Conventional IVLE (Intralipid) from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.

n3-LCPUFA enriched IVLE (SMOFlipid) from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.

Very Low Birth Weight Infant

Bronchopulmonary Dysplasia

To start from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.

n3-LCPUFA enriched Intravenous Lipid Emulsion

Foothills Medical Centre

SMOFlipid and Incidence of BPD in Preterm Infants

Does Parenteral Omega-3 Enriched Lipid Emulsion Reduce Incidence of Bronchopulmonary Dysplasia in Preterm Infants

According to Child Health and Human Development with classification to mild, moderate and severe.

Determine serum fatty acids levels (μmol/L).

Compare pro-inflammatory cytokine levels (pg/mL)

Defined as stage 2 or higher according to the international classification or requiring treatment.

Defined by 1 or more of the following: moderate to severe motor impairment cerebral palsy (CP) or non-CP) with a GMFCS level ≥2, a BSID III cognitive score of <70, severe visual impairment (bilateral blindness with vision <20/200), or severe hearing impairment (permanent hearing loss that interferes with ability to understand or communicate with or without amplification).

Belal Alshaikh

Clinical Assistant Professor of Pediatrics

University of Calgary

The experimental group will receive a parenteral emulsion containing soy oil, MCT, olive oil and n-3 LCPUFA in fish oil

The Control group will receive a parenteral emulsion containing soy oil and MCT

Pulmonary Hypertension of Newborn

Diaphragm Defect

TPN will start at 2.0 g/kg/d of the lipid emulsion, increasing 1.0 g/kg/d until a maximum of 4.0 g/kg/d for at least 14 days.

Parenteral emulsion

Unit of Medical Research in Nutrition

Effect of a Parenteral Emulsion With Omega3 on PPHN

Effect of a Parenteral Emulsion Parenteral With Long-chain Polyunsaturated Fatty Acids Omega 3 on Clinical Outcomes, Inflammatory and Oxidative Stress Markers in Neonates With Persistent Pulmonary Hypertension

measured by echocardiography in millimeters of mercury (mm/Hg)

Measure the amount of oxygen in blood measured by gasometry in arterial blood in mmHg

It is a measure of oxygenation in hemoglobin. It is preductal if the measurement id on hand, and postductal if it is on foot, determined by an pulse oximeter in percentage

Oxygen concentration supplied by ventilation support in percentage

Measurement of body weight in grams, length and head circumference in centimeters to obtain an eutrophic or undernutrition outcome using the Fenton's standard reference of growth and/or World Health Organization as appropriate for preterm or term infants, respectively.

Pain will be measured with COMFORT scale computed by the sum of 8 sections with scores from 1 to 5. The sum will be scored as mild (<10 points), moderate (10-20 points) and severe (>20 points)

Determination of pro and anti-inflammatory cytokines interleukin (IL)-1beta, tumoral necrosis factor-alpha, IL-6, IL-8, IL-10, IL-12 (p70) (pg/milliliter) in plasma by luminex-based immunoassay.

Determination lipid mediators such as eicosanoids and resolvin(s) in ng/ml by liquid chromatography coupled to mass spectrometry.

This will be measured in urine by ELISA in pg/milliliter

This will be measured in urine by ELISA in micromol per liter (uM)

This will be measured in urine by ELISA in uM/milliliter

This ratio will be measured in urine in nmol/liter by Liquid chromatography coupled to mass spectrometry.

Mariela Bernabe García

Full time researcher

Coordinación de Investigación en Salud, Mexico

Use of a parenteral emulsion that is used as routine nutrition for newborns but not evaluated for persistent pulmonary hypertension.

The attendant gastroenterologist has a randomized allocation and will indicate the type of emulsion during the recruitment. Each emulsion will be designed as a code A or B. The code for each patient is stored into an opaque envelop, which is opened once the parents have given their written informed consent.

After randomization, Investigators will give human milk fortiﬁed with olive oil

After randomization, Human milk fortiﬁed with Eoprotin according to the recommendations of the manufacturer (1g per 30ml milk)

Breast Milk Expression

Premature Birth of Newborn

The infants fed with olive oil will have received same amount of calorie with infants who will receive eoprotin-fortified breast milk.

olive oil

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.

Eoprotin

How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth

The Effect on Immunological Parameters and Growth of Olive Oil and Eoprotin Used as a Fortification Breast Milk at the VLBW Babies

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 ;

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 ;

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 ;

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 ;

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 ;

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;

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;

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;

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;

will be defined according to National Institutes of Health criteria.

Chronic Lung Disease (CLD) will be defined according to National Institutes of Health criteria.

Echocardiography will be performed routinely for patent ductus arteriosus within 5 days of life

We will assess for intraventricular haemorrhage higher than grade II using the Papile classification system

Necrotising enterocolitis with the modified Bell's classification system

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.

nihat demir

Principal Investigator

Infants randomized to the cream supplement group will receive an exclusive HM-based diet with the addition of a HM-derived cream caloric supplement.

Infants randomized to the Control group will receive the standard regimen of an exclusive HM-based diet (no cream supplement).

Infants in the intervention arm will receive the cream supplement in addition to the standard regimen.

Cream Supplement group

Orlando Health, Inc. - Winnie Palmer Hospital for Women and Babies

Michigan State University

Children's Hospital Medical Center of Akron

Cook Children's Medical Center

Baylor College of Medicine / Texas Children's Hospital

University of Texas Health Science Center at San Antonio

Wasatch Neonatal

University Hospital

Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants

Post-Discharge Evaluation of Human Milk Cream Study Infants at 18 to 24 Month CGA: A Randomized Trial of the Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants

The primary endpoint for the study is the difference in length of hospital stay (days) between the two groups from birth until discharge or removal from the study (due to transfer to non-study institution or death), whichever comes first.

The secondary endpoint is to evaluate if Infants who have BPD and receive the cream supplement will be discharged home at an earlier postmenstrual age compared to infants with BPD who do not receive the cream supplement.

bronchopulmonary dysplasia/triglyceride

SMOFlipid and Incidence of BPD in Preterm Infants

Effect of a Parenteral Emulsion With Omega3 on PPHN

How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth

Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants

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