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

Not Applicable

• Conditions: Breast Milk Fortifier Supplements; Premature
• Interventions: Dietary Supplement: Breast Milk Fortifier supplements

• Registration Number: NCT05251441
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22
• Primary Completion: 2022-06-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
F50	Breast Milk Fortifier supplements	Patients in the group in which fortification was started when enteral nutrition reached 50 cc/kg
F100	Breast Milk Fortifier supplements	Patients in the group in which fortification was started when enteral nutrition reached 100 cc/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to discharge (days)	1 year
Weight gain rate (grams/day)	1 year
Duration of parenteral nutrition (days)	1 year

Trial Locations

Locations (1)

Ankara City Hospital Bilkent; 🇹🇷 Ankara, Turkey