Preterm milk Fortification in Neonates
| ISRCTN | ISRCTN22484792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22484792 |
| IRAS number | 293189 |
| Secondary identifying numbers | IRAS 293189, CPMS 50596 |
- Submission date
- 23/04/2021
- Registration date
- 01/10/2021
- Last edited
- 20/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English Summary
Background and study aims
Preterm and small babies often struggle to grow on breast milk (maternal or donor) alone, and commercially available cows milk-based fortifiers are currently added to breast milk to help growth. A human-based powdered fortifier is now commercially available.
Who can participate?
Infants born at less than 32 weeks gestation who have never received a cows milk-based diet (formula or fortifier) and have established full milk feeds
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). Infants in each group will receive one of two nutritionally equivalent fortifiers as a supplement to breast milk for babies born before 32 weeks gestation or weighing less than 1500 g at birth. One fortified supplement will be a standard cows milk-based product and the other a human-based product.
Infants will receive the fortified supplement from the start of the infants being fully fed on breast milk (when they have no intravenous feeds and are tolerating 150 ml/kg/day of milk) until 36 weeks gestation, or when a fortifier is no longer required, whichever is earlier. Mothers in both groups will be fully supported to provide their own breast milk, and any shortfall will be made up with standard human donor milk. No other changes to infant or mother care will take place. This study will compare gut inflammation through measures of stool samples (and blood/urine where available) and other outcomes until discharge from the neonatal unit.
What are the possible benefits and risks of participating?
The study group is preterm infants where growth and gut health are challenging. The study aims to promote optimal growth and minimise gut problems by comparing human milk based fortification to cows milk based fortification. The measures of growth are weight and the measures of gut problems are laboratory measures undertaken on stool. Preterm infants are fortified with cows milk based products currently, the human product is the new intervention and the hope is that because it does not contain non-human protein it will be better tolerated by the infants.
Where is the study run from?
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) and will be run in neonatal units in 3 UK hospitals
When is the study starting and how long is it expected to run for?
From January 2021 to April 2023
Who is funding the study?
NeoKare Nutrition Ltd (UK)
Who is the main contact?
Dr Janet Berrington
janet.berrington1@nhs.net
Contact information
Scientific
Neonatal Unit (Ward 35)
Royal Victoria Infirmary
Richardson Road
Newcastle
NE1 4LP
United Kingdom
 ORCID ID |
0000-0002-6185-2843 |
|---|---|
| Phone | +44 (0)1912829323 |
| janet.berrington1@nhs.net |
Study information
| Study design | Multi centre non-blinded randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Breastmilk fortification in preterm infants: a randomised controlled trial of two nutritionally equivalent fortifiers |
| Study acronym | PUFFIN |
| Study hypothesis | Human milk based fortifier for preterm infants will result in less gut inflammation than the standard cow milk based fortifier currently in use in the UK as measured by stool calprotectin |
| Ethics approval(s) | Approved 21/10/2021, Yorkshire & The Humber - Sheffield Research Ethics Committee (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ, UK; +44 (0)207 104 8388; sheffield.rec@hra.nhs.uk), ref: 21/YH/0224 |
| Condition | Preterm gut inflammation and other outcomes of prematurity (growth, length of hospital stay) |
| Intervention | Babies born at <32 weeks gestation or <1500 g birthweight will be randomised using Sealed envelope (a commercial randomisation company) to one of two groups to receive: 1. Standard cows milk-based fortified supplement to breast milk 2. Human-based product fortified supplement to breast milk The intervention will run from when the infants are being fully fed on breast milk (when they have no intravenous feeds and are tolerating 150 ml/kg/day of milk) until 36 weeks gestation, or when a fortifier is no longer required, whichever is earlier. Mothers in both groups will be fully supported to provide their own breast milk, and any shortfall will be made up with standard human donor milk. No other changes to infant or mother care will take place. This study will compare gut inflammation through measures of stool samples (and blood/urine where available) and other outcomes until discharge from the neonatal unit. |
| Intervention type | Supplement |
| Primary outcome measure | Faecal calprotectin measured from stool samples collected at baseline and 1 and 3 weeks after the intervention (until 36 weeks gestation, or when a fortifier is no longer required, whichever is earlier) |
| Secondary outcome measures | 1. Faecal sIgA, cytokine panel, and bacterial taxa (by 16srRNA) measured from stool samples collected at baseline and 1 and 3 weeks after intervention 2. Infant health measured using records of growth, morbidities associated with preterm birth, length of hospital stay, and biochemical results between baseline until discharge from the neonatal unit |
| Overall study start date | 01/01/2021 |
| Overall study end date | 28/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 36 |
| Participant inclusion criteria | 1. Born at <32 weeks gestation 2. Never received cow milk-based diet (formula or fortifier) and having established full milk feeds |
| Participant exclusion criteria | 1. Previous necrotising enterocolitis or gut surgery or malformation 2. Previous receipt of cow milk based diet (formula or fortifier) |
| Recruitment start date | 01/03/2022 |
| Recruitment end date | 28/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Royal Victoria Infirmary
Richardson Road
Newcastle
NE1 4LP
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Southampton
SO16 5YA
United Kingdom
Sponsor information
Hospital/treatment centre
Richardson Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Phone | +44 (0)1912825789 |
|---|---|
| aaron.jackson@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 28/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We aim to publish in peer reviewed journals. Participants will be signposted to results via websites but not individually informed. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
20/02/2024: Ethics approval details added.
21/06/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2021 to 01/03/2022.
2. The recruitment end date was changed from 01/06/2022 to 28/02/2023.
3. The overall trial end date was changed from 31/08/2022 to 28/04/2023.
4. The intention to publish date was changed from 01/12/2023 to 28/04/2024.
01/11/2021: The CPMS number was added.
27/08/2021: Trial’s existence confirmed by NeoKare Nutrition Ltd.
