Contact information
Type
Scientific
Primary contact
Prof Andrew Whitelaw
ORCID ID
Contact details
Neonatal Medicine
University of Bristol Medical School
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 959 5699
andrew.whitelaw@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PIPS
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Preterm birth
Intervention
The Parent Baby Interaction Programme versus no intervention
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Parental Stess Index at 3 months post term
2. Bayley Scales of Infant Development at 2 years post term
Secondary outcome measures
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
Overall trial start date
01/07/2002
Overall trial end date
30/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infants born before 32 weeks gestation, and their mothers
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Congenital abnormalities and chromosome disorders recognisable at birth.
2. Mothers unable to understand English.
Recruitment start date
01/07/2002
Recruitment end date
30/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Neonatal Medicine
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
Gillian Tallents
Research and Development
University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
gillian.tallents@bristol.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Health Foundation (UK) (ref: 265/1063)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17301114
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19595367
Publication citations
-
Results
Glazebrook C, Marlow N, Israel C, Croudace T, Johnson S, White IR, Whitelaw A, Randomised trial of a parenting intervention during neonatal intensive care., Arch. Dis. Child. Fetal Neonatal Ed., 2007, 92, 6, F438-43, doi: 10.1136/adc.2006.103135.
-
Results
Johnson S, Whitelaw A, Glazebrook C, Israel C, Turner R, White IR, Croudace T, Davenport F, Marlow N, Randomized trial of a parenting intervention for very preterm infants: outcome at 2 years., J. Pediatr., 2009, 155, 4, 488-494, doi: 10.1016/j.jpeds.2009.04.013.