Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/01/2015
Date assigned
11/02/2015
Last edited
04/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Human milk is the ideal food for all human babies and has a nutrient composition ideal for babies that have been born at full term. However, the protein and mineral content of human milk may not be sufficient for premature babies as they need more protein, sugars and fats for growth and development. Lack of nutrition of premature babies can lead to slower than usual growth and there are concerns regarding both the short and long-term neurodevelopment (brain and central nervous system development) of these babies. In this study, we are going to observe very premature babies, fed with their mother’s milk with blind macro nutrient content, fortified with standard human milk fortifier and protein supplementation according to ESPGHAN recommendations. We expect to find variation in the content of these nutrients and to see if that has some influence in body composition measured by somatometry and air plethismography as well as in neurodevelopment at 12 and 18 months of age.

Who can participate?
Premature babies of less than 34 weeks gestational age.

What does the study involve?
Immediately after discharge from hospital, the body composition of the babies included in the study is measured by plethismography, generally in the same day of other standard study. They all receive standard neonatal and after discharge care. At 12 months and again at 18 months, the neurodevelopment of all babies are assessed.

What are the possible benefits and risks of participating?
The study may give some insight in the need of macro-nutrient evaluation of feeding premature babies and may result in adjusting the nutrient content of supplements given. There are no expected risks, as it is an observational study and the follow up is the same for all the babies.

Where is the study run from?
Lisbon Central Hospital Centre (Portugal)

When is the study starting and how long is it expected to run for?
February 2014 to December 2014

Who is funding the study?
Milupa Portugal, Lda (Portugal)

Who is the main contact?
Dr Israel Macedo

Trial website

Contact information

Type

Public

Primary contact

Dr Israel Macedo

ORCID ID

Contact details

Alam Qta Sto Antonio 5-N3-2Esq
Lisbon
1600-675
Portugal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Effect of different composition of human milk and its fortification in body composition and neurodevelopment in a cohort of very preterm infants: a observational cohort study

Acronym

Study hypothesis

Preterm infants feed in the first weeks of life with recommended but different amounts of protein have different body composition (measured as % of FFM/FM) at 40 weeks gestational corrected age and different psychomotor development in the medium term.

Ethics approval

1. Hospital Board Ethics approval, 16/05/2012, ref: Nr 116/2012
2. A Comissão de Ética da NMS|FCM-UNL, 01/10/2015, ref: 75/2014/CEFCM

Study design

Prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (available in Portugese)

Condition

Body composition, BSDI II at 12 and 18 months

Intervention

1. Normal variation in human milk composition
2. Blind fortification plus protein supplementation - caregivers and evaluators blind to macronutrient composition.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Body composition by plethysmography at 40 weeks, Bayley Scales of Infant Development II (BSDI II) at 18 months

Secondary outcome measures

Neonatal morbidities

Overall trial start date

01/02/2014

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Preterms with less 34 weeks gestational age

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Congenital malformations
2. Formula feeding
3. Inability to achieve full enteral feeding
4. Parents inability to understand informed consent

Recruitment start date

01/02/2014

Recruitment end date

28/02/2015

Locations

Countries of recruitment

Portugal

Trial participating centre

Lisbon Central Hospital Centre (Centro Hospitalar Lisboa Central (MAC and HDE))
Rua Viriato 1069
Lisbon
1069
Portugal

Sponsor information

Organisation

Portuguese Neonatal Society

Sponsor details

c/o Rosalina Barroso
MD
Hospital Prof. Doutor Fernando Fonseca
Amadora
2720-276
Portugal

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Milupa Portugal, Lda

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. At least two publications
2. PhD thesis presentation

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/10/2016: The overall trial end date and recruitment end dates have been updated from 31/12/20174 to 28/02/2015. In addition, Milupa Portugal, Lda has been added as the funder and the participant information sheet has been uploaded. 24/03/2016: Ethics approval information added.