Infant nutrition
Conditions
Interventions
A2 group:Feeding by formula without A1ß-casein
Formula group:feeding with Aptamil formula
Breastfeeding group:Mainly breastfeeding
Sponsors
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects included in this study must meet all of the following criteria: 1. 0–76 days of age, inclusive (day of birth is considered day 0); 2. Single tire; 3. Gestational age is 37 – 42 weeks (36 weeks and 6 days is 36 weeks); 4. Birth weight 2500 g to 4500 G; 5. Sign the informed consent form for infants to participate in the study; 6. The parents or guardians of the infant agree not to allow the infant to participate in other intervention clinical studies during the study period; 7. Parents or guardians agree to feed infants according to a randomly assigned formula. In addition to the criteria listed above, subjects in a2 group or formula group must meet the following criteria: Parents or guardians agreed that infants should start on the standard formula as soon as they were enrolled and then switch to the randomly assigned formula at baseline (90 to 105 days) In addition to the criteria listed above, subjects in the breastfeeding group must meet the following criteria: Parents or guardians agree to breastfeed infants.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following criteria must be excluded: 1. Infants with congenital malformations and hereditary and / or chronic and / or congenital diseases that may interfere with the study, such as inability to breastfeed or formula fed; 2. Diseases endangering intrauterine growth; 3. Known or increased risk of IgE mediated cow's milk protein allergy (e.g. biological parents and / or siblings diagnosed with allergy, asthma, hay fever, etc.); 4. Infants with acute infection or gastroenteritis.? 5. Participate in other clinical trials 6. The researchers can not determine whether the parents were willing or able to comply with the protocol requirements (including filling in a diary until the infant was 4 months oldto start feeding complementary foods , and whether they were able and willing to collect, process and store faeces as instructed) 7. Immunocompromised infants (based on a doctor's diagnosis of immunodeficiency, such as combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and HIV infection-related secondary immunodeficiency, Down syndrome, etc.) and children with known head/brain diseases/injuries,Such as microcephaly, megacephaly, etc 8. Feeding difficulties or formula intolerance, such as vomiting or insufficient intake, were present at randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crying; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal SCFA, MPO, CRP, lactic acid and intestinal flora;Salivary inflammatory indicators; | — |
Countries
China
Contacts
Public ContactJiangqin Liu
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Outcome results
None listed