Infant DevelopmentCOGNISNCT02094547
A Neurocognitive and Immunological Study of a New Formula for Healthy Infants
A study testing New infant formula, Standard infant formula and Breastfeeding in people with Infant Development, run by Laboratorios Ordesa at 1 site in Spain.
Trial summary
To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula. Read more about this study
- Who is it for?
- Ages 1 day to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- New infant formula, Standard infant formula and Breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2010to Oct 2020
- 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 1 day to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term newborns (>37 weeks and <41 weeks gestation)
- Adequate birth weight for his gestational age (between 3-97 percentiles)
- Inclusion age: from 0 to 2 months (60 days) in the formula fed groups
- Inclusion age: 2-6 months (180 days) in the breastfeeding group
- Maximum 30 days of exclusive breastfeeding in the formula fed groups
- From 30 days on, exclusive or >70% infant formula in the formula fed groups
Show all 10Show fewer
- Normal Apgar score: 7-10
- Umbilical pH ≥ of 7.10
- Availability to continue during the whole study period
- Informed consent signed ( parent/legal representative)
Who cannot join
- Participating in other studies.
- Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...).
- Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance)
- Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex.
- Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' neurodevelopment.
- Infant's family who in the investigators assessment cannot be expected to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes
To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.
- Conditions
- Infant Development
- Being tested
- New infant formula, Standard infant formula, Breastfeeding
- Keywords
- Infant Formula, Cognition, Neurodevelopment, Immunity, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New infant formulaDietary supplement
New infant formula
Standard infant formulaDietary supplement
Standard infant formula
BreastfeedingDietary supplement
Exclusive breastfeeding or less tan 25% formula intake
| Study group | Role | What they receive |
|---|---|---|
| New infant formula | Experimental | New infant formula with key ingredients. Receives: Dietary Supplement: New infant formula |
| Standard infant formula | Active comparator | Standard infant formula Receives: Dietary Supplement: Standard infant formula |
| Breastfeeding | Other | Control Receives: Dietary Supplement: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Development
Differences in neurocognitive development inter and intragroup evaluated by visual evoked potential test, general movements test, BAYLEY'S III test, MacArthur test, behavior assessment and cognitive evoked potential test (EEG/ERP).
Measured: At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months.
Neurocognitive Development at 4 and 6 years
Differences in neurocognitive development evaluated by Computarized battery for neuropsychological evaluation of children, Kaufman Brief Intellligence Test, Language test of Navarre,functional exploration, behavior assessment, questionnaires and cognitive evoked potential test (EEG/ERP).
Measured: At 4 and 6 years of age
Neurocognitive Development at 6 years
Functional Magnetic Resonance Image
Measured: At 6 years of age
Secondary outcomes (8)
Formula Tolerability
Evaluation of gastrointestinal symptoms and sleep disorders amongst groups.
Measured: At 2nd, 3rd, 4th, 6th, 12th and 18th months.
Growth
Differences in growth parameters (weight, length, BMI, skin folds, perimeters and z-scores) between groups.
Measured: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
Incidence of infections
Number of infections reported.
Measured: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
Immunoglobulin A secretor (IgAs) levels
Inter and intragroup differences measured by saliva samples analysis.
Measured: At 3rd, 6th, 12th,18th month, and 4 years old.
Impact on microbiota
Changes in microbiota composition measured by real-time polymerase chain reaction (RT-PCR) in faeces.
Measured: At 3rd, 6th, 12th and 18th months; 4 and 6 years of age.
Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels
Differences in LC-PUFAS levels inter and intragroup evaluated by oral mucosa samples analysis.
Measured: At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.
