The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
Primary Purpose
Breast Milk Fortifier Supplements, Premature
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breast Milk Fortifier supplements
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Milk Fortifier Supplements focused on measuring Breast Milk Fortifier, Nutrition
Eligibility Criteria
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
Sites / Locations
- Ankara City Hospital Bilkent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
F50
F100
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Weight gain rate (grams/day)
Duration of parenteral nutrition (days)
Time to discharge (days)
Full Information
NCT ID
NCT05251441
First Posted
September 24, 2021
Last Updated
February 18, 2022
Sponsor
Ankara City Hospital Bilkent
1. Study Identification
Unique Protocol Identification Number
NCT05251441
Brief Title
The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
Official Title
The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Milk Fortifier Supplements, Premature
Keywords
Breast Milk Fortifier, Nutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
F50
Arm Type
Experimental
Arm Description
Patients in the group in which fortification was started when enteral nutrition reached 50 cc/kg
Arm Title
F100
Arm Type
Active Comparator
Arm Description
Patients in the group in which fortification was started when enteral nutrition reached 100 cc/kg
Intervention Type
Dietary Supplement
Intervention Name(s)
Breast Milk Fortifier supplements
Other Intervention Name(s)
F50
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of time to start breast milk fortifiers on full enteral feeding day.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Weight gain rate (grams/day)
Time Frame
1 year
Title
Duration of parenteral nutrition (days)
Time Frame
1 year
Title
Time to discharge (days)
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ankara City Hospital Bilkent
City
Ankara
ZIP/Postal Code
06000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27112041
Citation
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.
Results Reference
background
PubMed Identifier
32458060
Citation
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.
Results Reference
background
PubMed Identifier
24180239
Citation
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.
Results Reference
background
Learn more about this trial
The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
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