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Municipal Transition and Intervention Program for Premature infants and their parents.
ISRCTN ISRCTN65503576
DOI 10.1186/ISRCTN65503576
ClinicalTrials.gov identifier
EudraCT number
Public title Municipal Transition and Intervention Program for Premature infants and their parents.
Scientific title
Acronym STIPP
Serial number at source 1
Study hypothesis The hypothesis is that infants who receive the Infant Behavioural Assessment and Intervention Program (IBAIP) will be able to regulate themselves better and that disabilities will therefore be prevented or develop to a less serious degree.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Multicentre, randomised, single blind, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Behavioural self-regulation and/or psychomotor problems
Participants - inclusion criteria 1. Gestation of less than 32 weeks and/or birth weight less than 1500 grams
2. Born in one of the Amsterdam hospitals
3. The infant's parents live in the Amsterdam area
Participants - exclusion criteria 1. Chromosome or syndrome disease
2. Children of addicted mothers (hard drugs or alcohol)
3. Parents unable to communicate in Dutch or English and who have no interpreter
4. Mothers with severe psychiatric illness
Anticipated start date 01/01/2004
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material
Target number of participants 180
Interventions For the intervention the IBA Intervention Program (IBAIP) will be used. The theoretical framework underlying the IBAIP is the "Synactive Model of Newborn Behavioural Organisation and Development".

The intervention aims at improving the developmental outcome of the child by assisting the parents as early as possible to support their child’s self regulation at a stage where changes are still reversible. The intervention method does not only support the child, but the parents as well, by offering them emotional, practical and individual support, so that excessive stress can be prevented.

By means of standardised IBA observations the child’s self regulating skills are examined.
All the child’s behavioural expressions and the inter-relationship are observed systematically and are interpreted by means of 4 systems:
1. The autonomic system
2. The motor system
3. The state system
4. The attention-interaction system

With the help of this neurological behaviour assessment one judges how a child can “play” with its various systems and is able to use them to achieve its goal. Consequently the measure of self-regulation determines the amount of support/intervention that should be offered.

The parental support consists of an increased awareness of their baby’s behavioural expressions and the interpretation of these expressions, so that the parents learn to intermediate between their child’s regulatory skills and the environment. The support they give may affect the environment (e.g. light, sounds, social interaction), functional positioning and ways of handling and the child’s specific self-regulatory strategies (e.g. sucking, holding something, seeking support).

As the child grows older it is to be expected that there will be an increase in the child’s self regulatory skills and consequently a decrease in the need for support/intervention. The family composition, the cultural diversity and the social/cultural safety network of the (often immigrant) parents will explicitly be taken into account during the project. After each home visit a report will be sent to the parents. This report will especially stress the competencies of the child and its parents. The interventions will be given by specially trained paediatric physical therapists that have the IBAIP certificate.
Primary outcome measure(s) 1. The Bayley Scales of Infant Development-II (BSID-II) at the corrected age of 24 months
2. The Still Face procedure at 6 months
3. The Working Model of Child Interview at 18 months
Secondary outcome measure(s) 1. The Infant Behavioural Assessment at 6 months
2. The BSID-II at 6 and 12 months
3. The Infant Toddler Symptom Checklist at 6, 12 and 24 months
4. The General Health Questionnaire at 6, 12 and 24 months
Sources of funding 1. The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
2. Reserve Voormalige Vrijwillige Ziekenfondsen (RVVZ) (Netherlands) - a governmental non-profit health organisation
Trial website
Publications 1. 2005 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/15707233
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19880139
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21784445
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21981307
5. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22406323
6. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23766396
Contact name Dr  M.J.  Wolf
  Address Department of Rehabilitation, A01
Academic Medical Center
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
Sponsor Academic Medical Centre (AMC) (Netherlands)
  Address Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 20/12/2005
Last edited 23/01/2014
Date ISRCTN assigned 20/12/2005
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