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

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05251441
• Other study ID #: 26379996
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2021
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Premature
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital Bilkent	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Weight gain rate (grams/day)		1 year
Secondary	Duration of parenteral nutrition (days)		1 year
Secondary	Time to discharge (days)		1 year