The Preterm Infant Parenting Study

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Andrew Whitelaw
Scientific

Neonatal Medicine
University of Bristol Medical School
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Phone	+44 (0)117 959 5699
Email	andrew.whitelaw@bristol.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PIPS
Study objectives	Does the Parent-Baby Interaction Program introduced soon after premature birth reduce stress and depression in the mother and developmental delay at 2 years in the infant?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Preterm birth
Intervention	The Parent Baby Interaction Programme versus no intervention
Intervention type	Other
Primary outcome measure(s)	1. Parental Stess Index at 3 months post term 2. Bayley Scales of Infant Development at 2 years post term
Key secondary outcome measure(s)	1. Edinburgh Postnatal Depression Scale at 3 months post term 2. Home observation for measurement of the environment at 3 months post term 3. Neurobehavioural Assessment Premature Inventory (NAPI) at 35 weeks postmenstrual age 4. Nursing Child Teaching Scale at discharge from hospital 5. Postmenstrual age at discharge 6. Infant weight gain to discharge
Completion date	30/06/2005

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	250
Key inclusion criteria	Infants born before 32 weeks gestation, and their mothers
Key exclusion criteria	1. Congenital abnormalities and chromosome disorders recognisable at birth. 2. Mothers unable to understand English.
Date of first enrolment	01/07/2002
Date of final enrolment	30/06/2005

Neonatal Medicine

Bristol
BS10 5NB
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	01/11/2007		Yes	No
Results article	results	01/10/2009		Yes	No