NCT05251441|UnknownDMC
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Sponsor study identifier
interventional
160
1 country
1
Study Start
July 1, 2021
Actual (reported)Primary Completion
June 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2021
Actual (reported)September 24, 2021
Actual (reported)February 22, 2022
Actual (reported)June 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The effect of time to start breast milk fortifiers on full enteral feeding day.
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.
1 year
Weight gain rate (grams/day)
1 year
Duration of parenteral nutrition (days)
1 year
Time to discharge (days)
1 year
Patients in the group in which fortification was started when enteral nutrition reached 50 cc/kg
Patients in the group in which fortification was started when enteral nutrition reached 100 cc/kg
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ankara City Hospital Bilkent
Ankara, 06000, Turkey (Türkiye)
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.
First Submitted
September 24, 2021
First Posted
February 22, 2022
Study Start
July 1, 2021
Actual (reported)Primary Completion
June 1, 2022
Estimated (date passed)Intervention Facilitates Oral Feeding in Premature Infants
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 22, 2022
Record last verified: 2021-09
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