Condition category
Oral Health
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
07/01/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Anthea Masarei

ORCID ID

Contact details

Speech and Language Therapy Department
Great Ormond Street Hospital for Children NHS Trust
Great Ormond Street
London
WC1N 3JH
United Kingdom
+44 (0)20 7813 8110
anthea.masarei@gosh-tr.nthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SP3308

Study information

Scientific title

Acronym

Study hypothesis

Added 08/01/2009:
To investigate the controversial assertion that pre-surgical orthopedics (PSO) facilitate feeding in infants with cleft lip and palate.

Ethics approval

Added 07/01/2010:
The Ethics Committee of GOSH and the Institute of Child Health gave approval.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Speech therapy

Intervention

Infants recruited are randomised to be managed with or without baby plates. Minimisation is used to ensure that groups are similar with respect to sex and birth order.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Added 08/01/2009:
Measurements were made at 3 months of age (pre-surgery) and at 12 months of age (post-surgery):
1. Anthropometry
2. Oral motor skills

Secondary outcome measures

Added 08/01/2009:
1. Objective measures of sucking, collected at 3 months using the Great Ormond Street Measure of Infant Feeding
2. Videofluoroscopic assessment (in 21 participants only)

Overall trial start date

01/01/2002

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born with an isolated cleft of the palate (soft palate and 2/3 of the hard palate) or complete unilateral cleft of the lip and palate and who are referred to the twin site cleft lip and palate centre of St Andrews Centre for Burns and Plastic Surgery and Great Ormond Street Hospital for Children NHS Trust

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Added 08/01/2009: 50

Participant exclusion criteria

Added 07/01/2010:
1. Required cardiac surgery
2. Diagnosed at birth with neurological impairment and/or a syndrome known to adversely affect feeding and/or growth

Recruitment start date

01/01/2002

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Speech and Language Therapy Department
London
WC1N 3JH
United Kingdom

Sponsor information

Organisation

Action Medical Research (UK)

Sponsor details

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Sponsor type

Charity

Website

http://www.action.org.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17328643

Publication citations

  1. Results

    Masarei AG, Wade A, Mars M, Sommerlad BC, Sell D, A randomized control trial investigating the effect of presurgical orthopedics on feeding in infants with cleft lip and/or palate., Cleft Palate Craniofac. J., 2007, 44, 2, 182-193, doi: 10.1597/05-184.1.

Additional files

Editorial Notes