mild gastrointestinal discomfort of infants
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) the infant should be within 0 to 90 days of birth; (2) the infant should be bottle-fed at least 3 times daily or as often as expected. (either formula or breast milk); (3) the infant's mother should provide informed consent
Exclusion criteria
Exclusion criteria: (1) Infants who currently use or have previously used a bottom-vented bottle; (2) Infants who have difficulty in sucking or swallowing; (3) Infants who have been diagnosed with lactose intolerance or other conditions affecting gastrointestinal function; (4) Other conditions deemed unsuitable for participation in the study by a physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of mild gastrointestinal discomfort at the end of the 2nd week of intervention; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of mild gastrointestinal discomfort at the end of the 1st week of intervention;Total IGSQ score and scores for each dimension;Incidence of clinically significant gastrointestinal discomfort;Incidence of colic;Change in infant weight;Maternal postpartum anxiety score and incidence;Maternal postpartum depression score and incidence; | — |
Countries
China
Contacts
Institute of Reproductive and Child Health, Peking University