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ISRCTN
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ISRCTN80622320
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DOI
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10.1186/ISRCTN80622320
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Preterm infants knowledge on target height and outcome
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Scientific title
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Acronym
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PINKELTJE
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Serial number at source
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N/A
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Study hypothesis
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Growth and development of high risk and low risk preterm infants differ from children born at a normal gestational age. Perinatal risk factors, development and growth of high risk and low risk preterm infants are different.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval received from the Medical Ethical Review board of the University Medical Centre Groningen on the 2nd September 2005 (ref: 130-2005).
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Study design
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Observational, prospective cohort study.
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Low Birth Weight Infants
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Participants - inclusion criteria
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All infants born before 36 completed weeks gestation in a well defined large region of the Netherlands in 2002 and 2003.
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Participants - exclusion criteria
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1. Major congenital malformations
2. Congenital infections
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Anticipated start date
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01/10/2005
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2125
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Interventions
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In this observational, cohort study, there are no interventions; the following measurements will be made:
1. Measurement of growth parameters at the age of three years and nine months
2. Retrospective analysis medical records mother and child
3. Questionnaires on development , behaviour socio-economic and medical conditions at three years and nine months and at the age of five years
4. Wechsler Intelligence Scale for Children-Revised (WISC-R) intelligence test and movement Assessment Battery for Children (ABC) test between the age of six and seven years
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Primary outcome measure(s)
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Neurodevelopment and growth.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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1. Friesland Foods Units Western Europe and Enhanced Nutrition and Research (ENSU) (The Netherlands)
3. Abbott (The Netherlands)
4. Cornelia Foundation for the Mentally Handicapped Child (USA)
5. Beatrix Children’s Hospital Groningen Research Fund (The Netherlands)
6. Anneke Bulk General Child Health Care Research Fund (The Netherlands)
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Trial website
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http://www.pinkeltje-onderzoek.nl
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21324481
2. 2012 behavioural and emotional problems results in http://www.ncbi.nlm.nih.gov/pubmed/22147746
3. 2012 neonatal morbidity results in http://www.ncbi.nlm.nih.gov/pubmed/22778308
4. 2012 demographics results in http://www.ncbi.nlm.nih.gov/pubmed/22630341
5. 2012 neuropsychological functioning results in http://www.ncbi.nlm.nih.gov/pubmed/22945414
6. 2012 developmental delay results in http://www.ncbi.nlm.nih.gov/pubmed/23020259
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Contact name
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Dr
J M
Kerstjens
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Address
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University Medical Center Groningen
Department of Paediatrics
Division of Neonatology
Hanzeplein 1
P.O. Box 30001
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City/town
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Groningen
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Zip/Postcode
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9700 RB
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Country
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Netherlands
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Tel
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+31 (0)50 361 4215
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Fax
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+31 (0)50 361 4235
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Email
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j.m.kerstjens@bkk.umcg.nl
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Sponsor
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University Medical Center Groningen (UMCG) (The Netherlands)
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Address
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Beatrix Children's Hospital
P.O. Box 30001
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City/town
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Groningen
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Zip/Postcode
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9700 RB
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Country
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Netherlands
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Sponsor website:
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http://www.rug.nl/umcg/index?lang=en
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Date applied
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28/12/2006
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Last edited
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12/02/2013
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Date ISRCTN assigned
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28/12/2006
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