Cardiovascular factors
Blood pressure measurement
Measured: At 4 and 6 years old
Glucose monitoring
Urine metabolomic analysis
Measured: At 6 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startDec 2010
- Primary completionMar 2016
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infant 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cristina Campoy, Professor, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094547
- Sponsor's protocol ID
- FC0G - 010
- Acronym
- COGNIS
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2014
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dieguez E, Nieto-Ruiz A, Martin-Perez C, Sepulveda-Valbuena N, Herrmann F, Jimenez J, De-Castellar R, Catena A, Garcia-Santos JA, Bermudez MG, Campoy C. Association study between hypothalamic functional connectivity, early nutrition, and glucose levels in healthy children aged 6 years: The COGNIS study follow-up. Front Nutr. 2022 Oct 12;9:935740. doi: 10.3389/fnut.2022.935740. eCollection 2022.
PubMed 36313089Cerdo T, Ruiz A, Acuna I, Nieto-Ruiz A, Dieguez E, Sepulveda-Valbuena N, Escudero-Marin M, Garcia-Santos JA, Garcia-Ricobaraza M, Herrmann F, Moreno-Munoz JA, De Castellar R, Jimenez J, Suarez A, Campoy C. A synbiotics, long chain polyunsaturated fatty acids, and milk fat globule membranes supplemented formula modulates microbiota maturation and neurodevelopment. Clin Nutr. 2022 Aug;41(8):1697-1711. doi: 10.1016/j.clnu.2022.05.013. Epub 2022 May 23.
PubMed 35777109Nieto-Ruiz A, Garcia-Santos JA, Verdejo-Roman J, Dieguez E, Sepulveda-Valbuena N, Herrmann F, Cerdo T, De-Castellar R, Jimenez J, Bermudez MG, Perez-Garcia M, Miranda MT, Lopez-Sabater MC, Catena A, Campoy C. Infant Formula Supplemented With Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids, and Synbiotics Is Associated With Neurocognitive Function and Brain Structure of Healthy Children Aged 6 Years: The COGNIS Study. Front Nutr. 2022 Mar 9;9:820224. doi: 10.3389/fnut.2022.820224. eCollection 2022.
PubMed 35356726Sepulveda-Valbuena N, Nieto-Ruiz A, Dieguez E, Herrmann F, Escudero-Marin M, De-Castellar R, Rodriguez-Palmero M, Miranda MT, Garcia-Santos JA, Bermudez MG, Campoy C. Growth patterns and breast milk/infant formula energetic efficiency in healthy infants up to 18 months of life: the COGNIS study. Br J Nutr. 2021 Dec 28;126(12):1809-1822. doi: 10.1017/S000711452100057X. Epub 2021 Feb 19.
PubMed 33602357
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes
- ClinicalTrials.gov ID
- NCT02094547
- Acronym / sponsor ID
- COGNIS / FC0G - 010
- Conditions
- Infant Development
- Keywords
- Infant Formula, Cognition, Neurodevelopment, Immunity, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2020 (estimated)
- First posted
- 24 Mar 2014 (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.
To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New infant formula | Experimental | Dietary Supplement: New infant formulaNew infant formula with key ingredients. |
| Standard infant formula | Active comparator | Dietary Supplement: Standard infant formulaStandard infant formula |
| Breastfeeding | Other | Dietary Supplement: BreastfeedingControl |
Who may qualify
- Ages
- 1 day to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Full-term newborns (>37 weeks and <41 weeks gestation)
- Adequate birth weight for his gestational age (between 3-97 percentiles)
- Inclusion age: from 0 to 2 months (60 days) in the formula fed groups
- Inclusion age: 2-6 months (180 days) in the breastfeeding group
- Maximum 30 days of exclusive breastfeeding in the formula fed groups
Key exclusion criteria (6 listed)
- Participating in other studies.
- Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...).
- Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance)
- Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex.
- Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' 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 |
|---|---|---|
| New infant formulaNew infant formula | Dietary supplement | New infant formula |
| Standard infant formulaStandard infant formula | Dietary supplement | Standard infant formula |
| BreastfeedingExclusive breastfeeding or less tan 25% formula intake | Dietary supplement | Breastfeeding |
Primary outcome
Neurocognitive Development
Time frame: At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months.
Differences in neurocognitive development inter and intragroup evaluated by visual evoked potential test, general movements test, BAYLEY'S III test, MacArthur test, behavior assessment and cognitive evoked potential test (EEG/ERP).
