Condition category
Surgery
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
07/08/2008
Prospective/Retrospective
Retrospectively 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

Professor Lynne Murray

ORCID ID

Contact details

Winnicott Research Unit
Department of Psychology
University of Reading
3 Earley Gate
Whiteknights
Reading
RG6 6AL
United Kingdom

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/15516162

Publication citations

  1. 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.

Additional files

Editorial Notes