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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: June 1, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: F50
    • Patients in the group in which fortification was started when enteral nutrition reached 50 cc/kg
  • Active Comparator: F100
    • Patients in the group in which fortification was started when enteral nutrition reached 100 cc/kg

Clinical Trial Outcome Measures

Primary Measures

  • The effect of time to start breast milk fortifiers on full enteral feeding day.
    • Time Frame: 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 Measures

  • Weight gain rate (grams/day)
    • Time Frame: 1 year
  • Duration of parenteral nutrition (days)
    • Time Frame: 1 year
  • Time to discharge (days)
    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ankara City Hospital Bilkent
  • Provider of Information About this Clinical Study
    • Sponsor

References

Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23.

Basu S, Upadhyay J, Singh P, Kumar M. Early versus late fortification of breast milk in preterm infants: a systematic review and meta-analysis. Eur J Pediatr. 2020 Jul;179(7):1057-1068. doi: 10.1007/s00431-020-03677-6. Epub 2020 May 27.

Maas C, Wiechers C, Bernhard W, Poets CF, Franz AR. Early feeding of fortified breast milk and in-hospital-growth in very premature infants: a retrospective cohort analysis. BMC Pediatr. 2013 Nov 4;13:178. doi: 10.1186/1471-2431-13-178.

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