Contact information
Type
Scientific
Primary contact
Dr E.M. Amesz
ORCID ID
Contact details
P.O. Box 7057
dep 9D11
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2480
eline.amesz@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR55
Study information
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
Acronym
STEP
Study hypothesis
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
Ethics approval received from the local ethics committee
Study design
Randomised single-blind active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Growth and body composition (bone density, fat percentage).
Secondary outcome measures
1. 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 trial start date
01/08/2003
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/08/2003
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 7057, dep 9D11
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Paediatrics and Neonatology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Friesland Foods (The Netherlands) - Department of Research and Development
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
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21995887
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22750451
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24292818
Publication citations
-
Results
van de Lagemaat M, Rotteveel J, Muskiet FA, Schaafsma A, Lafeber HN, Post term dietary-induced changes in DHA and AA status relate to gains in weight, length, and head circumference in preterm infants., Prostaglandins Leukot. Essent. Fatty Acids, 2011, 85, 6, 311-316, doi: 10.1016/j.plefa.2011.09.005.
-
Results
van de Lagemaat M, Rotteveel J, van Weissenbruch MM, Lafeber HN, Small-for-gestational-age preterm-born infants already have lower bone mass during early infancy., Bone, 2012, 51, 3, 441-446, doi: 10.1016/j.bone.2012.06.017.
-
Results
van de Lagemaat M, Amesz EM, Schaafsma A, Lafeber HN, Iron deficiency and anemia in iron-fortified formula and human milk-fed preterm infants until 6 months post-term, Eur J Nutr, 2014, 53, 5, 1263-1271, doi: 10.1007/s00394-013-0629-0.