Pilot study to compare preterm infant nutrition with individually supplemented with standard supplemented breast milk

ISRCTN	ISRCTN13923832
DOI	https://doi.org/10.1186/ISRCTN13923832
Secondary identifying numbers	18

Submission date: 29/01/2013
Registration date: 01/03/2018
Last edited: 08/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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?
Milupa (Germany)

Who is the main contact?
1. Prof. Dr. med. Ulrich H. Thome
ulrich.thome@medizin.uni-leipzig.de
2. Prof. Dr. Walter Mihatsch

Contact information

Prof Ulrich Thome
Scientific

Liebigstraße 20a
Leipzig
04103
Germany

Email	ulrich.thome@medizin.uni-leipzig.de

Study information

Study design	Randomized multi-center trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Pilot study to compare preterm infant nutrition with individually supplemented with standard supplemented breast milk
Study acronym	PPN
Study objectives	Supplementation of breast milk based on milk analysis results in better weight gain than standard supplementation.
Ethics approval(s)	Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 21/03/2013, ref: 082-13-11032013
Health condition(s) or problem(s) studied	Feeding preterm infants
Intervention	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.
Intervention type	Supplement
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 study start date	01/03/2013
Completion date	30/06/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	110
Key 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)
Key exclusion criteria	1. Abdominal surgery 2. Severe malformations
Date of first enrolment	21/06/2013
Date of final enrolment	31/08/2016

Locations

Countries of recruitment

Germany

Study participating centre

Children’s Hospital of the University of Leipzig

Department of Neonatalogy
Leipzig
04103
Germany

Sponsor information

University of Leipzig
University/education

Ritterstraße 26
Leipzig
04109
Germany

Email	oliver.gotthold@uni-leipzig.de
"ROR"	https://ror.org/03s7gtk40

Funders

Funder type

Industry

Milupa AG

No information available

Results and Publications

Intention to publish date	01/10/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal in October 2018.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

08/03/2018: Ethics approval details, publication and dissemination plan and IPD sharing statement added.