A Neurocognitive and Immunological Study of a New Formula for Healthy Infants
NCT ID: NCT02094547
Last Updated: 2019-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
220 participants
INTERVENTIONAL
2010-12-31
2020-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of a New Infant Formula With Specific Ingredients
NCT04306263
A Randomised, Controlled, Double-blinded, Multi-country, Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and Follow-on Formula for Healthy Term Infants.
NCT06475521
Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study
NCT05310396
Clinical Trial for Valuation of the Effectiveness of Lactoferrine in the Prevention of Sepsis in New Premature Born. Bimonitorization of the Antinflammatory Mechanisms, Antioxidants and the Intestinal Microbiote.
NCT03472170
Effect of a New Infant Cereal on Weight Gain
NCT02165956
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
New infant formula
New infant formula with key ingredients.
New infant formula
New infant formula
Standard infant formula
Standard infant formula
Standard infant formula
Standard infant formula
Breastfeeding
Control
Breastfeeding
Exclusive breastfeeding or less tan 25% formula intake
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
New infant formula
New infant formula
Standard infant formula
Standard infant formula
Breastfeeding
Exclusive breastfeeding or less tan 25% formula intake
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Normal Apgar score: 7-10
* Umbilical pH ≥ of 7.10
* Availability to continue during the whole study period
* Informed consent signed ( parent/legal representative)
Exclusion Criteria
* 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.
1 Day
60 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Laboratorios Ordesa
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cristina Campoy, Professor
Role: PRINCIPAL_INVESTIGATOR
Universidad de Granada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Facultad de Medicina
Granada, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Cerdo 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.
Nieto-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.
Sepulveda-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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FC0G - 010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.