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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Olive Oil Adverse Reaction, Nursing Caries, Enteral and Supplement Feeds Adverse Reaction, Preterm

Intervention / Treatment
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* Dietary Supplement: Olive oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants; Between the 28th-36th weeks of gestation Weighing over 1000 g during the study Stable vital signs Being able to consume 75% of the total protein and energy through an orogastric tube Fed with breast milk and breast milk fortifiers Exclusion Criteria: Presence of; Necrotizing enterocolitis Pneumothorax Skull fracture Major congenital anomalies Suspected or diagnosis of metabolic disease History of pathological jaundice (jaundice developing in the first 24 hours), History of surgery that might affect the residual Using muscle relaxants, analgesics, sedative or inotropic drugs

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Olive oil<br>In our unit, according to the recommendations to start and increase enteral feeding in preterm infants in the Turkish Neonatal Society feeding group, Total Parenteral Nutrition (TPN) and Minimal Enteral Nutrition (MEN) are started from the first day. If the infant's weight is between 1000-1500 grams, it is increased to feed the infant as 15-20 ml/kg/day (for 1-2 days) and then 30 ml/kg/day every 2-3 hours. If the infant's weight is between 1500-1800 grams, he/she is fed as 20 ml/kg for 1 day and then 30 ml/kg/day, every 3 hours. BM fortification is initiated when feeding reaches 50-100 ml/kg (recommended 80 ml/kg) [21].At this stage (approximately from the seventh day after starting to take 25-30 ml/kg/day orally), 0.5 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. | Dietary Supplement: Olive oil<br>* 0.5 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<br>|
| No Intervention: Recommendations to start enteral feeding<br>In our unit, according to the recommendations to start and increase enteral feeding in preterm infants in the Turkish Neonatal Society feeding group, Total Parenteral Nutrition (TPN) and Minimal Enteral Nutrition (MEN) are started from the first day. If the infant's weight is between 1000-1500 grams, it is increased to feed the infant as 15-20 ml/kg/day (for 1-2 days) and then 30 ml/kg/day every 2-3 hours. If the infant's weight is between 1500-1800 grams, he/she is fed as 20 ml/kg for 1 day and then 30 ml/kg/day, every 3 hours. BM fortification is initiated when feeding reaches 50-100 ml/kg (recommended 80 ml/kg) [21]. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain of preterm infants | The infants' weight gain were monitored daily until discharge | up to 6 months | 
| length of hospital stay of preterm infants | The hospital stays of the control and experimental groups were recorded. | up to 6 months | 
| developing prematurity-related complications (Bronkopulmoner displazi (BPD), Retinopathy of prematurity (ROP), Gastric intolerance (GI)) | Gastric intolerance (GI) was considered as the inability to digest more than 50% of the enteral nutrition presented as the Gastric Residual Volume (GRV), or abdominal distention and vomiting, or both, and accordingly, the patient's nutritional plan being disrupted [6]. In the findings of ROP, the ROP Diagnosis and Treatment Guidelines were considered, and it was evaluated as severe ROP in case of ROP being stage 3 or higher in both eyes or in case of the infant being treated with laser or antivascular endothelial growth factor therapy [19]. BPD was graded according to the BPD Prevention and Follow-up Guidelines, and all mild/moderate/severe cases were enrolled in the research. Jaundice levels of preterm infants were studied by examining direct bilirubin in the blood. Infants with a history of pathological jaundice were not included in the research [20]. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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olive oil, neonatal intensive unit, Preterm infant