Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9629970
Study information
Scientific title
Acronym
Study hypothesis
To determine the effects of timing of lip repair on parent-infant relationship and infant development
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Plastic surgery
Intervention
Groups are those having neonatal lip repair, and those having 'late' ie 2-3 month repair
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Parental mental state, mother-infant interactions, infant social and cognitive development
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1997
Overall trial end date
30/09/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Singleton infant, 37-42 week gestation, greater than 2.5 kg birthweight, index group have cleft lip (with or without cleft of palate)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1997
Recruitment end date
30/09/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Winnicott Research Unit
Reading
RG6 6AL
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Government
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/15516162
Publication citations
-
Results
Goodacre TE, Hentges F, Moss TL, Short V, Murray L, Does repairing a cleft lip neonatally have any effect on the longer-term attractiveness of the repair?, Cleft Palate Craniofac. J., 2004, 41, 6, 603-608, doi: 10.1597/03-028.1.