Neonatal InfectionNCT01729000
Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis
A study testing Gloves in people with Neonatal Infection and Neonatal Necrotizing Enterocolitis, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Read more about this study
- Who is it for?
- Ages Up to 8 days
- Conditions the study is for
- Neonatal Infection, Neonatal Necrotizing Enterocolitis
- What is being tested?
- Gloves
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight <1000 grams or gestational age ≤28 weeks
- less than or equal to 7 days of age
Who cannot join
- greater than 7 days of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia, Newborn Intensive Care Unit
Charlottesville, Virginia, 22932
About this study
Official title: Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis
The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Preterm infants <1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. The primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.
Read the detailed description
All infants who had a birth weight of less than or equal to 1000 grams or who were born less than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. Study signs were placed at the bedside and on the isolette sides of each infant with the appropriate study group guidelines.
The investigators goal was to target the time period these infants are at high-risk for infection or NEC and its associated mortality. The targeted time was the first 4 weeks of life or longer while intravenous access is still required. The average age for the first episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days; 95th percentile: 57 days). The majority of infections that occur after 4 weeks of life are in patients still requiring IV access (peripheral or central). The presence of an intravenous line in this group of preterm infants correlates with the presence of risk factors for infection that would necessitate the need for intravenous access including: parenteral nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself (if it is a central venous catheter). This strategy focused on the individual infant's risks, limits exposure to and decreases cost of intervention.
- Being tested
- Gloves
- Keywords
- prematurity, infection control, necrotizing entercolitis
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlovesOther
All staff must wear gloves for subjects that are in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Hand hygiene | No intervention | All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line. |
| Hand hygiene plus gloving | Experimental | All staff that have interaction with subjects will perform hand hygiene and wear gloves with all patient contact and before all contact with the intravenous line. Receives: Other: Gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Infection
Invasive infection will be defined as growth of bacteria from culture (blood, urine, CSF, peritoneal) with clinical signs and symptoms of sepsis
Measured: Participants will be followed during their NICU hospitalization, an expected average of 3 months
Necrotizing enterocolitis (NEC)
NEC will be defined as stage II or greater using Bell's modified criteria
Measured: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Secondary outcomes (4)
Length of stay
Length of stay will be compared in each study arm
Measured: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Mortality
Mortality will be compared in each study arm
Measured: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Hospital cost
Hospital costs will be compared in each study arm
Measured: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Common neonatal morbidities
Common morbidities will be compared in each study arm
Measured: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A Kaufman, University of Virginia
- Investigators
- David A Kaufman, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729000
- Sponsor's protocol ID
- 13971
- Status last verified
- Nov 2012
- First submitted
- 4 Mar 2011
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaufman DA, Blackman A, Conaway MR, Sinkin RA. Nonsterile glove use in addition to hand hygiene to prevent late-onset infection in preterm infants: randomized clinical trial. JAMA Pediatr. 2014 Oct;168(10):909-16. doi: 10.1001/jamapediatrics.2014.953.
PubMed 25111196
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gloving and Handwashing to Prevent Invasive Infections in Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT01729000
- Acronym / sponsor ID
- 13971
- Keywords
- prematurity, infection control, necrotizing entercolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a RCT. Preterm infants <1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. The primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. Secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.
Detailed description
All infants who had a birth weight of less than or equal to 1000 grams or who were born less than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. Study signs were placed at the bedside and on the isolette sides of each infant with the appropriate study group guidelines.
The investigators goal was to target the time period these infants are at high-risk for infection or NEC and its associated mortality. The targeted time was the first 4 weeks of life or longer while intravenous access is still required. The average age for the first episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days; 95th percentile: 57 days). The majority of infections that occur after 4 weeks of life are in patients still requiring IV access (peripheral or central). The presence of an intravenous line in this group of preterm infants correlates with the presence of risk factors for infection that would necessitate the need for intravenous access including: parenteral nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself (if it is a central venous catheter). This strategy focused on the individual infant's risks, limits exposure to and decreases cost of intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand hygiene | No intervention | –All staff that have interaction with subjects will perform hand hygiene with all patient contact and before all contact with the intravenous line. |
| Hand hygiene plus gloving | Experimental | Other: GlovesAll staff that have interaction with subjects will perform hand hygiene and wear gloves with all patient contact and before all contact with the intravenous line. |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight <1000 grams or gestational age ≤28 weeks
- less than or equal to 7 days of age
Key exclusion criteria (1 listed)
- greater than 7 days of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlovesAll staff must wear gloves for subjects that are in the experimental group. | Other | Hand hygiene plus gloving |
Primary outcome
Invasive Infection
Time frame: Participants will be followed during their NICU hospitalization, an expected average of 3 months
Invasive infection will be defined as growth of bacteria from culture (blood, urine, CSF, peritoneal) with clinical signs and symptoms of sepsis
Necrotizing enterocolitis (NEC)
Time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
NEC will be defined as stage II or greater using Bell's modified criteria
4 secondary outcomes
Length of stay
Time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Mortality
Time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Hospital cost
Time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Common neonatal morbidities
Time frame: Participants will be followed for their entire NICU hospitalization, which is an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Derived from this study: PubMed 25111196Kaufman DA, Blackman A, Conaway MR, Sinkin RA. Nonsterile glove use in addition to hand hygiene to prevent late-onset infection in preterm infants: randomized clinical trial. JAMA Pediatr. 2014 Oct;168(10):909-16. doi: 10.1001/jamapediatrics.2014.953.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Kaufman, MD principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gloves in people with Neonatal Infection and Neonatal Necrotizing Enterocolitis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Infection (time frame: Participants will be followed during their NICU hospitalization, an expected average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.