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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
See additional files (available in Portuguese)
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
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
Neonatal morbidities
Overall study start date
01/02/2014
Overall study end date
28/02/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Preterms with less 34 weeks gestational age
Participant type(s)
Patient
Age group
Neonate
Sex
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
Study 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
ROR
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
Results published in 2017 thesis https://run.unl.pt/bitstream/10362/35458/1/Macedo%20Israel%20TD%202018.pdf
Intention to publish date
31/03/2017
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/01/2014 | 04/10/2016 | No | Yes | |
| Results article | results | 01/07/2018 | Yes | No |
Additional files
- ISRCTN27916681_PIS_29Jan14_Portugese.pdf Uploaded 04/10/2016