Health TrialsbyHealthPanel

Enteral Feeding of Premature Babies and Olive Oil Supplementation

ConditionsPrematureOlive OilEnteral Feeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-40
SponsorBursa City Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 -

Disqualifiers

Having a congenital or genetic anomaly

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Olive oil groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of patients who completed the study

To enrolment of 40 babies in the study in both groups

Time frame
15 months
2

Postnatal growth retardation rates

Daily weight intake amounts of babies in both groups

Time frame
18 months

Secondary outcomes

1

Frequency and severity of retinopathy of prematurity

Frequency and severity of retinopathy of prematurity

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bursa City Hospital

Lead sponsor

Source ClinicalTrials.gov
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