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 |
| Protocol serial number | NTR55 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | Friesland Foods (The Netherlands) - Department of Research and Development |
- 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
Scientific
P.O. Box 7057, dep 9D11
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2480 |
|---|---|
| eline.amesz@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blind active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study acronym | STEP |
| Study objectives | 1. 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) studied | Prematurity, growth retardation (intrauterine and/or postnatal) |
| Intervention | Randomisation 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 type | Other |
| Primary outcome measure(s) |
Growth and body composition (bone density, fat percentage). |
| Key secondary outcome measure(s) |
1. Anaemia |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. 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 criteria | Conditions 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 enrolment | 01/08/2003 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 7057, dep 9D11
Amsterdam
1007 MB
Netherlands
1007 MB
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 |
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 |
