A Neurocognitive and Immunological Study of a New Formula for Healthy Infants (COGNIS)

July 10, 2019 updated by: Laboratorios Ordesa

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Facultad de Medicina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard infant formula
Dietary supplement: Standard infant formula
Standard infant formula
Experimental: New infant formula
New infant formula with key ingredients.
Dietary supplement: New infant formula
New infant formula
Other: Breastfeeding
Control
Dietary supplement: Breastfeeding
Exclusive breastfeeding or less tan 25% formula intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months.
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).
At 4 and 6 years of age
Neurocognitive Development at 6 years
Time Frame: At 6 years of age
Functional Magnetic Resonance Image
At 6 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Formula Tolerability
Time Frame: At 2nd, 3rd, 4th, 6th, 12th and 18th months.
Evaluation of gastrointestinal symptoms and sleep disorders amongst groups.
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.
Differences in growth parameters (weight, length, BMI, skin folds, perimeters and z-scores) between groups.
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.
Number of infections reported.
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.
Inter and intragroup differences measured by saliva samples analysis.
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.
Changes in microbiota composition measured by real-time polymerase chain reaction (RT-PCR) in faeces.
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.
Differences in LC-PUFAS levels inter and intragroup evaluated by oral mucosa samples analysis.
At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.
Cardiovascular factors
Time Frame: At 4 and 6 years old
Blood pressure measurement
At 4 and 6 years old
Glucose monitoring
Time Frame: At 6 years old
Urine metabolomic analysis
At 6 years old

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary assessment
Time Frame: At 6th, 12th and 18th months; 2.5, 4 and 6 years.
Food frequency questionnaires and 24 h food recalls.
At 6th, 12th and 18th months; 2.5, 4 and 6 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Ordesa

Investigators

  • Principal Investigator: Cristina Campoy, Professor, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 10, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FC0G - 010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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