Impaired Psychomotor DevelopmentPhase 2NCT02503020
Arachidonic Acid Supplementation in Very Preterm Infants
A Phase 2 study testing Preterm infants formula A and Preterm infants formula B in people with Impaired Psychomotor Development, run by Health Research Institute of Santiago.
Trial summary
Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual… 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 A and Preterm infants formula B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Mar 2015
- Phase
- Phase 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 severe malformation.
- Extremely preterm infants with a gestational age of less than 25 weeks.
- Infants whose parents could not complete the follow-up process in our study center.
- Preterm infants with severe intraventricular hemorrhage or periventricular leukomalacia (more than grade 2).
- Neonates who did not need supplementary milk nutrition, i.e. breastfed-only children.
About this study
Official title: Effects of Different Arachidonic Acid Supplementation on Psychomotor Development in Very Preterm Infants, a Randomized Controlled Trial
Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual and cognitive development.
In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor development in very preterm infants who had diets supplemented with different LCPUFA amount of AA to support the importance of sufficient AA values in formula.
Read the detailed description
the investigators carried out a prospective randomized controlled double blinded trial in order to study nutritional supplements for preterm infants <1500 grams and/or <32 weeks gestational age (GA) who were born in clinical University Hospital of Santiago de Compostela (CHUS). They were enrolled for a period of 14 months (from July 2011 to August 2012) and followed up from birth until 2 years of age. Milk formulas were provided either as adjunct to insufficient amount of breast milk, or as full formula feeding. Breastfeeding was actively encouraged. Patients were randomized into one of the two formula groups, depending on the type of formula they were to receive. Group A's formula was supplemented with DHA (0.3% of all fatty acids) and AA (0.6%) with an ω-6/ω-3 ratio of 2/1. Group B's formula was supplemented with DHA (0.3%) and AA (0.3%) with an ω-6/ω-3 ratio of 1/1.
Primary outcome:
Assessment of psychomotor development with the Brunet Lézine scale at 2 years of age (Early Care Unit CHUS)
Secondary outcomes:
Physical examination and anthropometric measurements (weight, length, and head circumference) at birth and at 3, 6, 9, 12, 18, and 24 months of age (Neonatology Unit CHUS) Blood levels of fatty acids in the first week of life and at 3 months, 6 months, and 12 months. (Metabolic Unit. Hospital de Cruces, Bilbao) Visual- and auditory-evoked potentials at 6 and 12 months of age (Neurophysiology Unit CHUS)
- Conditions
- Impaired Psychomotor Development
- Being tested
- Preterm infants formula A, Preterm infants formula B
- Keywords
- Arachidonic acid, Omega-6/omega-3 ratio, Preterm infants nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm infants formula ADietary supplement
Group A will receive a preterm infants formula supplemented with AA (0.6%) and DHA (0.3%) until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (2/1) until one year corrected age.
Preterm infants formula BDietary supplement
Group B will receive other Preterm infants formula very similar, but with AA (0.3%) and DHA (0.3%) also until they have three months corrected age.
At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (1/1) until one year corrected age.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Preterm infants formula A Pretarm infants were fed on formula with Arachidonic acid (0.6%) and Docosahexaenoic acid (0.3%) Receives: Dietary Supplement: Preterm infants formula A |
| Group B | Active comparator | Preterm infants formula B Pretarm infants were fed on formula with Arachidonic acid (0.3%) and Docosahexaenoic acid (0.3%) Receives: Dietary Supplement: Preterm infants formula B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor development
Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.
Measured: From september 2013 to november 2014 (at two years of corrected age)
Secondary outcomes (5)
Levels of fatty acids in plasma
Blood samples were obtained from study children to study the levels of fatty acids in plasma at 3 , 6 and 12 months of life
Measured: From october 2011 to november 2013 (from 3 months to 1 years old)
Visual- and auditory-evoked potentials
Visual- and auditory-evoked potentials were studied with special scale at 6 and 12 months of life
Measured: From january 2012 to February 2013 (from 6 months to 1 years old)
Weight
Weight at 3, 6, 9, 12, 18, and 24 months of life
Measured: From october 2011 to november 2014 (from 6 months to 2 years old)
Length
Length at 3, 6, 9, 12, 18, and 24 months of life
Measured: From october 2011 to november 2014 (from 6 months to 2 years old)
Head circumference
Head circumference at 3, 6, 9, 12, 18, and 24 months of life
Measured: From october 2011 to november 2014 (from 6 months to 2 years old)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Research Institute of Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayham alshweki, Health Research Institute of Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503020
- Sponsor's protocol ID
- Ayham
- Status last verified
- Jul 2015
- First submitted
- 14 Jul 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Alshweki A, Munuzuri AP, Bana AM, de Castro MJ, Andrade F, Aldamiz-Echevarria L, de Pipaon MS, Fraga JM, Couce ML. Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial. Nutr J. 2015 Sep 30;14:101. doi: 10.1186/s12937-015-0091-3.
