HealthyNCT01370967
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 24 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 49 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Study formula feeding, Human milk feeding and Mixed feeding
- How many people
- 460 participants
- Where
- 24 sitesChina
- Study dates
- Jul 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 49 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy term infants aged approximately 42 days (range 35 - 49 days) who are brought to the health clinic for their first normally-scheduled well-baby visit (i.e. typically age 42 days in China).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Beijing Obstetrics Gynecology Hospital
Beijing
Peking University First Hospital
Beijing
Changsha Hospital for Maternal&Child Health Care
Changsha, Hunan
The 306th Hospital of PLA
Chaoyang District, Beijing Municipality
Chengdu Women & Children Center Hospital
Chengdu, Sichuan
West China Second University Hospital, SCU
Chengdu, Sichuan
Dongguan People's Hospital
Dongguan, Guangdong
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510150
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Zhu Jiang Hospital of Southern Medical University
Guangzhou, Guangdong
Beijing Haidian Maternal&Child Health Hospital
Haidian District, Beijing Municipality
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Maternity and Child Health Care Hospital in Jiangsu Province
Nanjing, Jiangsu
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu
Tianjin First Center Hospital
Nankai, Tianjin Municipality
Ningbo Yinzhou People's Hospital
Ningbo, Zhejiang
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200127
Children's Hospital of Fudan University
Shanghai
Shantou Central Hospital
Shantou, Guangdong
Suzhou Municipal Hospital
Suzhou, Jiangsu
Children's Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality
Zhongshan Bo'ai Hospital
Zhongshan, Guangdong
About this study
Official title: Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China
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.
Read the detailed description
Parents / legally acceptable representatives of eligible infants will be invited to volunteer.
- Conditions
- Healthy
- Being tested
- Study formula feeding, Human milk feeding, Mixed feeding
- Keywords
- infant, term birth, human milk, infant formula, breast feeding, bottle feeding, gastrointestinal tract, quality of life, infant development
- Medical subject headings
- Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study formula feedingOther
Infants who are exclusively fed the new study formula at time of enrollment
Human milk feedingOther
Infants who are exclusively fed human milk at time of enrollment
Mixed feedingOther
Infants who are exclusively fed human milk and the new study formula at time of enrollment
| Study group | Role | What they receive |
|---|---|---|
| Study formula-fed only | Not described Receives: Other: Study formula feeding | |
| Human milk-fed only | Not described Receives: Other: Human milk feeding | |
| Mixed-fed using study formula only | Not described Receives: Other: Mixed feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Measured: Baseline
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Measured: day 15
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Measured: day 30
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Measured: day 45
Secondary outcomes (5)
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Measured: Baseline
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Measured: day 18
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Measured: day 48
Infant and parent health-related quality of life (assessed using validated parent questionnaires)
Measured: Baseline
Infant and parent health-related quality of life (assessed using validated parent questionnaires)
Measured: day 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370967
- Sponsor's protocol ID
- B3611002
- Status last verified
- Dec 2013
- First submitted
- 8 Jun 2011
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hays NP, Mao M, Zhang L, Ge J, Northington R, Yao M, Volger S. Infant feeding and health-related quality of life in healthy Chinese infants: results from a prospective, observational cohort study. Health Qual Life Outcomes. 2016 Aug 8;14(1):116. doi: 10.1186/s12955-016-0518-3.
PubMed 27502768
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China
- ClinicalTrials.gov ID
- NCT01370967
- Acronym / sponsor ID
- B3611002
- Conditions
- Healthy
- Keywords
- infant, term birth, human milk, infant formula, breast feeding, bottle feeding, gastrointestinal tract, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Parents / legally acceptable representatives of eligible infants will be invited to volunteer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study formula-fed only | – | Other: Study formula feeding |
| Human milk-fed only | – | Other: Human milk feeding |
| Mixed-fed using study formula only | – | Other: Mixed feeding |
Who may qualify
- Ages
- 35 to 49 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy term infants aged approximately 42 days (range 35 - 49 days) who are brought to the health clinic for their first normally-scheduled well-baby visit (i.e. typically age 42 days in China).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study formula feedingInfants who are exclusively fed the new study formula at time of enrollment | Other | Study formula-fed only |
| Human milk feedingInfants who are exclusively fed human milk at time of enrollment | Other | Human milk-fed only |
| Mixed feedingInfants who are exclusively fed human milk and the new study formula at time of enrollment | Other | Mixed-fed using study formula only |
Primary outcome
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: Baseline
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: day 15
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: day 30
Infant stool consistency and frequency (assessed using a 3-day stool diary)
Time frame: day 45
5 secondary outcomes
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Time frame: Baseline
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Time frame: day 18
Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)
Time frame: day 48
Infant and parent health-related quality of life (assessed using validated parent questionnaires)
Time frame: Baseline
Infant and parent health-related quality of life (assessed using validated parent questionnaires)
Time frame: day 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Derived from this study: PubMed 27502768Hays NP, Mao M, Zhang L, Ge J, Northington R, Yao M, Volger S. Infant feeding and health-related quality of life in healthy Chinese infants: results from a prospective, observational cohort study. Health Qual Life Outcomes. 2016 Aug 8;14(1):116. doi: 10.1186/s12955-016-0518-3.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant stool consistency and frequency (assessed using a 3-day stool diary) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01370967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.