Preterm infants knowledge on target height and outcome
| ISRCTN | ISRCTN80622320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80622320 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 15/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J M Kerstjens
Scientific
Scientific
University Medical Center Groningen
Department of Paediatrics
Division of Neonatology
Hanzeplein 1
PO Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 4215 |
|---|---|
| j.m.kerstjens@bkk.umcg.nl |
Study information
| Study design | Observational prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Preterm infants knowledge on target height and outcome |
| Study acronym | PINKELTJE |
| Study objectives | 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(s) | Medical Ethical Review board of the University Medical Centre Groningen, 02/09/2005, ref: 130-2005 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Neurodevelopment and growth |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/10/2005 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 2125 |
| Key inclusion criteria | All infants born before 36 completed weeks gestation in a well defined large region of the Netherlands in 2002 and 2003. |
| Key exclusion criteria | 1. Major congenital malformations 2. Congenital infections |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Beatrix Children's Hospital
PO Box 30001
Groningen
9700 RB
Netherlands
| Website | http://www.rug.nl/umcg/index?lang=en |
|---|---|
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Research organisation
Friesland Foods Units Western Europe and Enhanced Nutrition and Research (ENSU) (The Netherlands)
No information available
Abbott (The Netherlands)
No information available
Cornelia Foundation for the Mentally Handicapped Child (USA)
No information available
Stichting Vrienden Beatrix Kinderziekenhuis
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Research Foundation of the Beatrix Children’s Hospital, Stichting Beatrix Kinderziekenhuis
- Location
- Netherlands
Anneke Bulk General Child Health Care Research Fund (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | developmental delay results | 01/07/2011 | Yes | No | |
| Results article | behavioural and emotional problems results | 01/02/2012 | Yes | No | |
| Results article | demographics results | 01/08/2012 | Yes | No | |
| Results article | neonatal morbidity results | 01/08/2012 | Yes | No | |
| Results article | neuropsychological functioning results | 01/10/2012 | Yes | No | |
| Results article | developmental delay results | 01/12/2012 | Yes | No | |
| Results article | respiratory problems results | 01/06/2013 | Yes | No | |
| Results article | low socioeconomic status results | 01/11/2013 | Yes | No | |
| Results article | RSV infection results | 01/04/2015 | Yes | No | |
| Results article | gross motor milestones results | 01/04/2018 | Yes | No | |
| Results article | results | 01/12/2018 | Yes | No | |
| Results article | results | 02/05/2019 | 15/01/2020 | Yes | No |
| Results article | results | 17/02/2021 | 26/02/2021 | Yes | No |
| Results article | 17/03/2021 | 15/12/2021 | Yes | No |
Editorial Notes
15/12/2021: Publication reference added.
26/02/2021: Publication reference added.
15/01/2020: Publication reference added.
01/10/2018: Publication reference added.
27/03/2018: Publication reference added.
02/03/2016: Publication reference added.
