Study Towards the Effects of Post-discharge nutrition on growth and body composition of infants born less than or equal to 32 weeks gestation and/or less than or equal to 1500 g birth weight

ISRCTN ISRCTN53695702
DOI https://doi.org/10.1186/ISRCTN53695702
Secondary identifying numbers NTR55
Submission date
04/08/2005
Registration date
04/08/2005
Last edited
08/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr E.M. Amesz
Scientific

P.O. Box 7057, dep 9D11
Amsterdam
1007 MB
Netherlands

Phone +31 (0)20 444 2480
Email eline.amesz@vumc.nl

Study information

Study designRandomised single-blind active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleStudy Towards the Effects of Post-discharge nutrition on growth and body composition of infants born less than or equal to 32 weeks gestation and/or less than or equal to 1500 g birth weight
Study acronymSTEP
Study objectives1. To study the effects of post-dicharge nutrition on the growth, body composition, metabolism and neurodevelopment of premature infants
2. To study the effects of catch-up growth on the body composition, metabolism and neurodevelopment of premature infants
Ethics approval(s)Ethics approval received from the local ethics committee
Health condition(s) or problem(s) studiedPrematurity, growth retardation (intrauterine and/or postnatal)
InterventionRandomisation to post-discharge or term formula between 0 and 6 months corrected age. Breast milk group as a control group. All the formula and the breast milk with fortifier are prescribed in a volume of 175 ± 15 ml/kg/day (160 - 190 ml/kg/day).

The infants are seen at the outpatient clinic at 0, 3, 6, 12 and 24 months corrected age. Anthropometry is performed and motorneurodevelopment is tested by a physiotherapist. At 0, 3 and 6 months corrected age a fasting venous blood sample is taken and urine is collected. At 0 and 6 months corrected age the body composition is established with a dual-energy x-ray absorptiometry (DEXA) scan. Parents keep weekly dairies and telephonic support is offered on a regular basis.
Intervention typeOther
Primary outcome measureGrowth and body composition (bone density, fat percentage).
Secondary outcome measures1. Anaemia
2. Bone markers
3. Protein status
4. Metabolism (oleic acid [OA] glucose, cholesterol, insulin-like growth factor-I [IGF-I])
5. Free fatty acids in red blood cells
6. Neurodevelopment
Overall study start date01/08/2003
Completion date01/09/2009

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants150
Key inclusion criteria1. Gestational age less than or equal to 32 weeks with a birth weight less than or equal to 2000 g or a birth weight less than or equal to 1500 g and a gestational age less than or equal to 34 weeks
2. At least one parent or caretaker who speaks Dutch or English
Key exclusion criteriaConditions that influence the growth like:
1. Severe congenital anomalies
2. Bronchopulmonary dysplasia defined as an O2 requirement above 25% at 36 weeks gestation, any O2 requirement at 38 weeks gestation or any respiratory support at 40 weeks gestation
3. Severe intracerebral haemorrhage or ischaemia diagnosed before inclusion
4. Gastrointestinal surgery and gastrointestinal diseases known to influence growth
Date of first enrolment01/08/2003
Date of final enrolment01/09/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

P.O. Box 7057, dep 9D11
Amsterdam
1007 MB
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
University/education

Department of Paediatrics and Neonatology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Website http://www.vumc.nl
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Industry

Friesland Foods (The Netherlands) - Department of Research and Development

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2011 Yes No
Results article results 01/09/2012 Yes No
Results article results 01/08/2014 Yes No