|
ISRCTN
|
ISRCTN75797522
|
|
DOI
|
10.1186/ISRCTN75797522
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
The impact of timing of surgical repair of cleft lip on parent-infant interactions and infant development
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
G9629970
|
|
Study hypothesis
|
To determine the effects of timing of lip repair on parent-infant relationship and infant development
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Plastic surgery
|
|
Participants - 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)
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/10/1997
|
|
Anticipated end date
|
30/09/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
200
|
|
Interventions
|
Groups are those having neonatal lip repair, and those having 'late' ie 2-3 month repair
|
|
Primary outcome measure(s)
|
Parental mental state, mother-infant interactions, infant social and cognitive development
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Medical Research Council (UK)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/15516162
|
|
Contact name
|
Professor
Lynne
Murray
|
|
Address
|
Winnicott Research Unit
Department of Psychology
University of Reading
3 Earley Gate
Whiteknights
|
|
City/town
|
Reading
|
|
Zip/Postcode
|
RG6 6AL
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
25/10/2000
|
|
Last edited
|
07/08/2008
|
|
Date ISRCTN assigned
|
25/10/2000
|
