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

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05251441
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
12.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Breast Milk Fortifier supplements
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: F50

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

Dietary Supplement: 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.
Other Names:
  • F50

    		•
    Active Comparator: F100

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

    Dietary Supplement: 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.
    Other Names:
  • F50

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Weight gain rate (grams/day) [1 year]

    2. Duration of parenteral nutrition (days) [1 year]

    3. Time to discharge (days) [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Months
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara City Hospital Bilkent Ankara Turkey 06000

    Sponsors and Collaborators

    • Ankara City Hospital Bilkent

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ankara City Hospital Bilkent
    ClinicalTrials.gov Identifier:
    NCT05251441
    Other Study ID Numbers:
    • 26379996
    First Posted:
    Feb 22, 2022
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ankara City Hospital Bilkent
    Breast Milk Fortifier
    Nutrition
    Additional relevant MeSH terms:
    Premature Birth
    Birth Weight

    Study Results

    No Results Posted as of Feb 22, 2022