Premature InfantsNCT01140243
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
A study testing LCPUFA in people with Premature Infants, run by Materna Laboratories at 2 sites in Israel.
Trial summary
The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital. Read more about this study
- Who is it for?
- Ages 2 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infants
- What is being tested?
- LCPUFA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2010to Mar 2013
- 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 2 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
- whose mothers are unable to breast feed or have chosen not to breast feed,
- Whose parents have signed the informed consent form.
- Only the first among twins will be recorded for the study.
Who cannot join
- Chromosomal abnormalities or congenital malformation.
- Metabolic abnormalities.
- Central nervous system abnormalities.
- Severe developmental disorders.
- GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
- Milk allergy or intolerance.
- Growth failure.
- Chronic disease
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Neonatal Intensive Care Unit, Barzilai Medical Center
Ashkelon
Sharei Zedek MC
Jerusalem
About this study
Official title: Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital
The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.
- Conditions
- Premature Infants
- Being tested
- LCPUFA
- Keywords
- fat formulation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCPUFADietary supplement
premature infant formula supplemented with LCPUFA
| Study group | Role | What they receive |
|---|---|---|
| test product | Experimental | Dietary supplement Receives: Dietary Supplement: LCPUFA |
| standart | Active comparator | Dietary supplement Receives: Dietary Supplement: LCPUFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
anthropometric
anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materna Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140243
- Sponsor's protocol ID
- 030
- Status last verified
- Apr 2012
- First submitted
- 8 Jun 2010
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital
- ClinicalTrials.gov ID
- NCT01140243
- Acronym / sponsor ID
- 030
- Conditions
- Premature Infants
- Keywords
- fat formulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Materna LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Jun 2010 (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.
The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test product | Experimental | Dietary Supplement: LCPUFADietary supplement |
| standart | Active comparator | Dietary Supplement: LCPUFADietary supplement |
Who may qualify
- Ages
- 2 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
- whose mothers are unable to breast feed or have chosen not to breast feed,
- Whose parents have signed the informed consent form.
- Only the first among twins will be recorded for the study.
Key exclusion criteria (8 listed)
- Chromosomal abnormalities or congenital malformation.
- Metabolic abnormalities.
- Central nervous system abnormalities.
- Severe developmental disorders.
- GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
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 |
|---|---|---|
| LCPUFApremature infant formula supplemented with LCPUFA | Dietary supplement | standart, test product |
Primary outcome
anthropometric
Time frame: 12 weeks
anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks
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 29 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCPUFA in people with Premature Infants, run by Materna Laboratories at 2 sites in Israel.
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 4 inclusion and 8 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
anthropometric (time frame: 12 weeks). 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 29 May 2013.