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Nosocomial InfectionsNCT02600195

Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality

A study testing Evidence-based Practice for Improving Quality (EPIQ) method in people with Nosocomial Infections, run by Children's Hospital of Fudan University at 24 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 4-year cluster randomized controlled trial aims to determine whether implementation of Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired infection in Chinese Neonatal Intensive Care Units (NICUs). Read more about this study

Who is it for?
Ages Up to 120 days
Conditions the study is for
Nosocomial Infections
What is being tested?
Evidence-based Practice for Improving Quality (EPIQ) method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,600 participants
Where
24 sitesChina
Study dates
May 2015to 30 Apr 2018
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 120 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants born at <34 weeks' gestation
  • Admitted to the participating NICUs within 7 days after birth
  • Admitted to the participating NICUs between May 1, 2015 and April 30, 2018

Who cannot join

  • Infants with major congenital anomalies
  • Infants who are moribund on admission (a decision is made to provide only palliative care)

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Beijing Children's Hospital

    Beijing, Beijing Municipality

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Fujian Maternity and Child Health Care Hospital

    Fuzhou, Fujian

  • Guiyang Children's Hospital

    Guiyang, Guizhou

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Jinan Children's Hospital

    Jinan, Shandong

  • Gansu Maternity and Child Health Care Hospital

    Lanzhou, Gansu

  • Jiangxi Children's Hospital

    Nanchang, Jiangxi

  • Nanjing Children's Hospital

    Nanjing, Jiangsu

  • Nanjing Maternity and Child Health Care Hospital

    Nanjing, Jiangsu

  • Guangxi Maternity and Child Health Care Hospital

    Nanning, Guangxi

  • Qingdao Maternity and Child Health Care Hospital

    Qingdao, Shandong

  • Shanghai First Maternity and Child Health Care Hospital

    Shanghai

  • Shenzhen Maternity and Child Health Care Hospital

    Shenzhen, Guangdong

  • Children's Hospital of Hebei Province

    Shijiazhuang, Hebei

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu

  • Shanxi Maternity and Child Health Care Hospital

    Taiyuan, Shanxi

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • The Second Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang

  • Hubei Maternity and Child Health Care Hospital

    Wuhan, Hubei

  • Tongji Hospital Affiliated to Tongji Medical College

    Wuhan, Hubei

  • Wuxi Maternity and Child Health Care Hospital

    Wuxi, Jiangsu

  • Shanxi Maternity and Child Health Care Hospital

    Xian, Shanxi

  • Zhengzhou Children's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial

This 4-year cluster randomized controlled trial aims to determine whether implementation of Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired infection in Chinese Neonatal Intensive Care Units (NICUs).

Read the detailed description

Following randomization into two groups, the intervention NICUs (n = 12) will receive training in the EPIQ method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support. Control NICUs (n = 12) will collect neonatal data and continue to provide standard care. Study subjects will be all preterm infants born at <34 weeks' gestation and admitted to participating NICUs during the trial (estimated n = 5,200 per year). Data analysis will be conducted to compare neonatal outcomes and health-care resources used between the intervention and control groups.

Being tested
Evidence-based Practice for Improving Quality (EPIQ) method
Keywords
Intensive Care, Neonatal, Nosocomial Infections, Quality Improvement
Medical subject headings
Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evidence-based Practice for Improving Quality (EPIQ) methodBehavioural

    The intervention NICUs (n = 12) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support.

Study groups in NCT02600195
Study groupRoleWhat they receive
EPIQ sitesExperimentalUse Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection
Receives: Behavioral: Evidence-based Practice for Improving Quality (EPIQ) method
Control sitesNo interventionContinue current practices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of hospital-acquired infection

    Combined cases of following types of hospital-acquired infection: ventilation associated pneumonia, central line-associated blood stream infection (CLABSI), blood stream infections excluding CLABSI, urinary tract infections, meningitis, clinical sepsis

    Measured: Three years

Secondary outcomes (13)

