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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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Survival of preterm infants has increased greatly over the years, so a major aim now is to improve the long term outlook for these babies and to avoid serious complications. The way babies are fed in early life affects short and long-term health and survival.
Because the bowels of preterm infants have not matured, they cannot digest large volumes of milk feeds straight away. Until the gut matures, nutrition is provided by intravenous drip while the amount of milk given is gradually increased over time. Increasing the amount of milk rapidly may increase the risk of gut complications. Increasing the amount of milk given more slowly means that intravenous nutrition is needed for longer; there is an associated risk of infection proportional to the time the intravenous line is present in the bloodstream of these infants. Despite the importance of milk feeding preterm infants, there have been few studies to inform how best to balance these risks, and what the best way to increase feeds in these infants is - this study sets out to address this missing information.
The study will compare two different speeds of milk feed increase, one 'faster' and one 'slower', both within rates currently used in United Kingdom neonatal units. The study aims to find out if either speed of milk feed increase gives better outcomes for the infants. Investigators will measure a variety of outcomes, such as survival without disability, infection, bowel problems, growth and long-term physical and mental development, as well as the impact on families and the National Health Service, including costs.
The study is being led by an established team of researchers who have run similar studies before, and uses an established network of neonatal units that have taken part in previous studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slower milk feed increment | Active Comparator | Increase milk feeds by 18 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days) |
|
| Faster milk feed increment | Experimental | Increase milk feeds by 30 ml/kg/day until on full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk feed (breast milk or formula milk) | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival without moderate or severe disability | 24 months of age corrected for prematurity |
| Measure | Description | Time Frame |
|---|---|---|
| Survival to discharge home | Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. | |
| Incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection |
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Inclusion Criteria:
To ensure the widest applicability to preterm infants across the United Kingdom, those exclusively breast milk fed, formula milk fed, or receiving mixed feeds will be included
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Dorling, MBChB DCH MD | Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Maternity Hospital, Dublin | Dublin | Dublin 2 | Ireland | |||
| William Harvey Hospital |
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| Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. |
| Incidence of necrotizing enterocolitis (Bell stage 2 or 3) | Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. |
| Time taken to reach full milk feeds (tolerating 150 ml/kg/day for 3 consecutive days) | Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. |
| Growth (weight and head circumference) at hospital discharge | Measured by weight and head circumference z-scores | Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. |
| Duration of parenteral feeding before hospital discharge | Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. |
| Length of time in intensive care | Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. |
| Length of hospital stay | Participants will be followed from trial entry until hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. |
| Ashford |
| TN24 0LZ |
| United Kingdom |
| Royal Maternity Hospital, Belfast | Belfast | BT12 6BB | United Kingdom |
| Birmingham Women's Hospital | Birmingham | B15 2TG | United Kingdom |
| Birmingham City Hospital | Birmingham | B18 7QH | United Kingdom |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| St Michael's Hospital | Bristol | S2 8EG | United Kingdom |
| St Peters Hospital | Chertsey | KT16 0PZ | United Kingdom |
| Countess of Chester Hospital | Chester | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Leighton Hospital | Crewe | United Kingdom |
| Derbyshire Children's Hospital | Derby | DE22 3NE | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| Princess Royal Maternity Hospital, Glasgow | Glasgow | G31 2ER | United Kingdom |
| Southern General Hospital | Glasgow | G51 4TF | United Kingdom |
| Gloucestershire Royal Hosptial | Gloucester | United Kingdom |
| Calderdale Royal Hospital | Halifax | HX3 0PW | United Kingdom |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| Kettering General Hospital | Kettering | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Lincoln County Hospital | Lincoln | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Altnagelvin Area Hospital | Londonderry | BT47 6SB | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Royal Victoria Infirmary | Newcastle | NE1 4LP | United Kingdom |
| Northampton General Hospital | Northampton | United Kingdom |
| Nottingham City Hospital | Nottingham | United Kingdom |
| Queen's Medical Centre | Nottingham | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Derriford Hospital | Plymouth | United Kingdom |
| Craigavon Area Hospital | Portadown | United Kingdom |
| Queen Alexandra Hospital, Portsmouth | Portsmouth | PO6 3LY | United Kingdom |
| Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| Queen's Hospital, Romford | Romford | RM7 0AG | United Kingdom |
| Jessop Wing, Sheffield | Sheffield | S10 2SF | United Kingdom |
| Royal Shrewsbury Hospital | Shrewsbury | SY3 8XQ | United Kingdom |
| Princess Anne Hospital, Southampton | Southampton | SO16 5YA | United Kingdom |
| University Hospital of North Tees | Stockton-on-Tees | TS19 8PE | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Sunderland Royal Hospital | Sunderland | SR4 7TP | United Kingdom |
| King's Mill Hospital | Sutton in Ashfield | United Kingdom |
| Singleton Hospital | Swansea | SA2 8QA | United Kingdom |
| Great Western Hospital, Swindon | Swindon | SN3 6BB | United Kingdom |
| Croydon University Hospital | Thornton Heath | CR7 7YE | United Kingdom |
| Royal Cornwall Hospital | Truro | United Kingdom |
| Arrowe Park Hospital, Wirral | Upton | CH49 5PE | United Kingdom |
| Pinderfields General Hospital | Wakefield | United Kingdom |
| Warrington Hospital | Warrington | United Kingdom |
| Wishaw General Hospital | Wishaw | ML2 0DP | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| Worcestershire Royal Hospital | Worcester | United Kingdom |
| York Hospital | York | YO31 8HE | United Kingdom |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D020345 | Enterocolitis, Necrotizing |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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