NCT02094547

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

5.3 years

First QC Date

March 20, 2014

Last Update Submit

July 10, 2019

Conditions

Infant Development

Keywords

Infant FormulaCognitionNeurodevelopmentImmunityMicrobiota

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    At 4 and 6 years of age

  • Neurocognitive Development at 6 years

    Functional Magnetic Resonance Image

    At 6 years of age

Secondary Outcomes (8)

  • Formula Tolerability

    At 2nd, 3rd, 4th, 6th, 12th and 18th months.

  • Growth

    At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.

  • Incidence of infections

    At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.

  • Immunoglobulin A secretor (IgAs) levels

    At 3rd, 6th, 12th,18th month, and 4 years old.

  • Impact on microbiota

    At 3rd, 6th, 12th and 18th months; 4 and 6 years of age.

  • +3 more secondary outcomes

Other Outcomes (1)

  • Dietary assessment

    At 6th, 12th and 18th months; 2.5, 4 and 6 years.

Study Arms (3)

New infant formula

EXPERIMENTAL

New infant formula with key ingredients.

Dietary Supplement: New infant formula

Standard infant formula

ACTIVE COMPARATOR

Standard infant formula

Dietary Supplement: Standard infant formula

Breastfeeding

OTHER

Control

Dietary Supplement: Breastfeeding

Interventions

New infant formulaDIETARY_SUPPLEMENT

New infant formula

New infant formula
Standard infant formulaDIETARY_SUPPLEMENT

Standard infant formula

Standard infant formula
BreastfeedingDIETARY_SUPPLEMENT

Exclusive breastfeeding or less tan 25% formula intake

Breastfeeding

Eligibility Criteria

Age1 Day - 60 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full-term newborns (\>37 weeks and \<41 weeks gestation)
  • Adequate birth weight for his gestational age (between 3-97 percentiles)
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina

Granada, 18071, Spain

Location

Related Publications (4)

  • 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.

    PMID: 36313089DERIVED

  • 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.

    PMID: 35777109DERIVED

  • 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.

    PMID: 35356726DERIVED

  • 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.

    PMID: 33602357DERIVED

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Cristina Campoy, Professor

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 24, 2014

Study Start

December 1, 2010

Primary Completion

March 1, 2016

Study Completion

October 1, 2020

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations

ES(1)