Preterm infants knowledge on target height and outcome

ISRCTN	ISRCTN80622320
DOI	https://doi.org/10.1186/ISRCTN80622320
Protocol serial number	N/A
Sponsor	University Medical Center Groningen (UMCG) (The Netherlands)
Funders	Friesland Foods Units Western Europe and Enhanced Nutrition and Research (ENSU) (The Netherlands), Abbott (The Netherlands), Cornelia Foundation for the Mentally Handicapped Child (USA), Stichting Vrienden Beatrix Kinderziekenhuis, Anneke Bulk General Child Health Care Research Fund (The Netherlands)

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

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
Email	j.m.kerstjens@bkk.umcg.nl

Study information

Primary study design	Observational
Study design	Observational prospective cohort study
Secondary study design	Cohort study
Study type	Participant 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(s)	Neurodevelopment and growth
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.