Effect on body and brain development of feeding very premature babies with breast milk containing different supplements
| ISRCTN | ISRCTN27916681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27916681 |
| Secondary identifying numbers | 2 |
- Submission date
- 10/01/2015
- Registration date
- 11/02/2015
- Last edited
- 18/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Public
Alam Qta Sto Antonio 5-N3-2Esq
Lisbon
1600-675
Portugal
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN27916681_PIS_29Jan14_Portugese.pdf |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 28/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Preterms with less 34 weeks gestational age |
| Key exclusion criteria | 1. Congenital malformations 2. Formula feeding 3. Inability to achieve full enteral feeding 4. Parents inability to understand informed consent |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 28/02/2015 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Lisbon
1069
Portugal
Sponsor information
Hospital/treatment centre
c/o Rosalina Barroso, MD
Hospital Prof. Doutor Fernando Fonseca
Amadora
2720-276
Portugal
"ROR" |
https://ror.org/00snfqn58 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
| IPD sharing plan |
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
Editorial Notes
18/05/2018: The following changes have been made:
1. Publication reference added.
2. Thesis added to publication and dissemination plan.
04/10/2016: The overall trial end date and recruitment end dates have been updated from 31/12/2014 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.
