Enteral Feeding of Premature Babies and Olive Oil Supplementation

Bursa City Hospital

Status: Enrolling

Conditions: Enteral Feeding; Premature; Olive Oil

Treatments: Dietary Supplement: Extra virgin organic olive oil (ULTRA PREMIUM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06072625

BCH-2023-12/8

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 14 to 40 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Olive oil group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Extra virgin organic olive oil (ULTRA PREMIUM)

Control group

No Intervention group