The Effect of Enteral Organic Extra Virgin Oil Supplementation in Premature Babies on Postnatal Growth, Premature Morbidities, and Oxidative Status.
Bayram Ali Dorum, Ayten Erdoğan, Salih Çağrı Çakır...
https://pubmed.ncbi.nlm.nih.gov/41897040Actively Recruiting
Phase Not Applicable
Age: 14Days - 40Days
All Genders
Healthy Volunteers
ID06072625
The Effect of Enteral Organic Extra Virgin Olive Oil Supplementation in Premature Babies on Postnatal Growth and Premature Morbidities
Led by Bursa City Hospital · Updated on 2024-07-15
80
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying premature babies born at 32 weeks or earlier to evaluate the effects of extra virgin organic olive oil supplementation on postnatal growth and common complications in prematurity such as retinopathy of prematurity, bronchopulmonary dysplasia, and necrotizing enterocolitis. This is a randomized, single-blind, interventional study involving 40 babies divided into two groups: an intervention group and a control group. Babies in the intervention group who tolerate full enteral feeding by the end of their second week will receive 1 ml/kg/day of extra virgin organic olive oil orally until discharge or the 36th week. The control group will not receive this supplementation. Throughout the study, daily lipid intake will be tracked using breast milk analysis, and lipid profiles will be monitored weekly. Participants will have blood samples taken before the intervention, on day 14 for the control group, and at the end of the study to measure serum total antioxidant capacity and malondialdehyde levels. Growth parameters will be assessed daily. The research team will compare outcomes between groups, focusing on growth retardation rates and the frequency and severity of prematurity-related complications. The study is planned to last 15 to 18 months for outcome measurement and monitoring.
CONDITIONS
Brief Title
Enteral Feeding of Premature Babies and Olive Oil Supplementation
Who Can Participate
Age: 14Days - 40Days
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Premature babies born at 32 weeks or less
- Babies who tolerate full enteral feeding before the end of the second week
- Babies whose parents have given consent
You will not qualify if you...
- Having a congenital or genetic anomaly
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 15 months
Participants who tolerate full enteral feeding will receive 1 ml/kg/day of extra virgin olive oil orally.
Visits as scheduled during the treatment period
Follow-up
Duration - Up to 3 months after treatment
Participants are monitored for postnatal growth and morbidities after treatment completion.
Visits as scheduled during follow-up
Trial Site Locations
Total: 1 location
1
Bursa City Hospital
Bursa, Turkey (Türkiye), 16110
Actively Recruiting
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Research Team
A
Ayten Erdoğan Ordu, MD
M
Murat Tutanc, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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