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
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
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.
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
Prospective observational cohort study
Primary study design
Secondary study design
Patient information sheet
See additional files (available in Portuguese)
Body composition, BSDI II at 12 and 18 months
1. Normal variation in human milk composition
2. Blind fortification plus protein supplementation - caregivers and evaluators blind to macronutrient composition.
Primary outcome measure
1. Body composition by plethysmography at 40 weeks
2. Bayley Scales of Infant Development II (BSDI II) at 18 months
Secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Preterms with less 34 weeks gestational age
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
Lisbon Central Hospital Centre (Centro Hospitalar Lisboa Central (MAC and HDE))
Rua Viriato 1069
Milupa Portugal, Lda
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. At least two publications
2. PhD thesis presentation
Results published in 2017 thesis https://run.unl.pt/bitstream/10362/35458/1/Macedo%20Israel%20TD%202018.pdf
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29532450
- ISRCTN27916681_PIS_29Jan14_Portugese.pdf Uploaded 04/10/2016