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Effect of Different Bottle Venting Methods on Infant Flatulence: A Multicenter Randomized Controlled Trial

Effect of Different Bottle Venting Methods on Infant Flatulence: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090082
Enrollment
Unknown
Registered
2024-09-24
Start date
2024-09-24
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild gastrointestinal discomfort of infants

Interventions

intervention group:Infants are to be fed using a bottom-vented bottle provided by the study.
control group:Infants are to be fed using a teat-vented bottle provided by the study.

Sponsors

Institute of Reproductive and Child Health, Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Months

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

MeasureTime frame
Incidence of mild gastrointestinal discomfort at the end of the 2nd week of intervention;

Secondary

MeasureTime 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

Public ContactLi Hongtian

Institute of Reproductive and Child Health, Peking University

lihongtian@pku.edu.cn+86 186 0000 3037

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 28, 2026