Impaired Psychomotor DevelopmentPhase 1/2NCT02339727
Omega-6/Omega-3 Ratio and Neural Development in Preterm Infants.
A Phase 1/2 study testing Preterm infants formula in people with Impaired Psychomotor Development, run by Ayham alshweki.
Trial summary
It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are important in neurodevelopment of term and preterm infants. This study tried to determine the utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk formula, with a ratio similar to that found in… Read more about this study
- Who is it for?
- Ages 1 minute to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Psychomotor Development
- What is being tested?
- Preterm infants formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Sep 2014
- Phase
- Phase 1/2
- 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 minute to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent
Who cannot join
- Preterm infants with any malformation or deformation.
- Extreme preterm infants with gestational age less than 25 weeks.
- Infants whose parents couldn't follow up their children in our study center.
- Preterm infants who had a severe intra ventricular hemorrhage (more than grade 2).
- Premature infants who had severe periventricular leukomalacia (more than grade 2) because the latest two conditions can affect neurodevelopment.
- Finally, we excluded neonates who don't need supplementary milk nutrition, i.e. children with breastfeeding only.
About this study
Official title: Clinical Trial of the Relation Between Omega-6/Omega-3 Ratio in Formula of Preterm Infants Less Than 1500 Grams and/or Less Than 32 Weeks Gestational Ages and Brunet Lezine Score at 2 Years of Live. Anuvis Study
It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are important in neurodevelopment of term and preterm infants. This study tried to determine the utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate values of fatty acids they have in blood and psychomotor development they achieve.
Read the detailed description
The study took place in a single-center; it is a prospective randomized study of preterm infants less than 1500 grams and/or less than 32 weeks gestational age, admitted to the Neonatal Intensive Care Unit in the University Clinical Hospital of Santiago de Compostela. They were recruited for a period of 14 months (from July 2010 to august 2011) and followed from birth until 2 years of life.
40 children were included and followed in the study. Patients will be assigned randomly into two groups depending on the type of formula they are receiving. The group A of children will receive a formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2. And group B will receive other formula with DHA and ARA, but with a ratio of 1/1.
The classification of group A and B was made by simple random way; one birth in every group, continuously.
Implementation of breastfeeding will be promoted and will be fortified after 7 days of life, when the total amount of breast milk will be more than 1/2 of the total.
When breastfeeding will be insufficient or nonexistent, special formulas for premature babies will be given
During the follow-up of patients, will be measured:
- - Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months.The determination will be carried out in collaboration with the Hospital de Cruces, Bilbao, Spain.
- - Evaluation of psychomotor development by Brunet-Lezine scale at 2 years of corrected age.
- Conditions
- Impaired Psychomotor Development
- Being tested
- Preterm infants formula
- Keywords
- Omega-3, Omega-6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm infants formulaDietary supplement
The group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life. And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life.
| Study group | Role | What they receive |
|---|---|---|
| Omega-6/omega-3=2/1 milk formula | Active comparator | Preterm infants will receive a formulas supplemented with Docosahexaenoic acid and Arachidonic acid with a relationship omega 6/omega 3 = 2/1. Receives: Dietary Supplement: Preterm infants formula |
| Omega-6/omega-3=1/1 milk formula | Active comparator | preterm infants will receive other formulas with Docosahexaenoic acid and Arachidonic acid, but with a ratio of 1/1. Receives: Dietary Supplement: Preterm infants formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of fatty acids in blood
Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months of live
Measured: from July 2010 to august 2012 (from the birth to 1 years old)
Secondary outcomes (1)
Psychomotor development
Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.
Measured: from september 2012 to november 2013 (at two years of corrected age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJul 2010
- Primary completionNov 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Psychomotor DevelopmentStudies 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 1/2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayham alshweki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayham alshweki, Health Research Institute of Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339727
- Sponsor's protocol ID
- Ayham alshweki
- Status last verified
- Jan 2015
- First submitted
- 14 Nov 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Relation Between Omega-6/Omega-3 Ratio in Formula of Preterm Infants Less Than 1500 Grams and/or Less Than 32 Weeks Gestational Ages and Brunet Lezine Score at 2 Years of Live. Anuvis Study
- ClinicalTrials.gov ID
- NCT02339727
- Acronym / sponsor ID
- Ayham alshweki
- Conditions
- Impaired Psychomotor Development
- Keywords
- Omega-3, Omega-6
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ayham alshwekiUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Jan 2015 (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.
It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are important in neurodevelopment of term and preterm infants. This study tried to determine the utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate values of fatty acids they have in blood and psychomotor development they achieve.
Detailed description
The study took place in a single-center; it is a prospective randomized study of preterm infants less than 1500 grams and/or less than 32 weeks gestational age, admitted to the Neonatal Intensive Care Unit in the University Clinical Hospital of Santiago de Compostela. They were recruited for a period of 14 months (from July 2010 to august 2011) and followed from birth until 2 years of life.
40 children were included and followed in the study. Patients will be assigned randomly into two groups depending on the type of formula they are receiving. The group A of children will receive a formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2. And group B will receive other formula with DHA and ARA, but with a ratio of 1/1.
The classification of group A and B was made by simple random way; one birth in every group, continuously.
Implementation of breastfeeding will be promoted and will be fortified after 7 days of life, when the total amount of breast milk will be more than 1/2 of the total.
When breastfeeding will be insufficient or nonexistent, special formulas for premature babies will be given
During the follow-up of patients, will be measured:
- - Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months.The determination will be carried out in collaboration with the Hospital de Cruces, Bilbao, Spain.
- - Evaluation of psychomotor development by Brunet-Lezine scale at 2 years of corrected age.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-6/omega-3=2/1 milk formula | Active comparator | Dietary Supplement: Preterm infants formulaPreterm infants will receive a formulas supplemented with Docosahexaenoic acid and Arachidonic acid with a relationship omega 6/omega 3 = 2/1. |
| Omega-6/omega-3=1/1 milk formula | Active comparator | Dietary Supplement: Preterm infants formulapreterm infants will receive other formulas with Docosahexaenoic acid and Arachidonic acid, but with a ratio of 1/1. |
Who may qualify
- Ages
- 1 minute to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Living infants who were less than 1500 grams and/or less than 32 weeks gestational age, and whose parents accepted and subscribed the informed consent
Key exclusion criteria (6 listed)
- Preterm infants with any malformation or deformation.
- Extreme preterm infants with gestational age less than 25 weeks.
- Infants whose parents couldn't follow up their children in our study center.
- Preterm infants who had a severe intra ventricular hemorrhage (more than grade 2).
- Premature infants who had severe periventricular leukomalacia (more than grade 2) because the latest two conditions can affect neurodevelopment.
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 |
|---|---|---|
| Preterm infants formulaThe group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life. And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life. | Dietary supplement | Omega-6/omega-3=1/1 milk formula, Omega-6/omega-3=2/1 milk formula |
Primary outcome
Levels of fatty acids in blood
Time frame: from July 2010 to august 2012 (from the birth to 1 years old)
Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12 months of live
1 secondary outcome
Psychomotor development
Time frame: from september 2012 to november 2013 (at two years of corrected age)
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 15 Jan 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Preterm infants formula in people with Impaired Psychomotor Development, run by Ayham alshweki.
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 1 inclusion and 6 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 15 Jan 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Levels of fatty acids in blood (time frame: from July 2010 to august 2012 (from the birth to 1 years old)). 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 15 Jan 2015.