Extrait

Background and study aims Very low birth weight infants (infants less than 1500grams) can initially only tolerate small amounts of oral feeds due to their immature digestive systems. Feeds (breast milk or formula) are given through a tube (passed from the nose down into the stomach) and are slowly increased over the first weeks of life until full feeds are reached. Adequate nutrition during this time is important for growth and can affect important outcomes such as development. For this reason babies are given intravenous nutrition while feeds are being increased. This is called parenteral nutrition and is best given through a central line [Central Venous Catheter (CVC)]. A CVC is inserted in the first few days of life and delivers this nutritional fluid into a large vein near the heart. If parenteral nutrition leaks out of small veins it can damage the delicate surrounding tissue. Larger veins are better able to tolerate this concentrated fluid. CVCs also last much longer than peripheral lines and venous access is usually limited in these tiny infants. Peripherally Inserted Central Venous Catheters (PICC lines) are central lines inserted into a large blood vessel through the skin and are the preferred type of CVC in many neonatal units. All babies lose some weight in the first week of life and the time to regain birth-weight is a good marker of early post-natal (after birth) nutrition. Birth-weight is normally regained after about 11 days. The main outcome in this study will be to see if there is a significant difference, approximately 2 days, in the time it takes to regain birth weight between the babies who have their PICC line removed and parenteral nutrition stopped at 100mls/kg/day versus 140mls/kg/day (i.e. full feeds). If we show that there is no significant difference in nutritional outcomes between babies in both groups, then removing PICC lines earlier should help to reduce the risk of infection without negatively affecting nutrition. Who can participate? All babies less than 1500grams who have a PICC line inserted and are initiating oral feeding can participate. What does the study involve? Babies in this study will be randomly allocated to have their PICC line removed and parenteral nutrition stopped at either 100mls/kg/day (intervention group) or 140mls/kg/day (control group). Their treatment and care will otherwise be the same. No one will know which group a baby is in until an envelope, telling the doctor at what feeding volume the PICC line is to be removed, is opened. Once babies have reached full feeds, there will be no difference in the treatment they receive.A doctor will assess each baby prior to the PICC line being removed. If there is some medical reason why intravenous access is required then the PICC line will not be removed. Babies in the study will not have any extra tests or treatments compared to babies who do not participate in the study. What are the possible benefits and risks of participating? The benefit of continuing parenteral nutrition until full oral feeding (140mls/kg/day) is achieved is that maximal nutrition for growth is delivered. However, the longer the PICC line is in place and parenteral nutrition is delivered, the greater the risk of infection and other PICC line complications. There is no evidence to suggest that stopping parenteral nutrition at 100mls/kg/day oral feeds negatively affect sugar levels or hydration status. However, babies will be monitored for these complications and can be quickly managed if they occur. Where is the study run from? The study is run from two tertiary level neonatal centres in Dublin, Ireland. These are the Coombe Women and Infant’s University Hospital (CWIUH) and the National Maternity Hospital (NMH), Holles Street. The CWIUH is the lead centre. We plan to enrol 70 babies from each centre, 140 babies in total. When is the study starting and how long is it expected to run? This study plans to start in June 2013 and will continue until 140 babies are recruited. This will take approximately one year. Who is funding the study? Coombe Women and Infant's University Hospital Who is the main contact? Dr. Lucy Perrem: [email protected], [email protected] Dr. Jan Miletin, is the Clinical Director of Newborn Medicine in the CWIUH and is the lead supervisor: [email protected]

Critère d'inclusion

• Very Low Birth Weight / extremely premature infants: Nutrition and Late onset sepsis (LOS), CVC/PICC complications

Liens

• ictrp
• isrctn