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Preterm infants knowledge on target height and outcome
ISRCTN ISRCTN80622320
DOI 10.1186/ISRCTN80622320
ClinicalTrials.gov identifier
EudraCT number
Public title Preterm infants knowledge on target height and outcome
Scientific title
Acronym PINKELTJE
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Medical Ethical Review board of the University Medical Centre Groningen on the 2nd September 2005 (ref: 130-2005).
Study design Observational, prospective cohort study.
Countries of recruitment Netherlands
Disease/condition/study domain Low Birth Weight Infants
Participants - inclusion criteria All infants born before 36 completed weeks gestation in a well defined large region of the Netherlands in 2002 and 2003.
Participants - exclusion criteria 1. Major congenital malformations
2. Congenital infections
Anticipated start date 01/10/2005
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material
Target number of participants 2125
Interventions 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
Primary outcome measure(s) Neurodevelopment and growth.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding 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)
Trial website http://www.pinkeltje-onderzoek.nl
Publications 1. 2011 developmental delay 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
7. 2013 respiratory problems results in http://www.ncbi.nlm.nih.gov/pubmed/23525931
8. 2013 low socioeconomic status results in http://www.ncbi.nlm.nih.gov/pubmed/23968750
Contact name Dr  J M  Kerstjens
  Address University Medical Center Groningen
Department of Paediatrics
Division of Neonatology
Hanzeplein 1
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Tel +31 (0)50 361 4215
  Fax +31 (0)50 361 4235
  Email j.m.kerstjens@bkk.umcg.nl
Sponsor University Medical Center Groningen (UMCG) (The Netherlands)
  Address Beatrix Children's Hospital
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Sponsor website: http://www.rug.nl/umcg/index?lang=en
Date applied 28/12/2006
Last edited 09/01/2014
Date ISRCTN assigned 28/12/2006
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