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

Infant Development Clinical Trial

— COGNIS  

Official title:

Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02094547
• Other study ID #: FC0G - 010
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2010
• Est. completion date: October 2020

Study information

• Verified date: July 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: October 2020
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development

Intervention

Dietary Supplement:
• New infant formula
New infant formula
• Standard infant formula
Standard infant formula
• Breastfeeding
Exclusive breastfeeding or less tan 25% formula intake

Locations

Country	Name	City	State
Spain	Facultad de Medicina	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Ordesa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary assessment	Food frequency questionnaires and 24 h food recalls.	At 6th, 12th and 18th months; 2.5, 4 and 6 years.
Primary	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.
Primary	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
Primary	Neurocognitive Development at 6 years	Functional Magnetic Resonance Image	At 6 years of age
Secondary	Formula Tolerability	Evaluation of gastrointestinal symptoms and sleep disorders amongst groups.	At 2nd, 3rd, 4th, 6th, 12th and 18th months.
Secondary	Growth	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.
Secondary	Incidence of infections	Number of infections reported.	At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
Secondary	Immunoglobulin A secretor (IgAs) levels	Inter and intragroup differences measured by saliva samples analysis.	At 3rd, 6th, 12th,18th month, and 4 years old.
Secondary	Impact on microbiota	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.
Secondary	Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels	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.
Secondary	Cardiovascular factors	Blood pressure measurement	At 4 and 6 years old
Secondary	Glucose monitoring	Urine metabolomic analysis	At 6 years old

External Links

•   Spanish Pediatric Association (AEP) Congress 2015 - Poster Book - P117 and P122