Breast Milk Fortifier Supplements, Premature
Conditions
Keywords
Breast Milk Fortifier, Nutrition
Brief summary
In the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and breast milk enrichment will be started when 100 ml/kg/day enteral feeding is reached in the other group. In the study, the babies in these two groups will be compared by making early (nutrition characteristics and premature morbidity) and long-term follow-ups. In this study, a 30% reduction in the transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. In our study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups.
Interventions
DIETARY_SUPPLEMENTBreast Milk Fortifier supplements
Current information is recommended for breast milk supplementation in premature babies. However, there is no consensus on when it will start. For breast milk supplementation, we planned to supplement one group of our patients with enteral nutrition of 50 ml/kg/day and the other group when they reached 100 ml/kg/day.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
* Preterm babies born weighing less than 1500 grams
Exclusion criteria
* Babies with congenital anomalies * Infants who develop necrotizing enterocolitis or spontaneous intestinal perforation before starting a breast milk fortifier * Babies lost before reaching 50 cc/kg enteral nutrition * Babies who are not breastfed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of time to start breast milk fortifiers on full enteral feeding day. | 1 year | In this study, a 30% reduction in transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. In the study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups. |
Secondary
| Measure | Time frame |
|---|---|
| Weight gain rate (grams/day) | 1 year |
| Duration of parenteral nutrition (days) | 1 year |
| Time to discharge (days) | 1 year |
Countries
Turkey (Türkiye)
Outcome results
None listed