Condition category
Pregnancy and Childbirth
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pinkeltje-onderzoek.nl

Contact information

Type

Scientific

Primary contact

Dr J M Kerstjens

ORCID ID

Contact details

University Medical Center Groningen
Department of Paediatrics
Division of Neonatology
Hanzeplein 1
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 4215
j.m.kerstjens@bkk.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Preterm infants knowledge on target height and outcome

Acronym

PINKELTJE

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.

Ethics approval

Medical Ethical Review board of the University Medical Centre Groningen, 02/09/2005, ref: 130-2005

Study design

Observational prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Low Birth Weight Infants

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Neurodevelopment and growth.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2005

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All infants born before 36 completed weeks gestation in a well defined large region of the Netherlands in 2002 and 2003.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2125

Participant exclusion criteria

1. Major congenital malformations
2. Congenital infections

Recruitment start date

01/10/2005

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

Beatrix Children's Hospital
P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.rug.nl/umcg/index?lang=en

Funders

Funder type

Research organisation

Funder name

Friesland Foods Units Western Europe and Enhanced Nutrition and Research (ENSU) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Abbott (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cornelia Foundation for the Mentally Handicapped Child (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Beatrix Children’s Hospital Groningen Research Fund (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anneke Bulk General Child Health Care Research Fund (The Netherlands)

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. 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
9. 2015 RSV infection results in: http://www.ncbi.nlm.nih.gov/pubmed/25189655

Publication citations

  1. Results

    Kerstjens JM, de Winter AF, Bocca-Tjeertes IF, ten Vergert EM, Reijneveld SA, Bos AF, Developmental delay in moderately preterm-born children at school entry., J. Pediatr., 2011, 159, 1, 92-98, doi: 10.1016/j.jpeds.2010.12.041.

  2. Results

    Potijk MR, de Winter AF, Bos AF, Kerstjens JM, Reijneveld SA, Higher rates of behavioural and emotional problems at preschool age in children born moderately preterm., Arch. Dis. Child., 2012, 97, 2, 112-117, doi: 10.1136/adc.2011.300131.

  3. Results

    Kerstjens JM, Bocca-Tjeertes IF, de Winter AF, Reijneveld SA, Bos AF, Neonatal morbidities and developmental delay in moderately preterm-born children., Pediatrics, 2012, 130, 2, e265-72, doi: 10.1542/peds.2012-0079.

  4. Results

    Cserjesi R, VAN Braeckel KN, Timmerman M, Butcher PR, Kerstjens JM, Reijneveld SA, Bouma A, Bos AF, Geuze RH, Patterns of functioning and predictive factors in children born moderately preterm or at term., Dev Med Child Neurol, 2012, 54, 8, 710-715, doi: 10.1111/j.1469-8749.2012.04328.x.

  5. Results

    Cserjesi R, Van Braeckel KN, Butcher PR, Kerstjens JM, Reijneveld SA, Bouma A, Geuze RH, Bos AF, Functioning of 7-year-old children born at 32 to 35 weeks' gestational age., Pediatrics, 2012, 130, 4, e838-46, doi: 10.1542/peds.2011-2079.

  6. Results

    Kerstjens JM, de Winter AF, Bocca-Tjeertes IF, Bos AF, Reijneveld SA, Risk of developmental delay increases exponentially as gestational age of preterm infants decreases: a cohort study at age 4 years., Dev Med Child Neurol, 2012, 54, 12, 1096-1101, doi: 10.1111/j.1469-8749.2012.04423.x.

  7. Results

    Vrijlandt EJ, Kerstjens JM, Duiverman EJ, Bos AF, Reijneveld SA, Moderately preterm children have more respiratory problems during their first 5 years of life than children born full term., Am. J. Respir. Crit. Care Med., 2013, 187, 11, 1234-1240, doi: 10.1164/rccm.201211-2070OC.

  8. Results

    Potijk MR, Kerstjens JM, Bos AF, Reijneveld SA, de Winter AF, Developmental delay in moderately preterm-born children with low socioeconomic status: risks multiply., J. Pediatr., 2013, 163, 5, 1289-1295, doi: 10.1016/j.jpeds.2013.07.001.

  9. Results

    Gijtenbeek RG1, Kerstjens JM, Reijneveld SA, Duiverman EJ, Bos AF, Vrijlandt EJ, RSV infection among children born moderately preterm in a community-based cohort, Eur J Pediatr, 2015 , 174, 4, 435-442, doi: 10.1007/s00431-014-2415-2.

Additional files

Editorial Notes

02/03/2016: Publication reference added.