Infant Behaviour

1

Review clinical trials related to Infant Behaviour. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years for the Improvement of Neurological Development

The main objective is to evaluate the effect of the Mediterranean diet during pregnancy and the first two years of the child\'s life on the child\'s neurodevelopment and behavior (externalizing and internalizing disorders) measured at one and a half and two years. Secondary objectives are to evaluate the effect of the Mediterranean diet on: body composition at two years of age in infants (densitometry) and of the mother at 3 months postpartum, the incidence of allergic disease in infants, the fetal and infant ́s growth and metabolic risk in the mother during pregnancy and in the boy/girl at two years (fasting glucose: insulin, HOMA), LDL and HDL cholesterol, and micronutrient status (iron, calcium, phosphorus, magnesium, sodium, potassium, chloride, selenium, zinc and LCPUFAs). Randomized controlled clinical trial with a 1:1 ratio, parallel and open label. Group 1: Mother-child binomial with nutritional intervention; Group 2: Mother-child binomial as a control group (with follow-up without intervention). Assuming a loss of 25% (10% at follow-up, 15% failure of nutritional intervention) we would need a sample size of 267 patients per group. 1. Evaluation of neurodevelopment using the Bayleys scale version -III, at 2 years of age. 2. Behavioral assessment CBCL at 1.5 and two years and BRIEF-P at two years.

Participants needed: 534
Trial details
Biological sex: AllType: InterventionalSponsor: Hospital Universitario La PazUpdated: Sep 26, 2024
Eligibility criteria

Children conceived with assisted reproduction techniques [+5]