The impact of timing of surgical repair of cleft lip on parent-infant interactions and infant development
| ISRCTN | ISRCTN75797522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75797522 |
| Secondary identifying numbers | G9629970 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 07/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Professor Lynne Murray
Scientific
Scientific
Winnicott Research Unit
Department of Psychology
University of Reading
3 Earley Gate
Whiteknights
Reading
RG6 6AL
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To determine the effects of timing of lip repair on parent-infant relationship and infant development |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Plastic surgery |
| Intervention | Groups are those having neonatal lip repair, and those having 'late' ie 2-3 month repair |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Parental mental state, mother-infant interactions, infant social and cognitive development |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/1997 |
| Completion date | 30/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 200 |
| Key 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) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1997 |
| Date of final enrolment | 30/09/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Winnicott Research Unit
Reading
RG6 6AL
United Kingdom
RG6 6AL
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Government
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/11/2004 | Yes | No |
