None listed
Conditions
Brief summary
Infection in preterm babies (babies born early) remains a common problem in neonatal units – up to 1 in 4 babies born at less than 29 weeks of pregnancy develops a serious infection at some time during their stay. Preterm babies are vulnerable to infection, and the impact of infection can be far-reaching: not only can infection make babies critically unwell, but can also contribute to poorer health and development when babies grow up into childhood. It is crucial that neonatal units try to reduce infection rates. One of the main sources of infection comes from bugs that are usually carried on babies’ or healthcare workers’ skin. These bugs are carried harmlessly on the skin, but if they get into the bloodstream they can cause infection. The ‘Gloves On’ study is looking at a simple intervention to try to prevent infection: using gloves when staff touch babies in addition to the handwashing that we would normally do before we touch any baby. Gloves are not used routinely at present. We think using gloves would reduce infection by lowering the rate of transmission of bugs from healthcare workers’ hands to babies and back again. We would like to assess the impact of using gloves on infection rates in preterm babies, as well as making sure it is safe for babies, and safe and acceptable to the families and everyone who uses them. This simple and cheap intervention would be easy to introduce into every neonatal unit if it is shown to be successful and cost-effective. This would mean reduced numbers of infections in fragile preterm babies, with improved survival rates. Lower infection rates means shorter times in hospital for the babies and reduced costs for hospitals. Lower infection rates would also improve health and development of these babies when they grow into young children, making life better for families around Australia.
Interventions
Gloves On'
Sepsis continues to be a significant problem for preterm infants, and late-onset sepsis (LOS; sepsis with signs developing after 48 hours of life) contributes to the majority of infections. Hand contamination is the most common source of infection in neonatal LOS. Even after appropriate hand hygiene, microbes may remain present on the skin, but the use of clean non-sterile gloves may further reduce microbial contamination. Observational and small randomised controlled trial data that
Gloves On' Sepsis continues to be a significant problem for preterm infants, and late-onset sepsis (LOS; sepsis with signs developing after 48 hours of life) contributes to the majority of infections. Hand contamination is the most common source of infection in neonatal LOS. Even after appropriate hand hygiene, microbes may remain present on the skin, but the use of clean non-sterile gloves may further reduce microbial contamination. Observational and small randomised controlled trial data that non-sterile glove use in addition to hand hygiene prior to patient contact reduces late-onset sepsis rates in preterm infants and sick children. The intervention in the 'Gloves On' study is the use of non-sterile glove use in addition to hand hygiene prior to direct patient contact for all infants <29 weeks gestation. These encounters will include any non-sterile procedures including handling of infants (feeding and bathing), insertion or handling of peripheral intravenous cannulas, handling of central lines, and any time the cot/humidicrib is accessed. All patients included in the study will have signs indicating their study inclusion placed at the end of the cot/crib. During the intervention period of non-sterile glove use, alcohol rub as well as non-sterile gloves will be made available at every bed space to remind staff. Prior to every patient contact, hand hygiene and donning of non-sterile gloves will occur by staff members. Other indications for sterile glove use and hand hygiene are unchanged and as per individual unit policy. Non-sterile glove use is for health care professionals only. The intervention period is for the first 28 days of life, or while the infant has intravenous access in situ. Glove use and hand hygiene compliance will be monitored through each unit's hand hygiene auditors, who already collect this data for the National Hand Hygiene Audit.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
All infants born at <29 weeks completed gestational age at a participating NICU .
Exclusion criteria
No exclusions at a trial level. Parents may withdraw their infant from NICUs data collection if they wish.
Outcome results
None listed