PubMed 26424477
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Arachidonic Acid Supplementation on Psychomotor Development in Very Preterm Infants, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02503020
- Acronym / sponsor ID
- Ayham
- Conditions
- Impaired Psychomotor Development
- Keywords
- Arachidonic acid, Omega-6/omega-3 ratio, Preterm infants nutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Health Research Institute of SantiagoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Jul 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.
Long-chain polyunsaturated fatty acids (LCPUFAs), arachidonic acid (AA omega-6; 20:4ω-6), and docosahexaenoic acid (DHA omega-3; 22:6ω-3), are required for the formation of non-myelinated cell membranes in the central nervous system, including in the retina, hence the great importance of them for appropriate visual and cognitive development.
In this study, the investigators assessed anthropometric, visual, auditory, and psychomotor development in very preterm infants who had diets supplemented with different LCPUFA amount of AA to support the importance of sufficient AA values in formula.
Detailed description
the investigators carried out a prospective randomized controlled double blinded trial in order to study nutritional supplements for preterm infants <1500 grams and/or <32 weeks gestational age (GA) who were born in clinical University Hospital of Santiago de Compostela (CHUS). They were enrolled for a period of 14 months (from July 2011 to August 2012) and followed up from birth until 2 years of age. Milk formulas were provided either as adjunct to insufficient amount of breast milk, or as full formula feeding. Breastfeeding was actively encouraged. Patients were randomized into one of the two formula groups, depending on the type of formula they were to receive. Group A's formula was supplemented with DHA (0.3% of all fatty acids) and AA (0.6%) with an ω-6/ω-3 ratio of 2/1. Group B's formula was supplemented with DHA (0.3%) and AA (0.3%) with an ω-6/ω-3 ratio of 1/1.
Primary outcome:
Assessment of psychomotor development with the Brunet Lézine scale at 2 years of age (Early Care Unit CHUS)
Secondary outcomes:
Physical examination and anthropometric measurements (weight, length, and head circumference) at birth and at 3, 6, 9, 12, 18, and 24 months of age (Neonatology Unit CHUS) Blood levels of fatty acids in the first week of life and at 3 months, 6 months, and 12 months. (Metabolic Unit. Hospital de Cruces, Bilbao) Visual- and auditory-evoked potentials at 6 and 12 months of age (Neurophysiology Unit CHUS)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: Preterm infants formula APreterm infants formula A Pretarm infants were fed on formula with Arachidonic acid (0.6%) and Docosahexaenoic acid (0.3%) |
| Group B | Active comparator | Dietary Supplement: Preterm infants formula BPreterm infants formula B Pretarm infants were fed on formula with Arachidonic acid (0.3%) and Docosahexaenoic acid (0.3%) |
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 (5 listed)
- Preterm infants with any severe malformation.
- Extremely preterm infants with a gestational age of less than 25 weeks.
- Infants whose parents could not complete the follow-up process in our study center.
- Preterm infants with severe intraventricular hemorrhage or periventricular leukomalacia (more than grade 2).
- Neonates who did not need supplementary milk nutrition, i.e. breastfed-only children.
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 formula AGroup A will receive a preterm infants formula supplemented with AA (0.6%) and DHA (0.3%) until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (2/1) until one year corrected age. | Dietary supplement | Group A |
| Preterm infants formula BGroup B will receive other Preterm infants formula very similar, but with AA (0.3%) and DHA (0.3%) also until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (1/1) until one year corrected age. | Dietary supplement | Group B |
Primary outcome
Psychomotor development
Time frame: From september 2013 to november 2014 (at two years of corrected age)
Evaluation of psychomotor development by making Brunet-Lezine scale at 2 years of corrected age.
5 secondary outcomes
Levels of fatty acids in plasma
Time frame: From october 2011 to november 2013 (from 3 months to 1 years old)
Visual- and auditory-evoked potentials
Time frame: From january 2012 to February 2013 (from 6 months to 1 years old)
Weight
Time frame: From october 2011 to november 2014 (from 6 months to 2 years old)
Length
Time frame: From october 2011 to november 2014 (from 6 months to 2 years old)
Head circumference
Time frame: From october 2011 to november 2014 (from 6 months to 2 years old)
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 20 Jul 2015.
- Derived from this study: PubMed 26424477Alshweki A, Munuzuri AP, Bana AM, de Castro MJ, Andrade F, Aldamiz-Echevarria L, de Pipaon MS, Fraga JM, Couce ML. Effects of different arachidonic acid supplementation on psychomotor development in very preterm infants; a randomized controlled trial. Nutr J. 2015 Sep 30;14:101. doi: 10.1186/s12937-015-0091-3.
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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 2 study testing Preterm infants formula A and Preterm infants formula B in people with Impaired Psychomotor Development, run by Health Research Institute of Santiago.
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 5 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 20 Jul 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 phase mean?
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?
Psychomotor development (time frame: From september 2013 to november 2014 (at two years of corrected age)). 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 NCT02503020, which also lists 1 linked publication.
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 20 Jul 2015.