Enteral Feeding of Premature Babies and Olive Oil Supplementation

The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06072625

Enrollment

Registered

2023-10-10

Start date

2023-10-01

Completion date

2025-03-31

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding, Olive Oil, Premature

Brief 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.

Interventions

DIETARY_SUPPLEMENTExtra virgin organic olive oil (ULTRA PREMIUM)

Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

14 Days to 40 Days

Healthy volunteers

Yes

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 criteria

* Having a congenital or genetic anomaly

Design outcomes

Primary

Measure	Time frame	Description
Number of patients who completed the study	15 months	To enrolment of 40 babies in the study in both groups
Postnatal growth retardation rates	18 months	Daily weight intake amounts of babies in both groups

Secondary

Measure	Time frame	Description
Frequency and severity of retinopathy of prematurity	18 months	Frequency and severity of retinopathy of prematurity

Countries

Turkey (Türkiye)

Contacts

Primary ContactAyten Erdoğan Ordu, MD

aytenli21@hotmail.com+905389429336

Backup ContactMurat Tutanc, Prof

drtutanc@hotmail.com+905553803484

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026