Enteral Feeding of Premature Babies and Olive Oil Supplementation

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06072625
• Other study ID #: BCH-2023-12/8
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: Bursa City Hospital
• Contact: Ayten Erdogan Ordu, MD
• Phone: +905389429336
• Email: aytenli21[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Days to 40 Days

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding
• Premature
• Premature Birth

Intervention

Dietary Supplement:
• Extra virgin organic olive oil (ULTRA PREMIUM)
Babies who have fully enteral feeding will take oral, 1 ml/kg/day of extra virgin olive-oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa City Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who completed the study	To enrolment of 40 babies in the study in both groups	15 months
Primary	Postnatal growth retardation rates	Daily weight intake amounts of babies in both groups	18 months
Secondary	Frequency and severity of retinopathy of prematurity	Frequency and severity of retinopathy of prematurity	18 months