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

Nursing Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815849
• Other study ID #: YYB22032023
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: April 2023
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Nursing Caries
• Premature Birth
• Preterm
• Weight Gain

Intervention

Dietary Supplement:
• Olive oil
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

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli	Izmit

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (21)

Amini E, Shariat M, Nayeri F, et al. A randomized controlled clinical trial of olive oil added to human breast milk for weight gaining in very low birth weight infants. J Family Reprod Health. 2011; 5(3):73-78.

Amissah EA, Brown J, Harding JE. Fat supplementation of human milk for promoting growth in preterm infants. Cochrane Database Syst Rev. 2020 Aug 25;8(8):CD000341. doi: 10.1002/14651858.CD000341.pub3. — View Citation

Bhatia J. Human Milk for Preterm Infants and Fortification. Nestle Nutr Inst Workshop Ser. 2016;86:109-19. doi: 10.1159/000442730. Epub 2016 Jun 27. — View Citation

Dernegi TN, Dernegi TO. Türkiye Prematüre Retinopatisi Rehberi 2021 Güncellemesi. [cited 2022 Aug 27]. Available from: http://www.neonatology.org.tr/wp-content/uploads/2021/08/Turkiye-Premature-Retinopa-tisi-2021-Guncellemesi-1.pdf

Dernegi TN. Yenidogan Sariliklarinda Yaklasim, Izlem ve Tedavi Rehberi 2022 Güncellemesi. [cited 2022 Aug 27]. Available from: http://www.neonatology.org.tr/wp-content/uploads/2022/09/Turk-Neonatoloji-Dernegi-Sarilik-Rehberi-2022-Guncellemesi.pdf

Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282. — View Citation

Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22. — View Citation

Kanik EA, Tasdelen B, Erdogan S. Klinik Denemelerde Randomizasyon. Marmara Medical Journal. 2011;24(3), 149-155.

Kültürsay N, Bilgen H, Türkyilmaz C. Türk Neonatoloji Dernegi Prematüre ve Hasta Term Bebegin Beslenmesi Rehberi 2018 Güncellemesi. Ankara, Türk Neonatoloji Dernegi. [cited 2022 Aug 27]. Available from: https://www.neonatology.org.tr/wp-content/uploads/2020/04/premature_rehber_2018.pdf

Lembo C, Buonocore G, Perrone S. Oxidative Stress in Preterm Newborns. Antioxidants (Basel). 2021 Oct 23;10(11):1672. doi: 10.3390/antiox10111672. — View Citation

Lucas L, Russell A, Keast R. Molecular mechanisms of inflammation. Anti-inflammatory benefits of virgin olive oil and the phenolic compound oleocanthal. Curr Pharm Des. 2011;17(8):754-68. doi: 10.2174/138161211795428911. — View Citation

Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e. — View Citation

Patel P, Bhatia J. Human milk: the preferred first food for premature infants. Journal of Human Nutrition & Food Science. 2016;4(5):1098.

Robinson DT, Martin CR. Fatty acid requirements for the preterm infant. Semin Fetal Neonatal Med. 2017 Feb;22(1):8-14. doi: 10.1016/j.siny.2016.08.009. Epub 2016 Sep 3. — View Citation

Salama GS, Kaabneh MA, Almasaeed MN, Alquran MIa. Intravenous lipids for preterm infants: a review. Clin Med Insights Pediatr. 2015 Feb 9;9:25-36. doi: 10.4137/CMPed.S21161. eCollection 2015. — View Citation

Satar M, Arisoy AE, Celik IH. Turkish Neonatal Society guideline on neonatal infections-diagnosis and treatment. Turk Pediatri Ars. 2018 Dec 25;53(Suppl 1):S88-S100. doi: 10.5152/TurkPediatriArs.2018.01809. eCollection 2018. — View Citation

Sharda B. Free radicals: emerging challenge in environmental health research in childhood and neonatal disorders. Int J Environ Res Public Health. 2006 Sep;3(3):286-91. doi: 10.3390/ijerph2006030035. — View Citation

Su BH. Optimizing nutrition in preterm infants. Pediatr Neonatol. 2014 Feb;55(1):5-13. doi: 10.1016/j.pedneo.2013.07.003. Epub 2013 Sep 16. — View Citation

Thureen PJ. Early aggressive nutrition in very preterm infants. Nestle Nutr Workshop Ser Pediatr Program. 2007;59:193-204; discussion 204-8. doi: 10.1159/000098536. — View Citation

Uauy R, Hoffman DR, Peirano P, Birch DG, Birch EE. Essential fatty acids in visual and brain development. Lipids. 2001 Sep;36(9):885-95. doi: 10.1007/s11745-001-0798-1. — View Citation

Underwood MA. Human milk for the premature infant. Pediatr Clin North Am. 2013 Feb;60(1):189-207. doi: 10.1016/j.pcl.2012.09.008. Epub 2012 Oct 18. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain of preterm infants	The infants' weight gain were monitored daily until discharge	up to 6 months
Primary	length of hospital stay of preterm infants	The hospital stays of the control and experimental groups were recorded.	up to 6 months
Primary	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