Protein-Energy Malnutrition
Conditions
Interventions
The research is a randomized, double-blind, controlled and longitudinal clinical study. The study population will consist of healthy infants aged =14 days of age, artificially breastfed, who will be r
from the 6th month and up to 12 months of life, infants in the test and control groups will receive follow-up infant formula with 4.0 g/L of GOS/FOS, without 2´-FL. Randomization will be done in block
G07.203.300.456
Sponsors
Nestlé Brasil Ltda
Hospital e Maternidade São Luiz
Eligibility
Age
0 Days to 14 Days
Inclusion criteria
Inclusion criteria: Healthy infants; with 0 to 14 days old; born at term (gestational age between 37 and 42 weeks); who had a birth weight between 2500 and 4500g; exclusively breastfed or exclusively artificially breastfed
Exclusion criteria
Exclusion criteria: Infants on mixed breastfeeding; infants who start complementary feeding before 4 months of age; infants with congenital disease or malformation that may affect growth; severe prenatal or postnatal illness prior to inclusion; parents under 18 years old; parents not expected to comply with study procedures; and current or previous participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EXPECTED OUTCOME 1. The primary outcome will be weight gain (g/day) between inclusion and 4 months of life, considering a non-inferiority margin of -3 g/day and a standard deviation of 6.1 g/day.;FOUND OUTCOME 1. All infants after the intervention period were considered eutrophic, according to the nutritional status classification, with growth and development within normal limits for their age according to percentile parameters between 3 and 97 and Z-score between -2SD and +2SD. | — |
Secondary
| Measure | Time frame |
|---|---|
| EXPECTED OUTCOME 2. Secondary outcomes will be anthropometric measures (weight, length, BMI, head circumference); gastrointestinal tolerance; stool characteristics; fecal microbiota composition; behavior patterns (crying, irritability, sleep); adverse events reported by parents; and medication use;FOUND OUTCOME 2. Flatulence, excessive crying and longer irritability were more common in breast-fed infants, compared to the other two groups, both in the period immediately before the start of the intervention and in the final three days of the intervention. In the final period, the LM group also presented a greater number of regurgitations. The group that received HMO had similar rates of symptoms except for having shorter irritation time and more hours of sleep per night compared to the GOS/FOS group. The intestinal habits of infants in the three groups were similar at the beginning and end of the study in terms of frequency, evacuation effort and stool consistency. The addition of oligosaccharides (2'-FL, GOS and FOS) to infant formulas did not bring the alpha diversity of the intestinal microbiota of artificially breastfed infants closer to that of the breast milk reference. The beta-diversity of the three groups (HMO, GOS+FOS and LM) were different from each other at the end of the study. The addition of the HMO molecule (2'-FL) to an infant formula with the combination of prebiotics GOS+FOS, provided a greater relative abundance of the phylum Actinobacteriota and the genus Bifidobacterium at the end of the intervention, which was similar to the breast milk group ( p>0.05). From a clinical point of view, it was associated with less irritation time and more hours of sleep per night compared to the other groups. | — |
Countries
Brazil
Contacts
Public ContactElaine Mosquera
Nestlé Brasil Ltda
Outcome results
None listed