The Preterm Infant Parenting Study
| ISRCTN | ISRCTN56341521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56341521 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/09/2005
- Registration date
- 08/09/2005
- Last edited
- 01/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andrew Whitelaw
Scientific
Scientific
Neonatal Medicine
University of Bristol Medical School
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0)117 959 5699 |
|---|---|
| andrew.whitelaw@bristol.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/2002 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Neonatal Medicine
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
University of Bristol (UK)
University/education
University/education
Gillian Tallents
Research and Development
University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| gillian.tallents@bristol.ac.uk | |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
The Health Foundation (UK) (ref: 265/1063)
No information available
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 | 01/11/2007 | Yes | No | |
| Results article | results | 01/10/2009 | Yes | No |
