Condition category
Pregnancy and Childbirth
Date applied
01/09/2005
Date assigned
08/09/2005
Last edited
01/02/2013
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

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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes