Condition category
Neonatal Diseases
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
08/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes