NCT00325208

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 25, 2006

Status Verified

December 1, 2006

First QC Date

May 11, 2006

Last Update Submit

December 22, 2006

Conditions

Healthy Infants

Interventions

partial-vacuum milk bottleDEVICE
anti-vacuum milk bottleDEVICE

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hillingdon hospital

London, United Kingdom

RECRUITING

Northwick Park Hospital

London, United Kingdom

RECRUITING

The Institute of Child health

London, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22424116DERIVED

Study Officials

  • Mary Fewtrell

    Institute of Child Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Fewtrell

CONTACT

m.fewtrell@ich.ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Completion

December 1, 2006

Last Updated

December 25, 2006

Record last verified: 2006-12

Locations

GB(3)