Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/01/2013
Date assigned
01/03/2018
Last edited
08/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulrich Thome

ORCID ID

Contact details

Liebigstraße 20a
Leipzig
04103
Germany
-
ulrich.thome@medizin.uni-leipzig.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18

Study information

Scientific title

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

Acronym

PPN

Study hypothesis

Supplementation of breast milk based on milk analysis results in better weight gain than standard supplementation.

Ethics approval

Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 21/03/2013, ref: 082-13-11032013

Study design

Randomized multi-center trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

01/03/2013

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

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)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Abdominal surgery
2. Severe malformations

Recruitment start date

21/06/2013

Recruitment end date

31/08/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Children’s Hospital of the University of Leipzig
Department of Neonatalogy
Leipzig
04103
Germany

Sponsor information

Organisation

University of Leipzig

Sponsor details

Ritterstraße 26
Leipzig
04109
Germany
-
oliver.gotthold@uni-leipzig.de

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Milupa AG

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/10/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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