Speed of Increasing Milk Feeds Trial (SIFT)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
This study will compare two different rates of increase of milk feeds, one 'fast' and one 'slow', both within rates currently used in UK neonatal units with the aim to find out if either rate 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 NHS, including costs.
The study will be led by an established team of researchers who have run similar studies before, and will use an established network of neonatal units that have taken part in previous studies. Investigators are confident that there will be enough families wishing to take part in this study.
| Condition | Intervention |
|---|---|
|
Premature Birth Nosocomial Infections Necrotizing Enterocolitis |
Dietary Supplement: Milk feed (breast milk or formula milk) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-centre Randomised Controlled Trial of Two Rates of Daily Increment of Enteral Feeding to Prevent Late-onset Invasive Infection in Very Preterm or Low Birth Weight Infants |
- Survival without serious disability [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]
- Incidence of microbiologically-confirmed or clinically strongly-suspected late-onset invasive infection [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: Yes ]
- Incidence of necrotizing enterocolitis [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: Yes ]
- Time to reaching full milk feeds (defined as 150 ml/kg/day) [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]
- Growth at discharge [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]Measured by weight and head circumference z-scores
- Total duration of parenteral feeding before discharge from hospital [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]
- Number of days spent in intensive care [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]
- Duration of hospital stay [ Time Frame: Participants will be followed from enrolment to hospital discharge (typically at 36 corrected weeks' gestation), an expected average of 8 weeks. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | January 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Slow milk feed increment
Increase milk feeds by 18 ml/kg/day until full milk feeds of 150 ml/kg/day are achieved.
|
Dietary Supplement: Milk feed (breast milk or formula milk) |
|
Experimental: Fast milk feed increment
Increase milk feeds by 30 ml/kg/day until full milk feeds of 150ml/kg/day are achieved
|
Dietary Supplement: Milk feed (breast milk or formula milk) |
Eligibility| Ages Eligible for Study: | up to 32 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gestational age at birth less than 32 weeks, or less than 1500 g birth weight
- Receiving less than 24 ml/kg/day of milk at time of randomisation
- Written informed consent is obtained
Exclusion Criteria:
- Infants with severe congenital anomalies
- Infants not likely to survive or be traced for follow-up (e.g. non-UK residents)
Contacts and Locations| Contact: Elizabeth Bosiak | 01865 617 919 | elizabeth.bosiak@npeu.ox.ac.uk |
| Contact: Ursula Bowler | 01865 289 749 | ursula.bowler@npeu.ox.ac.uk |
| Principal Investigator: | Jon Dorling, MBChB DCH MD | Nottingham University Hospitals NHS Trust |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01727609 History of Changes |
| Other Study ID Numbers: | SIFT01 |
| Study First Received: | October 11, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee United Kingdom: National Institute for Health Research |
Keywords provided by University of Oxford:
|
Preterm Sepsis Feeding Enteral Milk |
Additional relevant MeSH terms:
|
Enterocolitis Premature Birth Cross Infection Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Infection |
ClinicalTrials.gov processed this record on May 16, 2013