Plain English Summary
Background and study aims
Gastrointestinal (digestive system) complications are reduced in preterm infants if they are fed with breast milk. However, breast milk must be fortified because the nutrient content is not enough for rapidly growing preterm infants. Furthermore, the nutrient content of breast milk can vary. The aim of this study is find out whether supplementation using measurements of actual nutrient content is better than standard supplementation.
Who can participate?
Preterm infants (gestational age 24 - 32 weeks) with a birth weight of 400 - 1499 g, receiving enteral (tube) feeds for at least 2 – 4 days
What does the study involve?
Infants are randomly allocate to receive either breast milk feeds supplemented with fortifiers calculated according to measured natural nutrient content, to provide nutrients according to the ESPGHAN recommendations, or breast milk supplemented with the standard amounts of fortifiers. Weight gain, bone growth, adipose (fat) tissue and blood amino acids are all measured over 8 weeks.
What are the possible benefits and risks of participating?
All infants receive extensive nutritional observation and evaluation. Infants on individualized supplementation may have faster weight gain because the varying nutrient contents of breast milk batches are compensated for. Breast milk fortification is standard in the care of preterm infants. Therefore, there are no additional risks from participation in this study.
Where is the study run from?
The Children’s Hospital of the University of Leipzig and the City Hospital Harlaching (Germany)
When is the study starting and how long is it expected to run for?
March 2013 to June 2014
Who is funding the study?
Who is the main contact?
1. Prof. Dr. med. Ulrich H. Thome
2. Prof. Dr. Walter Mihatsch
Prof Ulrich Thome
Pilot study to compare preterm infant nutrition with individually supplemented with standard supplemented breast milk
Supplementation of breast milk based on milk analysis results in better weight gain than standard supplementation.
Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 21/03/2013, ref: 082-13-11032013
Randomized multi-center trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Feeding preterm infants
Infants are randomized to receive either breast milk feeds supplemented with fortifiers calculated according to measured natural nutrient content, to provide nutrients according to the ESPGHAN recommendations, or breast milk supplemented with standard amounts of fortifiers.
Primary outcome measure
Weight gain measured daily
Secondary outcome measures
1. Linear growth: 2-weekly measurement (week 0, 2, 4, 6, 8)
2. Head circumference: 2-weekly measurement (week 0, 2, 4, 6, 8)
3. Leg growth: 2-weekly measurement (week 0, 2, 4, 6, 8)
4. Skin fold thickness: 2-weekly measurement (week 0, 2, 4, 6, 8)
5. Body composition at 36 (35 5/7 36 6/7) weeks corrected age
5.1. Analysis of body composition by air displacement, using the Pea Pod (CosmedR) (Munich center)
5.2. Analysis of body composition by bioimpedance analysis (Leipzig center).
6. Serum amino acid profile: measured at weeks 2, 4, 7
7. Bronchopulmonary dysplasia according to the HICHD consensus definition
8. Neurodevelopmental follow-up according to Bayley- 2 scales of infant development at 18-24 months corrected age
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Preterm infants < 1500 g birthweight receiving at least 100 ml/kg enteral feeds
2. Male and female premature infants with a gestational age of 24 - 32 weeks (24 0/7 - 31 6/7)
Target number of participants
Participant exclusion criteria
1. Abdominal surgery
2. Severe malformations
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Children’s Hospital of the University of Leipzig
Department of Neonatalogy
University of Leipzig
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal in October 2018.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)