The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.

Conditions
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Breast Milk Fortifier Supplements, Premature

Intervention / Treatment
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* Dietary Supplement: Breast Milk Fortifier supplements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F50<br>Patients in the group in which fortification was started when enteral nutrition reached 50 cc/kg | Dietary Supplement: Breast Milk Fortifier supplements<br>* 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.<br>* Other names: F50;|
| Active Comparator: F100<br>Patients in the group in which fortification was started when enteral nutrition reached 100 cc/kg | Dietary Supplement: Breast Milk Fortifier supplements<br>* 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.<br>* Other names: F50;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of time to start breast milk fortifiers on full enteral feeding day. | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain rate (grams/day) |  | 1 year | 
| Duration of parenteral nutrition (days) |  | 1 year | 
| Time to discharge (days) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Milk Fortifier, Nutrition