NCT05815849

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

March 22, 2023

Last Update Submit

April 4, 2023

Conditions

Olive Oil Adverse ReactionNursing CariesEnteral and Supplement Feeds Adverse ReactionPreterm

Keywords

olive oilneonatal intensive unitPreterm infant

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Olive oil

ACTIVE COMPARATOR

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

Recommendations to start enteral feeding

NO INTERVENTION

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) \[21\].

Interventions

Olive oilDIETARY_SUPPLEMENT

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

Olive oil

Eligibility Criteria

Age28 Weeks - 36 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, İzmit, Turkey (Türkiye)

Location

Related Publications (21)

  • 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.

    PMID: 11724460BACKGROUND

  • 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.

    PMID: 16968976BACKGROUND

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

    PMID: 34829543BACKGROUND

  • 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.

    PMID: 27599697BACKGROUND

  • 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.

    PMID: 16041475BACKGROUND

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

    PMID: 21730906BACKGROUND

  • 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.

    PMID: 24050843BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 27347886BACKGROUND

  • 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.

    PMID: 32842164BACKGROUND

  • 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.

    PMID: 23178065BACKGROUND

  • 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.

    PMID: 21443487BACKGROUND

  • 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.

    PMID: 17245100BACKGROUND

  • 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.

    PMID: 18829797BACKGROUND

  • 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.

    PMID: 25698888BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 31236022BACKGROUND

  • Derneği TN, Derneği 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

    BACKGROUND

  • Derneği TN. Yenidoğan Sarılıklarında Yaklaşım, İzlem 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

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blinding was used in the study. For this purpose, the participants were not specified in which group they belonged to the research. Therefore, a separate informed consent form was prepared for each group. In order to avoid bias in the analysis of the research data, statistician blinding was also applied. While coding the research data, the research groups were coded as A and B, and the statistician was prevented from knowing which letter represented which group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 18, 2023

Study Start

June 1, 2020

Primary Completion

March 1, 2021

Study Completion

August 1, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)