Clinical Trials Directory

Trials / Completed

CompletedNCT05815849

Effect of Enteral Olive Oil Supplement On Weight Gain and Development of Some Complications in Preterm

Effect of Enteral Olive Oil Supplement On Weight Gain, Length of Hospital Stay, And Development of Some Complications in Very Low Birth-Weight Infants: A Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
96 (actual)
Sponsor
Kocaeli University · Academic / Other
Sex
All
Age
28 Weeks – 36 Weeks
Healthy volunteers
Accepted

Summary

Objective: The objective of the present research is to compare the nutritional status, weight gain, length of hospital stay, and development of some complications in very low birth-weight (VLBW) infants who received and did not receive olive oil supplementation enterally.

Detailed description

It is known that nutrition of very low birth-weight (VLBW, \<1500 g) neonates is as crucial as the treatments they receive in the neonatal intensive care unit to prevent problems that may develop in long-term follow-ups and increase their quality of life. VLBW neonates need parenteral nutrition as an energy source to ensure optimal growth, and lipid emulsion represents an indispensable part of total parenteral nutrition \[1\]. VLBW neonates with an underdeveloped immune system and antioxidant defense due to preterm birth are vulnerable to oxidative stress, which takes an important part in the development of diseases, e.g., chronic lung disease (CLD), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and intraventricular hemorrhage, which may increase the risk of morbidity \[2,3\]. Prematurity also causes the insufficient supply of long-chain polyunsaturated fatty acids (LC-PUFAs), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), most of which are transferred to the fetus during the third trimester of pregnancy \[4\]. These LC-PUFAs are essential and important for visual and cognitive development and reducing thrombotic and inflammatory responses \[5\]. The continuation of intrauterine growth and development in the extrauterine period without interruption may be possible by providing parenteral and enteral nutrition support in the early period and maintaining this support uninterruptedly \[6\]. Studies have proved that breast milk is the gold standard for feeding neonates under all conditions. However, despite its enormous benefits, unsupplemented breast milk can be nutritionally inadequate for preterm infants for various reasons. First, breast milk does not have a sufficient amount of some nutrients required to ensure the rapid growth of preterm infants \[7\], and nutrient concentrations can fluctuate over time. Of these, fat is one of the most variable nutrients \[8\]. Studies have demonstrated that there are temporal and interindividual differences according to the mother's diet, time of day, and breastfeeding duration (e.g., a richer fat content of hindmilk) \[9,10\]. When breast milk alone cannot meet these needs, it is recommended that special nutritional supplements in the form of powder or liquid be added to breast milk and given to the infant \[11\]. Due to its content, olive oil has antioxidant, cell regenerative, and anti-carcinogenic properties that help digestion \[12\]. There are clear pieces of evidence indicating that parenterally administered oil emulsions can be well tolerated by VLBW and even extremely low birth-weight infants from the first day and even from the first 1-2 hours of life \[13-15\]. The objective of the current research was to compare the nutritional status, weight gain, length of hospital stay, and the development of some complications (BPD, ROP, GIS intolerance, etc.) in preterm neonates who received and did not receive olive oil enterally for calorie support.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTOlive oil0.5 cc/30 ml of olive oil (a brand easily available in the markets) was added to the milk at each feeding of the infants in the intervention group

Timeline

Start date
2020-06-01
Primary completion
2021-03-01
Completion
2021-08-01
First posted
2023-04-18
Last updated
2023-04-18

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05815849. Inclusion in this directory is not an endorsement.