  1. Incidence of ventilation associated pneumonia

    Measured: Three years

  2. Incidence of central line-associated blood stream infection

    Measured: Three years

  3. Incidence of blood stream infection excluding CLABSI

    Measured: Three years

  4. Incidence of meningitis

    Measured: Three years

  5. Incidence of clinical sepsis

    Measured: Three years

  6. Incidence of urinary tract infections

    Measured: Three years

  7. Incidence of stage ≥2 necrotizing enterocolitis

    Measured: Three years

  8. Days on ventilation support

    Measured: Three years

  9. Days on total parenteral nutrition

    Measured: Three years

  10. Days on antibiotics

    Measured: Three years

  11. Days on inotropes

    Measured: Three years

  12. All cause mortality

    Measured: Three years

  13. Infection-related mortality

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionApr 2018
  4. Study completion30 Apr 2018

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02600195
Sponsor's protocol ID
14-194
Status last verified
Aug 2018
First submitted
5 Nov 2015
Last updated
7 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee SK, Aziz K, Singhal N, Cronin CM, James A, Lee DS, Matthew D, Ohlsson A, Sankaran K, Seshia M, Synnes A, Walker R, Whyte R, Langley J, MacNab YC, Stevens B, von Dadelszen P. Improving the quality of care for infants: a cluster randomized controlled trial. CMAJ. 2009 Oct 13;181(8):469-76. doi: 10.1503/cmaj.081727. Epub 2009 Aug 10.

    PubMed 19667033

  • Zhou Q, Lee SK, Jiang SY, Chen C, Kamaluddeen M, Hu XJ, Wang CQ, Cao Y. Efficacy of an infection control program in reducing ventilator-associated pneumonia in a Chinese neonatal intensive care unit. Am J Infect Control. 2013 Nov;41(11):1059-64. doi: 10.1016/j.ajic.2013.06.007. Epub 2013 Sep 14.

    PubMed 24041863

  • Polin RA, Denson S, Brady MT; Committee on Fetus and Newborn; Committee on Infectious Diseases. Strategies for prevention of health care-associated infections in the NICU. Pediatrics. 2012 Apr;129(4):e1085-93. doi: 10.1542/peds.2012-0145. Epub 2012 Mar 26.

    PubMed 22451712

  • Fanaroff AA, Hack M, Walsh MC. The NICHD neonatal research network: changes in practice and outcomes during the first 15 years. Semin Perinatol. 2003 Aug;27(4):281-7. doi: 10.1016/s0146-0005(03)00055-7.

    PubMed 14510318

  • Horbar JD, Soll RF, Edwards WH. The Vermont Oxford Network: a community of practice. Clin Perinatol. 2010 Mar;37(1):29-47. doi: 10.1016/j.clp.2010.01.003.

    PubMed 20363446

  • Peng W, Han J, Li S, Zhang L, Yang C, Guo J, Cao Y. The Association of Human Milk Feeding With Short-Term Health Outcomes Among Chinese Very/Extremely Low Birth Weight Infants. J Hum Lact. 2022 Nov;38(4):670-677. doi: 10.1177/08903344221078237. Epub 2022 Mar 2.

    PubMed 35236170

  • Luo N, Jiang S, McNamara PJ, Li X, Guo Y, Wang Y, Han J, Deng Y, Yang Y, Lee SK, Cao Y. Cardiovascular Pharmacological Support Among Preterm Infants in Chinese Referral Center Neonatal Intensive Care Units. Front Pediatr. 2021 Apr 22;9:638540. doi: 10.3389/fped.2021.638540. eCollection 2021.

    PubMed 33968845

  • Peng W, Jiang S, Li S, Xia S, Chen S, Yang Y, Lee SK, Cao Y. Human Milk Feeding Status of Preterm Infants in Neonatal Intensive Care Units in China. J Hum Lact. 2020 May;36(2):283-290. doi: 10.1177/0890334419901265. Epub 2020 Feb 20.

    PubMed 32078781

Questions about this trial

What is this clinical trial studying?

A study testing Evidence-based Practice for Improving Quality (EPIQ) method in people with Nosocomial Infections, run by Children's Hospital of Fudan University at 24 sites in China.

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 3 inclusion and 2 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. 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?

Incidence of hospital-acquired infection (time frame: Three years). 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 NCT02600195, which also lists 8 linked publications.

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 7 Aug 2018.

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