Breast Milk ExpressionRDSNCT02832011
How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth
A study testing olive oil and Eoprotin in people with Breast Milk Expression and Premature Birth of Newborn, run by nihat demir.
Trial summary
This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged, below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin or olive-oil fortified breast milk. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Expression, Premature Birth of Newborn
- What is being tested?
- olive oil and Eoprotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2017
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with <1500 g birth weight
- Infants with< 32 weeks of gestational age
- Infants who will be fed with maternal milk that is fortified with eoprotin and olive oil
Who cannot join
- Critical ill patients
- Evident severe congenital malformation
- Intolerance of feeding
- Evident gastrointestinal malformation
About this study
Official title: The Effect on Immunological Parameters and Growth of Olive Oil and Eoprotin Used as a Fortification Breast Milk at the VLBW Babies
This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged, below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin or olive-oil fortified breast milk. Cases will receive same amount of calorie intake either with eoprotin or olive oil fortified-breast milk. If investigators identify that olive oil doesn't increase proinflammatory cytokines and grant enough weight gain in premature infants at the end of the study, investigators will suggest olive oil to replace eoprotin which is a very costly breast milk-fortifier.
Read the detailed description
Low birth weight infants are premature infants that born with birth weight less than 1500 g. Because these infants have low birth weight, weight gain can be increased by fortifying breast milk after post-natal 7. day. Breast milk fortifiers might be preferred for very low birth weight or extremely low birth weight infants (infants with <1000 g birth weight infants) for faster weight gain. It does not increase risk of necrotizing enterocolitis or infection; and it has lower incidences of necrotizing enterocolitis and sepsis comparing to formula. Breast milk is usually fortified with 100 cc/kg/day enteral feeding (1,2,3,4). Even though many centers use olive oil to fortify breast milk for many years; there is no study to evaluate its scientific value. Hence it has been known that olive oil based parenteral nutrition solutions are well-tolerated by premature infants, are immunologically more neutral, does not increase proinflammatory cytokines; olive oil is the only fat consumed in its natural form and has antimicrobial and cytotoxic effects, lowers serum cholesterol concentration by decreasing cholesterol absorption, has protective measures against cardiovascular diseases due to antioxidant effects of ingredients such as mono- and poly-unsaturated fatty acids, phenolic substances, tocopherols and carotenoids; olive oil has antioxidant, cell renewal and anti- carcinogenic features because of containing squalene which is precursor of steroid synthesis and help digestion by increasing digestive juice by major pigments such as chlorophyll, pheophytin and chlorophyll (5).
In previous studies; it has been shown that nutritional support with parenteral olive oil emulsion has better plasma lipid content similarities to breast milk, lower proinflammatory cytokine synthesis, lower lipid peroxidation product levels, stronger T-cell response, higher E vitamin levels; and thus lower risk of nosocomial infections, SIRS (systemic inflammatory response syndrome), BPD (bronchopulmonary dysplasia), NEC (necrotizing enterocolitis), PVL (periventricular leukomalacia), ROP (retinopathy of prematurity) and cardiovascular diseases and positive impact on glucose metabolism. Participants hypothesize that oral olive oil intake will have similar effects (6).
Investigators aims to compare post-nutritional immunologic parameters of 1-28 day-aged 60 infants with <1500 g birth weight and < 32 weeks of gestational age who were fed with maternal milk that is fortified with eoprotin and olive oil and diagnosed and followed-up in Neonatal Intensive Care Unit of Pediatrics Department of Medicine Faculty of Yüzüncü Yıl University.
This study will be conducted on 60 patients who are 1-28 days-aged, below 1500-gram body weight, born before 32 weeks of gestational age and diagnosed and followed in Neonatal Unit of Pediatrics Department of Medicine Faculty of Yüzüncü Yıl University. For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, vials will be thawed in room temperature and serum TNF-alpha, IL-1 Beta, IL-6, IL-8, IL-10 levels will be analyzed with ELISA method by BIO-Tec ELx800 Absorbance Reader device and lipid profiles (LDL, HDL, Total cholesterol and triglyceride) and levels will be analyzed with spectrophotometric method by Architect ci16200; then these parameters will be compared with each other.
