Breastfeeding, Breastfeeding, Exclusive
Conditions
Keywords
Late Preterm, Donor Breast Milk
Brief summary
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.
Detailed description
In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.
Interventions
OTHERDonor Breast Milk
Donor breast milk will be given to the newborn if supplementation is required
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age \>34 weeks and 0 days * Mother's intent to breast feed * NICU admission which is predicted to be at least 72 hours from time of admission
Exclusion criteria
* Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies) * Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc) * Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana) * Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications * Any infant whose care is considered futile by the primary medical team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Feasibility_3 | 6-8 weeks chronological age | Feasibility will be evaluated by: rate of adherence to the study diet. |
| Study Feasibility_2 | 6-8 weeks chronological age | Feasibility will be evaluated by: study completion rate |
| Study Feasibility_1 | 6-8 weeks chronological age | Feasibility will be evaluated by: consent rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding duration | 6-8 weeks chronological age | time infant received breastmilk since birth |
| Intent to Breastfeed | 6-8 weeks chronological age | Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no. |
| Growth: Height | 6-8 weeks chronological age | height in centimeters reported as a z-score |
| Growth: Head Circumference | 6-8 weeks chronological age | head circumference in centimeters reported as a z-score |
| Growth: Weight | 6-8 weeks chronological age | Weight in kilograms reported as a z-score |
| Percentage of Human Milk Consumption at Discharge | at the time of NICU discharge or 7 days of age, whichever is later | Maternal milk/total milk (percent) consumed by the neonate over 48 hours |
| Percentage of Human Milk Consumption After Discharge | 6-8 weeks chronological age | Maternal milk/total milk (percent) consumed by the infant over 48 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intestinal Microbiome: microbial profiling (genus level) | 7 days of age | Microbial profiling (genus level) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene |
| Intestinal Microbiome: alpha diversity (Chao1) | 7 days of age | Alpha diversity (Chao1) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene |
Countries
United States
Outcome results
None listed