Enteral Feeding of Premature Babies and Olive Oil Supplementation

Last updated: July 12, 2024
Sponsor: Bursa City Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Extra virgin organic olive oil (ULTRA PREMIUM)

Clinical Study ID

NCT06072625
BCH-2023-12/8
  • Ages 14-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

It is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. In the intervention group, babies will take 1 ml/kg/day of the study product (ULTRA PREMIUM) after full enteral feeding.

Supplementation will continue until discharge or the 36th week. Blood samples will be taken for serum Total antioxidant capacity and Malondialdehyde levels before the intervention and on the 14th day of the control group. At the end of the study, serum will be taken again for control values.

Daily lipid intake amounts will be recorded through breast milk analysis. Lipid profile will be monitored weekly The growth parameters of babies will be monitored daily It will be evaluated at the end of the study in terms of ROP, BPD, and NEC. At the end of the study, the data of babies in both groups will be compared.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Premature babies born at 32 weeks or less

  • Babies who tolerate full enteral feeding at the before end of the second week

  • Babies given consent by their parents -

Exclusion

Exclusion Criteria:

  • Having a congenital or genetic anomaly

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Extra virgin organic olive oil (ULTRA PREMIUM)
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Bursa City Hospital

    Bursa, 16110
    Turkey

    Active - Recruiting

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