Overview

This trial is active, not recruiting.

Condition infant development
Treatments new infant formula, standard infant formula
Sponsor Laboratorios Ordesa
Start date December 2010
End date March 2017
Trial size 170 participants
Trial identifier NCT02094547, FC0G - 010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Experimental)
New infant formula with key ingredients.
new infant formula
New infant formula
(Active Comparator)
Standard infant formula
standard infant formula
Standard infant formula

Primary Outcomes

Measure
Neurocognitive Development
time frame: At 2nd, 3rd, 4th, 6th, 12th,18th, 24th, 36th months.

Secondary Outcomes

Measure
Tolerability
time frame: At 2nd, 3rd, 4th, 6th, 12th and 18th months.
Growth
time frame: At 2nd, 3rd, 4th, 6th, 12th,18th, 24th, 36th months.
Incidence of infections
time frame: At 2nd, 3rd, 4th, 6th, 12th,18th, 24th, 36th months.
Immunoglobulin A secretor (IgAs) levels
time frame: At 3rd, 6th, 12th,18th, 24th, 36th months.
Impact on microbiota
time frame: At 3rd, 6th, 12th and 18th months
Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels
time frame: At 3rd, 6th, 12th,18th, 24th, 36th months.

Eligibility Criteria

Male or female participants up to 60 days old.

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) - Maximum 30 days of exclusive breastfeeding - From 30 days on, exclusive or >70% infant formula - 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 currently participating in another clinical study - Infant's family who in the investigators assessment cannot be expected to comply with the protocol.

Additional Information

Official title Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes
Principal investigator Cristina Campoy, Professor
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Laboratorios Ordesa.