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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-08-01

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.

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Detailed Description

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Conditions

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Breast Milk Fortifier Supplements Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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F50

Patients in the group in which fortification was started when enteral nutrition reached 50 cc/kg

Group Type EXPERIMENTAL

Breast Milk Fortifier supplements

Intervention Type DIETARY_SUPPLEMENT

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.

F100

Patients in the group in which fortification was started when enteral nutrition reached 100 cc/kg

Group Type ACTIVE_COMPARATOR

Breast Milk Fortifier supplements

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Breast 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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F50

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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No