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Completed

NCT Number: NCT01370967

Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula

The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.

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Key information

Conditions

Healthy Behavior Bottle Feeding Breast Feeding Feeding Behavior

Age range

35 day–49 day

Sex eligibility

All sexes

Study type

Observational

Primary location

The 306th Hospital of PLA, Chaoyang District, Beijing Municipality, China

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About this study

Parents / legally acceptable representatives of eligible infants will be invited to volunteer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, term (37-42 weeks gestation), singleton infant at birth.
  • Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry.
  • At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts.

Exclusion criteria

  • Infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment.
  • Suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.

Treatment and study plan

Study formula feeding

Other

Infants who are exclusively fed the new study formula at time of enrollment

Human milk feeding

Other

Infants who are exclusively fed human milk at time of enrollment

Mixed feeding

Other

Infants who are exclusively fed human milk and the new study formula at time of enrollment

Primary outcomes

  1. Infant stool consistency and frequency (assessed using a 3-day stool diary)

    Time frame: Baseline

  2. Infant stool consistency and frequency (assessed using a 3-day stool diary)

    Time frame: day 15

  3. Infant stool consistency and frequency (assessed using a 3-day stool diary)

    Time frame: day 30

  4. Infant stool consistency and frequency (assessed using a 3-day stool diary)

    Time frame: day 45

Secondary outcomes

  1. Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)

    Time frame: Baseline

  2. Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)

    Time frame: day 18

  3. Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)

    Time frame: day 48

  4. Infant and parent health-related quality of life (assessed using validated parent questionnaires)

    Time frame: Baseline

  5. Infant and parent health-related quality of life (assessed using validated parent questionnaires)

    Time frame: day 48

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2011
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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