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

Laboratorios Ordesa

Status: Unknown

Conditions: Infant Development

Treatments: Dietary Supplement: Breastfeeding; Dietary Supplement: Standard infant formula; Dietary Supplement: New infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094547

FC0G - 010

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 1 to 60 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 3 patient groups

New infant formula

Experimental group

Description:

New infant formula with key ingredients.

Treatment:

Dietary Supplement: New infant formula

Standard infant formula

Active Comparator group

Description:

Standard infant formula

Treatment:

Dietary Supplement: Standard infant formula

Breastfeeding

Other group

Description:

Control

Treatment:

Dietary Supplement: Breastfeeding