After feeding with olive oil infants will have received same amount of calorie with infants who will receive eoprotin-fortified breast milk. At the end of study, if participants identify that olive oil doesn't increase proinflammatory cytokines and provide enough weight gain in premature infants, investigators will suggest olive oil to replace eoprotin which is a very costly breast milk-fortifier. Investigators believe this situation will contribute to both country and family budgets.
- Conditions
- Breast Milk Expression, Premature Birth of Newborn
- Being tested
- olive oil, Eoprotin
- Medical subject headings
- Breast Milk Expression, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olive oilDietary supplement
Also called Komili (extra virgin olive oil)
The infants fed with olive oil will have received same amount of calorie with infants who will receive eoprotin-fortified breast milk.
EoprotinDietary supplement
Also called aptamil
Low birth weight infants are premature infants that born with birth weight less than 1500 g. Because these infants have low birth weight, weight gain can be increased by fortifying breast milk after post-natal 7 with eoprotin.
| Study group | Role | What they receive |
|---|---|---|
| olive oil | Active comparator | After randomization, Investigators will give human milk fortified with olive oil Receives: Dietary Supplement: olive oil; Dietary Supplement: Eoprotin |
| Eoprotin | Active comparator | After randomization, Human milk fortified with Eoprotin according to the recommendations of the manufacturer (1g per 30ml milk) Receives: Dietary Supplement: olive oil; Dietary Supplement: Eoprotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum alpha tumor necrosis factor will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed tumor necrosis factor alpha with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
Measured: Within18 months
IL-1 Beta will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed IL-1 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
Measured: Within18 months
IL-6 will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed IL-6 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
Measured: Within18 months
IL-8 will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed IL-8 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
Measured: Within18 months
IL-10 will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed IL-10 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
Measured: Within18 months
Triglyceride will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed triglyceride with spectrophotometric method by Architect ci16200;
Measured: Within18 months
Total cholesterol will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed total cholesterol with spectrophotometric method by Architect ci16200;
Measured: Within18 months
Low density lipoprotein (LDL) will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed Low density lipoprotein (LDL) with spectrophotometric method by Architect ci16200;
Measured: Within18 months
High density lipoprotein (HDL) will be analyzed
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge.
At the end of the study, participants will be analyzed High density lipoprotein (HDL) with spectrophotometric method by Architect ci16200;
Measured: Within18 months
Secondary outcomes (6)
SIRS (systemic inflammatory response syndrome)
will be defined according to National Institutes of Health criteria.
Measured: Within 3 months of life
Chronic Lung Disease (CLD)
Chronic Lung Disease (CLD) will be defined according to National Institutes of Health criteria.
Measured: up to 36 weeks of post gestational age
Patent ductus arteriosus
Echocardiography will be performed routinely for patent ductus arteriosus within 5 days of life
Measured: Within 5 days of life
Intraventricular haemorrhage
We will assess for intraventricular haemorrhage higher than grade II using the Papile classification system
Measured: Within 1 month of life
Necrotising enterocolitis
Necrotising enterocolitis with the modified Bell's classification system
Measured: Within 3 months of life
Retinopathy of prematurity (ROP)
Retinopathy of prematurity (ROP) defined based on the criteria of the American Academy of Pediatrics, American Academy of Ophthalmology and American Association for Pediatric Ophthalmology and Strabismus.
Measured: Up to 3 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast Milk ExpressionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nihat demir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, nihat demir, Yuzuncu Yil University
- Investigators
- nihat demir, Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832011
- Sponsor's protocol ID
- 2015-TF-U362
- Acronym
- RDS
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Çelik HT, Yiğit Ş. Yenidoğan ve Prematüre Bebeklerde Parenteral Beslenmede Yenilikler. Hacettepe Tıp Dergisi 2009;40:176-189.
2. Gülcan H. Preterm Yenidoğanlarda Parenteral Beslenmede Yenilikler. Gaziantep Tıp Dergisi 2010;16:66-74.
3. Gürsoy T, Yurdakök M. Prematüre Bebeklerin Beslenmesi. Çocuk Sağlığı ve Hastalıkları Dergisi 2008;51:240-251.
4. Ergin H, Kılıç İ, Gürses D, Sözeri A, Özdemir C. Zenginleştirilmiş Anne Sütü (Eoprotin) Alan Prematüre Bebeklerde Vücut Ağırlığının Değişimi. ADU Tıp Fakültesi Dergisi 2000;1:9-11.
