NCT05251441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

February 22, 2022

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 24, 2021

Last Update Submit

February 18, 2022

Conditions

Breast Milk Fortifier SupplementsPremature

Keywords

Breast Milk FortifierNutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Weight gain rate (grams/day)

    1 year

  • Duration of parenteral nutrition (days)

    1 year

  • Time to discharge (days)

    1 year

Study Arms (2)

F50

EXPERIMENTAL

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

Dietary Supplement: Breast Milk Fortifier supplements

F100

ACTIVE COMPARATOR

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

Dietary Supplement: Breast Milk Fortifier supplements

Interventions

Breast Milk Fortifier supplementsDIETARY_SUPPLEMENT

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.

Also known as: F50
F100F50

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm babies born weighing less than 1500 grams

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27112041BACKGROUND

  • 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.

    PMID: 32458060BACKGROUND

  • 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.

    PMID: 24180239BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2021

First Posted

February 22, 2022

Study Start

July 1, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

February 22, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)