growth and development of children
Conditions
Interventions
Formula intervention group:Use the free 1-stage infant formula provided in this study, which complies with the new national standard "National Food Safety Standard for Infants Aged 0-6 Months - Infant
Formula control group:Family members of newborns can choose free of charge the first stage infant formula that meets the new national standard "National Food Safety Standard for Infant Formula Food" (
? Does not contain lactoferrin or has a content of = 50mg/100g
? No milk fat globule membrane
? No nucleotides or content = 20mg/100g, continuous feeding for 3 months ends.
Breastfeeding control group:The newborns in breastfeeding control group will be given pure breastfeeding after birth. If it is necessary to add or switch to artificial feeding due to medical reasons a
Sponsors
Chengdu Women’s & Children’s Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newborns born at 37-42 weeks of gestation, healthy, cesarean section, and whose parents voluntarily choose to be formula feed after birth, with a birth weight greater than or equal to 2500 and less than 4000g, without gender restrictions; 2. Newborns’ mothers have no metabolic diseases such as diagnosed diabetes, and no infectious diseases such as hepatitis B and HIV; 3. The parents or primary guardians of the newborn agree to collect peripheral blood samples for routine blood testing during the study period; 4. Parents agree to receive regular physical examinations in medical institutions and feeding advice and health guidance from child healthcare doctors; 5. Family members or primary guardians promise not to add probiotics for non disease treatment purposes to infants and young children during the intervention period (prescription probiotics for treatment purposes can be added according to the doctor's diagnosis and treatment requirements); 6. Parents of enrolled newborns agree to participate in this intervention study and sign a written informed consent form, and are able to understand and fill out forms such as infant diaries as required;
Exclusion criteria
Exclusion criteria: 1. Newborns with a history of asphyxia or NICU hospitalization at birth; 2. Newborns with birth defects or congenital abnormalities; 3. The mother of the newborn has pregnancy induced hypertension syndrome, eclampsia and pre-eclampsia, diabetes, cholestasis and other obstetric risk factors, as well as a history of alcoholism and drug abuse; 4. At the time of enrollment, the first-degree relative of the newborn was diagnosed with an allergic disease by a clinical physician (including but not limited to eczema, asthma, allergic proctitis, allergic rhinitis, hay fever, food allergies, etc.); 5. Newborns with severe primary diseases of other important organs or systems such as the heart, liver, kidneys, and hematopoietic system; 6. Prior to screening, having used experimental drugs since birth and participating in other clinical studies; 7. Researchers believe that there are other reasons why it is not appropriate to participate in the clinical trial, such as affecting efficacy evaluation or poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of allergy in infants;Intestinal health status of infants (occurrence of functional gastrointestinal diseases such as diarrhea and constipation and functional dyspepsia syndrome);Incidence of respiratory tract infections in infants and young children (including frequency, duration, intensity, and medication);infant development and growth; | — |
Countries
China
Contacts
Public ContactChen Ke
Chengdu Women’s & Children’s Central Hospital
Outcome results
None listed