Gawecka A, Michalkiewicz J, Kornacka MK, Luckiewicz B, Kubiszewska I. Immunologic properties differ in preterm infants fed olive oil vs soy-based lipid emulsions during parenteral nutrition. JPEN J Parenter Enteral Nutr. 2008 Jul-Aug;32(4):448-53. doi: 10.1177/0148607108319802.
PubMed 18596318
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Immunological Parameters and Growth of Olive Oil and Eoprotin Used as a Fortification Breast Milk at the VLBW Babies
- ClinicalTrials.gov ID
- NCT02832011
- Acronym / sponsor ID
- RDS / 2015-TF-U362
- Conditions
- Breast Milk Expression, Premature Birth of Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- nihat demirUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 13 Jul 2016 (estimated)
- 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.
This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged, below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin or olive-oil fortified breast milk. Cases will receive same amount of calorie intake either with eoprotin or olive oil fortified-breast milk. If investigators identify that olive oil doesn't increase proinflammatory cytokines and grant enough weight gain in premature infants at the end of the study, investigators will suggest olive oil to replace eoprotin which is a very costly breast milk-fortifier.
Detailed description
Low birth weight infants are premature infants that born with birth weight less than 1500 g. Because these infants have low birth weight, weight gain can be increased by fortifying breast milk after post-natal 7. day. Breast milk fortifiers might be preferred for very low birth weight or extremely low birth weight infants (infants with <1000 g birth weight infants) for faster weight gain. It does not increase risk of necrotizing enterocolitis or infection; and it has lower incidences of necrotizing enterocolitis and sepsis comparing to formula. Breast milk is usually fortified with 100 cc/kg/day enteral feeding (1,2,3,4). Even though many centers use olive oil to fortify breast milk for many years; there is no study to evaluate its scientific value. Hence it has been known that olive oil based parenteral nutrition solutions are well-tolerated by premature infants, are immunologically more neutral, does not increase proinflammatory cytokines; olive oil is the only fat consumed in its natural form and has antimicrobial and cytotoxic effects, lowers serum cholesterol concentration by decreasing cholesterol absorption, has protective measures against cardiovascular diseases due to antioxidant effects of ingredients such as mono- and poly-unsaturated fatty acids, phenolic substances, tocopherols and carotenoids; olive oil has antioxidant, cell renewal and anti- carcinogenic features because of containing squalene which is precursor of steroid synthesis and help digestion by increasing digestive juice by major pigments such as chlorophyll, pheophytin and chlorophyll (5).
In previous studies; it has been shown that nutritional support with parenteral olive oil emulsion has better plasma lipid content similarities to breast milk, lower proinflammatory cytokine synthesis, lower lipid peroxidation product levels, stronger T-cell response, higher E vitamin levels; and thus lower risk of nosocomial infections, SIRS (systemic inflammatory response syndrome), BPD (bronchopulmonary dysplasia), NEC (necrotizing enterocolitis), PVL (periventricular leukomalacia), ROP (retinopathy of prematurity) and cardiovascular diseases and positive impact on glucose metabolism. Participants hypothesize that oral olive oil intake will have similar effects (6).
Investigators aims to compare post-nutritional immunologic parameters of 1-28 day-aged 60 infants with <1500 g birth weight and < 32 weeks of gestational age who were fed with maternal milk that is fortified with eoprotin and olive oil and diagnosed and followed-up in Neonatal Intensive Care Unit of Pediatrics Department of Medicine Faculty of Yüzüncü Yıl University.
This study will be conducted on 60 patients who are 1-28 days-aged, below 1500-gram body weight, born before 32 weeks of gestational age and diagnosed and followed in Neonatal Unit of Pediatrics Department of Medicine Faculty of Yüzüncü Yıl University. For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, vials will be thawed in room temperature and serum TNF-alpha, IL-1 Beta, IL-6, IL-8, IL-10 levels will be analyzed with ELISA method by BIO-Tec ELx800 Absorbance Reader device and lipid profiles (LDL, HDL, Total cholesterol and triglyceride) and levels will be analyzed with spectrophotometric method by Architect ci16200; then these parameters will be compared with each other.
