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NCT Number: NCT06072625

Enteral Feeding of Premature Babies and Olive Oil Supplementation

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.

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Key information

Conditions

Premature Enteral Feeding Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Olive Oil Pregnancy Complications Premature Birth Urogenital Diseases

Age range

14 day–40 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra virgin organic olive oil (ULTRA PREMIUM)

Dietary Supplement

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

Primary outcomes

  1. Number of patients who completed the study

    Time frame: 15 months

    To enrolment of 40 babies in the study in both groups

  2. Postnatal growth retardation rates

    Time frame: 18 months

    Daily weight intake amounts of babies in both groups

Secondary outcomes

  1. Frequency and severity of retinopathy of prematurity

    Time frame: 18 months

    Frequency and severity of retinopathy of prematurity

Study contacts

Contact information is provided by the study sponsor or research team.

Ayten Erdoğan Ordu, MD

CONTACT

[email protected]

+905389429336

Murat Tutanc, Prof

CONTACT

[email protected]

+905553803484

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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