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

Not Applicable

• Conditions: Infant Development
• Interventions: Dietary Supplement: New infant formula; Dietary Supplement: Standard infant formula; Dietary Supplement: Breastfeeding

• Registration Number: NCT02094547
• Lead Sponsor: Laboratorios Ordesa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-24
• Primary Completion: 2016-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New infant formula	New infant formula	New infant formula with key ingredients.
Standard infant formula	Standard infant formula	Standard infant formula
Breastfeeding	Breastfeeding	Control

Primary Outcome Measures

Name	Time	Method
Neurocognitive Development	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).
Neurocognitive Development at 4 and 6 years	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).
Neurocognitive Development at 6 years	At 6 years of age	Functional Magnetic Resonance Image

Secondary Outcome Measures

Name	Time	Method
Formula Tolerability	At 2nd, 3rd, 4th, 6th, 12th and 18th months.	Evaluation of gastrointestinal symptoms and sleep disorders amongst groups.
Growth	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.
Incidence of infections	At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.	Number of infections reported.
Immunoglobulin A secretor (IgAs) levels	At 3rd, 6th, 12th,18th month, and 4 years old.	Inter and intragroup differences measured by saliva samples analysis.
Impact on microbiota	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.
Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels	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.
Cardiovascular factors	At 4 and 6 years old	Blood pressure measurement
Glucose monitoring	At 6 years old	Urine metabolomic analysis

Trial Locations

Locations (1)

Facultad de Medicina; 🇪🇸 Granada, Spain