After feeding with olive oil infants will have received same amount of calorie with infants who will receive eoprotin-fortified breast milk. At the end of study, if participants identify that olive oil doesn't increase proinflammatory cytokines and provide enough weight gain in premature infants, investigators will suggest olive oil to replace eoprotin which is a very costly breast milk-fortifier. Investigators believe this situation will contribute to both country and family budgets.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olive oil | Active comparator | Dietary Supplement: olive oil, Dietary Supplement: EoprotinAfter randomization, Investigators will give human milk fortified with olive oil |
| Eoprotin | Active comparator | Dietary Supplement: olive oil, Dietary Supplement: EoprotinAfter randomization, Human milk fortified with Eoprotin according to the recommendations of the manufacturer (1g per 30ml milk) |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with <1500 g birth weight
- Infants with< 32 weeks of gestational age
- Infants who will be fed with maternal milk that is fortified with eoprotin and olive oil
Key exclusion criteria (4 listed)
- Critical ill patients
- Evident severe congenital malformation
- Intolerance of feeding
- Evident gastrointestinal malformation
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 oilAlso: Komili (extra virgin olive oil)The infants fed with olive oil will have received same amount of calorie with infants who will receive eoprotin-fortified breast milk. | Dietary supplement | Eoprotin, olive oil |
| EoprotinAlso: aptamilLow birth weight infants are premature infants that born with birth weight less than 1500 g. Because these infants have low birth weight, weight gain can be increased by fortifying breast milk after post-natal 7 with eoprotin. | Dietary supplement | Eoprotin, olive oil |
Primary outcome
serum alpha tumor necrosis factor will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed tumor necrosis factor alpha with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
IL-1 Beta will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-1 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
IL-6 will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-6 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
IL-8 will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-8 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
IL-10 will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-10 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;
Triglyceride will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed triglyceride with spectrophotometric method by Architect ci16200;
Total cholesterol will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed total cholesterol with spectrophotometric method by Architect ci16200;
Low density lipoprotein (LDL) will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed Low density lipoprotein (LDL) with spectrophotometric method by Architect ci16200;
High density lipoprotein (HDL) will be analyzed
Time frame: Within18 months
For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed High density lipoprotein (HDL) with spectrophotometric method by Architect ci16200;
6 secondary outcomes
SIRS (systemic inflammatory response syndrome)
Time frame: Within 3 months of life
Chronic Lung Disease (CLD)
Time frame: up to 36 weeks of post gestational age
Patent ductus arteriosus
Time frame: Within 5 days of life
Intraventricular haemorrhage
Time frame: Within 1 month of life
Necrotising enterocolitis
Time frame: Within 3 months of life
Retinopathy of prematurity (ROP)
Time frame: Up to 3 months of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Background1. Çelik HT, Yiğit Ş. Yenidoğan ve Prematüre Bebeklerde Parenteral Beslenmede Yenilikler. Hacettepe Tıp Dergisi 2009;40:176-189.
- Background2. Gülcan H. Preterm Yenidoğanlarda Parenteral Beslenmede Yenilikler. Gaziantep Tıp Dergisi 2010;16:66-74.
- Background3. Gürsoy T, Yurdakök M. Prematüre Bebeklerin Beslenmesi. Çocuk Sağlığı ve Hastalıkları Dergisi 2008;51:240-251.
- Background4. Ergin H, Kılıç İ, Gürses D, Sözeri A, Özdemir C. Zenginleştirilmiş Anne Sütü (Eoprotin) Alan Prematüre Bebeklerde Vücut Ağırlığının Değişimi. ADU Tıp Fakültesi Dergisi 2000;1:9-11.
- Results publication: PubMed 18596318Gawecka A, Michalkiewicz J, Kornacka MK, Luckiewicz B, Kubiszewska I. Immunologic properties differ in preterm infants fed olive oil vs soy-based lipid emulsions during parenteral nutrition. JPEN J Parenter Enteral Nutr. 2008 Jul-Aug;32(4):448-53. doi: 10.1177/0148607108319802.
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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.
nihat demir study director
Yuzuncu Yil University
Questions about this trial
What is this clinical trial studying?
A study testing olive oil and Eoprotin in people with Breast Milk Expression and Premature Birth of Newborn, run by nihat demir.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
serum alpha tumor necrosis factor will be analyzed (time frame: Within18 months). The study lists 9 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 NCT02832011, which also lists 5 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 13 Jul 2016.