Preterm NeonatesPhase 4SMOFNCT02853253
Rate of Bronchopulmonary Dysplasia in Preterms Neonates: a Trial Comparing SMOFlipid and Medialipide
A Phase 4 study testing SMOFlipid® and Medialipide® in people with Preterm Neonates, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. Read more about this study
- Who is it for?
- Ages 6 hours to 1 day
- Conditions the study is for
- Preterm Neonates
- What is being tested?
- SMOFlipid® and Medialipide®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to May 2019
- Phase
- Phase 4
- 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 6 hours to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates with gestational age < 29 weeks and / or birth weight < 1000 g
- Admission in the Intensive Care Unit within 6 h after birth
- IV Lipid Emulsion (LE) started latest at first day of life
- Anticipated duration of Parenteral Nutrition >10 days
- Informed consent from legal representative
Who cannot join
- Inherited metabolic diseases
- Major congenital malformations
- Participation to another study evaluating any kind of medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rate of Bronchopulmonary Dysplasia in Preterms Neonates Less Than 29 Weeks' Gestational Age and / or With Birth Weight Less Than 1000 g: a Double Blind Randomized Controlled Multicenter Trial Comparing SMOFlipid and Medialipide
SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.
- Conditions
- Preterm Neonates
- Being tested
- SMOFlipid®, Medialipide®
- Keywords
- Preterm neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFlipid®Dietary supplement
SMOFlipid® (FreseniusKabi France, Sèvres, France). It is a 3rd generation LE containing a physical mixture of soybean oil (30%), MCT (30%), olive oil (25%) and fish oil (15%). Its ratio omega6/omega 3 is 2,5/1. SMOF will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day; daily increase: 0.5 to 1 g/kg/day ; target: 3 to 4 g/kg/day.
All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively.
Medialipide®Dietary supplement
Medialipide® 20% (B Braun Medical, Boulogne, France). It is a second generation LE containing soybean oil (50%) and MCT (50%). Its ratio omega6/omega 3 is 7/4. Medialipide will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day ; daily increase: 0.5 to 1 g/kg/day; target: 3 to 4 g/kg/day.
All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively.
| Study group | Role | What they receive |
|---|---|---|
| SMOF | Experimental | parenteral nutrition using SMOFlipid® (FreseniusKabi France, Sèvres, France) Receives: Dietary Supplement: SMOFlipid® |
| Medialipide® | Active comparator | parenteral nutrition using Medialipide® 20% (B Braun Medical, Boulogne, France) Receives: Dietary Supplement: Medialipide® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of other free radical diseases
Free radical diseases include: intraventricular hemorrhage (IVH) > grade II, retinopathy of prematurity (ROP) > grade II, and necrotizing enterocolitis (NEC) > grade IA (Bell classification).
Measured: 36 weeks corrected age
Secondary outcomes (6)
Weight gain
Weight gain in g/kg/j according to the following formulae: 1000 * ((weight on day 28 or week 36 - birth weight)/((weight on day 28 or week 36 + birth weight)/2)) / number of days
Measured: at day 28
Weight gain
Weight gain in g/kg/j according to the following formulae: 1000 * ((weight on day 28 or week 36 - birth weight)/((weight on day 28 or week 36 + birth weight)/2)) / number of days
Measured: week 36 corrected age
Growth velocity
Length growth velocity in cm/week at day 28 according to the following formulae: (length on day 28 - length at birth) / number of weeks
Measured: at day 28
Growth velocity
Length growth velocity in cm/week at week 36 corrected age according to the following formulae: (length on week 36 - length at birth) / number of weeks
Measured: week 36 corrected age
Head circumference growth velocity
Head circumference growth velocity in cm/week according to the following formulae: (head circumference on day 28 - head circumference at birth) / number of weeks
Measured: at day 28
Head circumference growth velocity
Head circumference growth velocity in cm/week according to the following formulae: (head circumference on week 36 - head circumference at birth) / number of weeks
Measured: at week 36 corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: scientific question reconsidered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm NeonatesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier CLARIS, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853253
- Sponsor's protocol ID
- 69HCL16_0135
- Acronym
- SMOF
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Bronchopulmonary Dysplasia in Preterms Neonates Less Than 29 Weeks' Gestational Age and / or With Birth Weight Less Than 1000 g: a Double Blind Randomized Controlled Multicenter Trial Comparing SMOFlipid and Medialipide
- ClinicalTrials.gov ID
- NCT02853253
- Acronym / sponsor ID
- SMOF / 69HCL16_0135
- Conditions
- Preterm Neonates
- Keywords
- Preterm neonates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: scientific question reconsidered
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 2 Aug 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.
SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMOF | Experimental | Dietary Supplement: SMOFlipid®parenteral nutrition using SMOFlipid® (FreseniusKabi France, Sèvres, France) |
| Medialipide® | Active comparator | Dietary Supplement: Medialipide®parenteral nutrition using Medialipide® 20% (B Braun Medical, Boulogne, France) |
Who may qualify
- Ages
- 6 hours to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm neonates with gestational age < 29 weeks and / or birth weight < 1000 g
- Admission in the Intensive Care Unit within 6 h after birth
- IV Lipid Emulsion (LE) started latest at first day of life
- Anticipated duration of Parenteral Nutrition >10 days
- Informed consent from legal representative
Key exclusion criteria (3 listed)
- Inherited metabolic diseases
- Major congenital malformations
- Participation to another study evaluating any kind of medications
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 |
|---|---|---|
| SMOFlipid®SMOFlipid® (FreseniusKabi France, Sèvres, France). It is a 3rd generation LE containing a physical mixture of soybean oil (30%), MCT (30%), olive oil (25%) and fish oil (15%). Its ratio omega6/omega 3 is 2,5/1. SMOF will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day; daily increase: 0.5 to 1 g/kg/day ; target: 3 to 4 g/kg/day. All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively. | Dietary supplement | SMOF |
| Medialipide®Medialipide® 20% (B Braun Medical, Boulogne, France). It is a second generation LE containing soybean oil (50%) and MCT (50%). Its ratio omega6/omega 3 is 7/4. Medialipide will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day ; daily increase: 0.5 to 1 g/kg/day; target: 3 to 4 g/kg/day. All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively. | Dietary supplement | Medialipide® |
Primary outcome
Rate of other free radical diseases
Time frame: 36 weeks corrected age
Free radical diseases include: intraventricular hemorrhage (IVH) > grade II, retinopathy of prematurity (ROP) > grade II, and necrotizing enterocolitis (NEC) > grade IA (Bell classification).
6 secondary outcomes
Weight gain
Time frame: at day 28
Weight gain
Time frame: week 36 corrected age
Growth velocity
Time frame: at day 28
Growth velocity
Time frame: week 36 corrected age
Head circumference growth velocity
Time frame: at day 28
Head circumference growth velocity
Time frame: at week 36 corrected age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Preterm Neonates
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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.
Olivier CLARIS, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SMOFlipid® and Medialipide® in people with Preterm Neonates, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Jul 2019. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of other free radical diseases (time frame: 36 weeks corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2019.