Olive Oil Adverse ReactionNCT05815849
Effect of Enteral Olive Oil Supplement On Weight Gain and Development of Some Complications in Preterm
A study testing Olive oil in people with Olive Oil Adverse Reaction and Nursing Caries, run by Kocaeli University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 28 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Olive Oil Adverse Reaction, Nursing Caries, Enteral and Supplement Feeds Adverse Reaction
- What is being tested?
- Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Presence of;
- Necrotizing enterocolitis
- Pneumothorax
- Skull fracture
- Major congenital anomalies
- Suspected or diagnosis of metabolic disease
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Olive Oil Adverse Reaction, Nursing Caries, Enteral and Supplement Feeds Adverse Reaction, Preterm
- Being tested
- Olive oil
- Keywords
- olive oil, neonatal intensive unit, Preterm infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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]. |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain of preterm infants
The infants' weight gain were monitored daily until discharge
Measured: up to 6 months
length of hospital stay of preterm infants
The hospital stays of the control and experimental groups were recorded.
Measured: 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].
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jun 2020
- Primary completion1 Mar 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Olive Oil Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Yalnızoglu Caka, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815849
- Sponsor's protocol ID
- YYB22032023
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11724460Sharda 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.
PubMed 16968976Lembo C, Buonocore G, Perrone S. Oxidative Stress in Preterm Newborns. Antioxidants (Basel). 2021 Oct 23;10(11):1672. doi: 10.3390/antiox10111672.
PubMed 34829543Robinson 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.
PubMed 27599697Grimm 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.
PubMed 16041475Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.
PubMed 21730906Su 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.
PubMed 24050843Patel P, Bhatia J. Human milk: the preferred first food for premature infants. Journal of Human Nutrition & Food Science. 2016;4(5):1098.
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.
PubMed 27347886Amissah 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.
PubMed 32842164Underwood 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.
PubMed 23178065Lucas 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.
PubMed 21443487Thureen 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.
PubMed 17245100Drenckpohl 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.
PubMed 18829797Salama 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.
PubMed 25698888
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05815849
- Acronym / sponsor ID
- YYB22032023
- Conditions
- Olive Oil Adverse Reaction, Nursing Caries, Enteral and Supplement Feeds Adverse Reaction, Preterm
- Keywords
- olive oil, neonatal intensive unit, Preterm infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olive oil | Active comparator | Dietary Supplement: Olive oilIn 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. |
| 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]. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Presence of;
- Necrotizing enterocolitis
- Pneumothorax
- Skull fracture
- Major congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive 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 | Dietary supplement | Olive oil |
Primary outcome
weight gain of preterm infants
Time frame: up to 6 months
The infants' weight gain were monitored daily until discharge
length of hospital stay of preterm infants
Time frame: up to 6 months
The hospital stays of the control and experimental groups were recorded.
developing prematurity-related complications (Bronkopulmoner displazi (BPD), Retinopathy of prematurity (ROP), Gastric intolerance (GI))
Time frame: up to 6 months
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].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 11724460Uauy 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.
- Background: PubMed 16968976Sharda 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.
- Background: PubMed 34829543Lembo C, Buonocore G, Perrone S. Oxidative Stress in Preterm Newborns. Antioxidants (Basel). 2021 Oct 23;10(11):1672. doi: 10.3390/antiox10111672.
- Background: PubMed 27599697Robinson 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.
- Background: PubMed 16041475Grimm 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.
- Background: PubMed 21730906Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.
- Background: PubMed 24050843Su 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.
- BackgroundPatel P, Bhatia J. Human milk: the preferred first food for premature infants. Journal of Human Nutrition & Food Science. 2016;4(5):1098.
- Background: PubMed 27347886Bhatia 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.
- Background: PubMed 32842164Amissah 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.
- Background: PubMed 23178065Underwood 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.
- Background: PubMed 21443487Lucas 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive oil in people with Olive Oil Adverse Reaction and Nursing Caries, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain of preterm infants (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05815849, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.