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
Protocol serial number	G9629970
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Lynne Murray
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Parental mental state, mother-infant interactions, infant social and cognitive development
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2000

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	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

Winnicott Research Unit

Reading
RG6 6AL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/11/2004		Yes	No