Healthy InfantsNCT00325208
Feeding Bottle Design, Milk Intake and Infant Growth
A study testing partial-vacuum milk bottle and anti-vacuum milk bottle in people with Healthy Infants, run by Institute of Child Health at 3 sites in United Kingdom.
Trial summary
It is increasingly recognised that rapid growth in infancy may be associated with a greater risk of cardiovascular disease later in life. This trial will investigate whether the use of infant feeding bottles with different designs influences the milk intake and growth of infants. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- partial-vacuum milk bottle and anti-vacuum milk bottle
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Start not givento Dec 2006
- Phase
- Interventional
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy term infants birth weight >2.50kg, gestational age >37 weeks
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Mary Fewtrell contact
United Kingdom3 sites, 3 recruiting
- Recruiting
Hillingdon hospital
London
A Khakoo
- Recruiting
Northwick Park Hospital
London
R Nicholl
- Recruiting
The Institute of Child health
London
Mary Fewtrell, m.fewtrell@ich.ucl.ac.uk
About this study
It is increasingly recognised that rapid growth in infancy may be associated with a greater risk of cardiovascular disease later in life. This trial will investigate whether the use of infant feeding bottles with different designs influences the milk intake and growth of infants. We will compare the growth of bottle-fed infants with that of a breast-fed reference group.
- Conditions
- Healthy Infants
- Being tested
- partial-vacuum milk bottle, anti-vacuum milk bottle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial-vacuum milk bottleDevice
anti-vacuum milk bottleDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study completionDec 2006
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 Healthy InfantsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Mary Fewtrell, Principal investigator, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325208
- Sponsor's protocol ID
- 06NT01
- Status last verified
- Dec 2006
- First submitted
- 11 May 2006
- Last updated
- 25 Dec 2006
- Results posted
- No
Publications
Fewtrell MS, Kennedy K, Nicholl R, Khakoo A, Lucas A. Infant feeding bottle design, growth and behaviour: results from a randomised trial. BMC Res Notes. 2012 Mar 16;5:150. doi: 10.1186/1756-0500-5-150.
PubMed 22424116
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Bottle Design, Milk Intake and Infant Growth
- ClinicalTrials.gov ID
- NCT00325208
- Acronym / sponsor ID
- 06NT01
- Conditions
- Healthy Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study completion
- Dec 2006
- First posted
- 12 May 2006 (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.
It is increasingly recognised that rapid growth in infancy may be associated with a greater risk of cardiovascular disease later in life. This trial will investigate whether the use of infant feeding bottles with different designs influences the milk intake and growth of infants. We will compare the growth of bottle-fed infants with that of a breast-fed reference group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy term infants birth weight >2.50kg, gestational age >37 weeks
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| partial-vacuum milk bottle | Device | – |
| anti-vacuum milk bottle | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2006.
- Derived from this study: PubMed 22424116Fewtrell MS, Kennedy K, Nicholl R, Khakoo A, Lucas A. Infant feeding bottle design, growth and behaviour: results from a randomised trial. BMC Res Notes. 2012 Mar 16;5:150. doi: 10.1186/1756-0500-5-150.
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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.
Mary Fewtrell contact
Mary Fewtrell principal investigator
Institute of Child Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial-vacuum milk bottle and anti-vacuum milk bottle in people with Healthy Infants, run by Institute of Child Health at 3 sites in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Fewtrell (m.fewtrell@ich.ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325208, 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 25 Dec 2006.