Feeding Bottle Design, Milk Intake and Infant Growth | NCT00325208

Studies
Feeding Bottle Design, Milk Intake and Infant Growth

NCT00325208

Sponsor

Institute of Child Health

Status

Unknown status

Last Update Posted

Dec 25, 2006Estimated

Enrollment

152

Phase

Not Applicable

Conditions

Healthy Infants

Interventions

partial-vacuum milk bottle
anti-vacuum milk bottle

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

May 11, 2006

First Submission Date that Met QC Criteria

May 11, 2006

First Posted Date

May 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2006

Last Update Posted Date

Dec 25, 2006Estimated

Description Module

Brief 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. We will compare the growth of bottle-fed infants with that of a breast-fed reference group.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

152

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy term infants birth weight >2.50kg, gestational age >37 weeks

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mary Fewtrell	Contact			m.fewtrell@ich.ucl.ac.uk

Overall Officials

Name	Affiliation	Role
Mary Fewtrell	Institute of Child Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillingdon hospital	Recruiting	London			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22424116	Derived	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.

Name	Type	Description	Arm Group Labels	Other Names
partial-vacuum milk bottle	Device
anti-vacuum milk bottle	Device