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

Ankara City Hospital

Status

Unknown

Conditions

Premature

Breast Milk Fortifier Supplements

Treatments

Dietary Supplement: Breast Milk Fortifier supplements

Study type

Interventional

Funder types

Other

Identifiers

NCT05251441

26379996

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

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