Neurocognitive Development at 4 and 6 years
Time frame: At 4 and 6 years of age
Differences in neurocognitive development evaluated by Computarized battery for neuropsychological evaluation of children, Kaufman Brief Intellligence Test, Language test of Navarre,functional exploration, behavior assessment, questionnaires and cognitive evoked potential test (EEG/ERP).
Neurocognitive Development at 6 years
Time frame: At 6 years of age
Functional Magnetic Resonance Image
8 secondary outcomes
Formula Tolerability
Time frame: At 2nd, 3rd, 4th, 6th, 12th and 18th months.
Growth
Time frame: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
Incidence of infections
Time frame: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
Immunoglobulin A secretor (IgAs) levels
Time frame: At 3rd, 6th, 12th,18th month, and 4 years old.
Impact on microbiota
Time frame: At 3rd, 6th, 12th and 18th months; 4 and 6 years of age.
Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels
Time frame: At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.
Cardiovascular factors
Time frame: At 4 and 6 years old
Glucose monitoring
Time frame: At 6 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 36313089Dieguez E, Nieto-Ruiz A, Martin-Perez C, Sepulveda-Valbuena N, Herrmann F, Jimenez J, De-Castellar R, Catena A, Garcia-Santos JA, Bermudez MG, Campoy C. Association study between hypothalamic functional connectivity, early nutrition, and glucose levels in healthy children aged 6 years: The COGNIS study follow-up. Front Nutr. 2022 Oct 12;9:935740. doi: 10.3389/fnut.2022.935740. eCollection 2022.
- Derived from this study: PubMed 35777109Cerdo T, Ruiz A, Acuna I, Nieto-Ruiz A, Dieguez E, Sepulveda-Valbuena N, Escudero-Marin M, Garcia-Santos JA, Garcia-Ricobaraza M, Herrmann F, Moreno-Munoz JA, De Castellar R, Jimenez J, Suarez A, Campoy C. A synbiotics, long chain polyunsaturated fatty acids, and milk fat globule membranes supplemented formula modulates microbiota maturation and neurodevelopment. Clin Nutr. 2022 Aug;41(8):1697-1711. doi: 10.1016/j.clnu.2022.05.013. Epub 2022 May 23.
- Derived from this study: PubMed 35356726Nieto-Ruiz A, Garcia-Santos JA, Verdejo-Roman J, Dieguez E, Sepulveda-Valbuena N, Herrmann F, Cerdo T, De-Castellar R, Jimenez J, Bermudez MG, Perez-Garcia M, Miranda MT, Lopez-Sabater MC, Catena A, Campoy C. Infant Formula Supplemented With Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids, and Synbiotics Is Associated With Neurocognitive Function and Brain Structure of Healthy Children Aged 6 Years: The COGNIS Study. Front Nutr. 2022 Mar 9;9:820224. doi: 10.3389/fnut.2022.820224. eCollection 2022.
- Derived from this study: PubMed 33602357Sepulveda-Valbuena N, Nieto-Ruiz A, Dieguez E, Herrmann F, Escudero-Marin M, De-Castellar R, Rodriguez-Palmero M, Miranda MT, Garcia-Santos JA, Bermudez MG, Campoy C. Growth patterns and breast milk/infant formula energetic efficiency in healthy infants up to 18 months of life: the COGNIS study. Br J Nutr. 2021 Dec 28;126(12):1809-1822. doi: 10.1017/S000711452100057X. Epub 2021 Feb 19.
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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.
Cristina Campoy, Professor principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New infant formula, Standard infant formula and Breastfeeding in people with Infant Development, run by Laboratorios Ordesa at 1 site in Spain.
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 10 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: status not confirmed, as of the sponsor's last update on 12 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 Spain. 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?
Results are not available in the source record.
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?
Neurocognitive Development (time frame: At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months.). The study lists 3 primary outcomes in all. 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 NCT02094547, which also lists 4 linked publications.
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 12 Jul 2019.