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 5 Participants |
| Total parenteral nutrition duration | 15.5 days | 15.8 days | 16 days |
| Umbilical line duration | 4.5 days | 6.1 days | 7.6 days |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 8 |
| other Total, other adverse events | 0 / 4 | 0 / 8 |
| serious Total, serious adverse events | 0 / 4 | 0 / 8 |
Outcome results
Primary
Stool Fungal Burden
Change in colony-forming units (cfu) of Candida per gram of stool. Data table reflects total number of stool samples collected from subjects in each group that were included in the analysis.
Time frame: Before supplementation, 1 week after supplementation begins, 3 weeks (at conclusion of supplementation)
Population: Candida colony counts per gram of stool in each sample
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Stool Fungal Burden | Before supplementation | 500 cfu per gram |
| Control | Stool Fungal Burden | During supplementation | 1671 cfu per gram |
| Control | Stool Fungal Burden | After supplementation | 1744 cfu per gram |
| MCT Oil | Stool Fungal Burden | Before supplementation | 55000 cfu per gram |
| MCT Oil | Stool Fungal Burden | During supplementation | 622.5 cfu per gram |
| MCT Oil | Stool Fungal Burden | After supplementation | 2364 cfu per gram |
Comparison: Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the control group.p-value: 0.995% CI: [0.55, 1.7]Negative binomial regression
Comparison: Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the control group.p-value: <0.00195% CI: [2.6, 25]Negative binomial regression
Comparison: Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the MCT group.p-value: 0.0295% CI: [0.03, 0.75]Negative binomial regression
Comparison: Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the MCT group.p-value: <0.00195% CI: [6.9, 533]Negative binomial regression