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Morbidity;NewbornNCT04531839

Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement

A study testing Evidence-based collaborative quality improvement in people with Morbidity;Newborn and Morality, run by Children's Hospital of Fudan University at 6 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants in six neonatal centers in Shanghai Read more about this study

Who is it for?
Ages Up to 120 days
Conditions the study is for
Morbidity;Newborn, Morality
What is being tested?
Evidence-based collaborative quality improvement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
6 sitesChina
Study dates
1 Oct 2024to 30 Sep 2026
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 >=24+0 weeks' gestation and <32+0 weeks' gestation;
  • Admitted to the participating NICUs within 7 days after birth during study period

Who cannot join

  • Infants with major congenital anomalies;
  • Infants who transferred to non-participating hospitals within 24 hours after birth;

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Obstetrics and Gynecoloy Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200011

  • Children's Hospital of Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200062

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Shanghai First Maternity and Infant Hosipital

    Shanghai, Shanghai Municipality, 200126

  • Shanghai Children's Medical Center

    Shanghai, Shanghai Municipality, 200127

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

Other trials in China

About this study

Official title: Improving the Outcome of Very Preterm Infants Using Evidence-based Collaborative Quality Improvement: A Multi-center Prospective Study

A multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants in six neonatal centers in Shanghai

Read the detailed description

A multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants using evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning.

Being tested
Evidence-based collaborative quality improvement
Keywords
Very preterm infant, Quality improvement, Mortality, Morbidities

What participants receive

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

  • Evidence-based collaborative quality improvementBehavioural

    Evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning

Study groups in NCT04531839
Study groupRoleWhat they receive
Intervention periodExperimentalThe 1.5-year period during which all six participating centers receive evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation, and collaborative learning
Receives: Behavioral: Evidence-based collaborative quality improvement
Baseline periodNo interventionThe 2-year period before the collaborative quality improvement intervention

What is being measured

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

  1. Mortality or any major morbidity

    It is a binary varibale (1/0). The variabel would be setted into "1",if death or with any of the following major morbidities: bronchopulmonary dysplasia, necrotizing stage II or above, retinopathy of prematurity stage III or above, intraventricular hemorrhage grade III or above or cystic periventricular leukomalacia and late-onset epsis

    Measured: During first NICU hospitalization (about 1-4 months)

Secondary outcomes (7)

  1. Mortality

    It is a binary varibale (1/0). The variabel would be setted into "1",if patients dead during hospitalization or 28 days after discharge against medical advice

    Measured: During the procedure (about 1-4 months)

  2. Bronchopulmonary dysplasia

    It is a binary varibale (1/0). The variabel would be setted into "1",if patients reveived respiratory support or oxygen at 36 weeks' corrected gestational age or on discharge

    Measured: During first NICU hospitalization (about 1-4 months)

  3. Necrotizing enterocolitis

    It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with NEC stage II or above

    Measured: During first NICU hospitalization (about 1-4 months)

  4. Severe brain injury

    It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with intraventricular hemorrhage grade III or above within 28 days after birth or cystic periventricular leukomalacia

    Measured: During first NICU hospitalization (about 1-4 months)

  5. Retinopathy of prematurity

    It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with ROP stage III or above.

    Measured: During first NICU hospitalization (about 1-4 months)

  6. Late-onset sepsis

    It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with culture-proven sepsis after 72 hours after birth

    Measured: During first NICU hospitalization (about 1-4 months)

  7. Length of NICU stay

    days for the first NICU hospitalization

    Measured: During first NICU hospitalization (about 1-4 months)

Timeline

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

  1. First posted31 Aug 2020
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Why it stopped: lack of funding

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04531839
Sponsor's protocol ID
SH-EPIQ 20200826
Status last verified
Jan 2024
First submitted
26 Aug 2020
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rysavy MA, Li L, Bell EF, Das A, Hintz SR, Stoll BJ, Vohr BR, Carlo WA, Shankaran S, Walsh MC, Tyson JE, Cotten CM, Smith PB, Murray JC, Colaizy TT, Brumbaugh JE, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Between-hospital variation in treatment and outcomes in extremely preterm infants. N Engl J Med. 2015 May 7;372(19):1801-11. doi: 10.1056/NEJMoa1410689.

    PubMed 25946279

  • Smith LK, Blondel B, Van Reempts P, Draper ES, Manktelow BN, Barros H, Cuttini M, Zeitlin J; EPICE Research Group. Variability in the management and outcomes of extremely preterm births across five European countries: a population-based cohort study. Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F400-F408. doi: 10.1136/archdischild-2016-312100. Epub 2017 Feb 23.

    PubMed 28232518

  • Soll RF, McGuire W. Evidence-Based Practice: Improving the Quality of Perinatal Care. Neonatology. 2019;116(3):193-198. doi: 10.1159/000496214. Epub 2019 Jun 5.

    PubMed 31167207

  • Zeitlin J, Manktelow BN, Piedvache A, Cuttini M, Boyle E, van Heijst A, Gadzinowski J, Van Reempts P, Huusom L, Weber T, Schmidt S, Barros H, Dillalo D, Toome L, Norman M, Blondel B, Bonet M, Draper ES, Maier RF; EPICE Research Group. Use of evidence based practices to improve survival without severe morbidity for very preterm infants: results from the EPICE population based cohort. BMJ. 2016 Jul 5;354:i2976. doi: 10.1136/bmj.i2976.

    PubMed 27381936

  • Zaka N, Alexander EC, Manikam L, Norman ICF, Akhbari M, Moxon S, Ram PK, Murphy G, English M, Niermeyer S, Pearson L. Quality improvement initiatives for hospitalised small and sick newborns in low- and middle-income countries: a systematic review. Implement Sci. 2018 Jan 25;13(1):20. doi: 10.1186/s13012-018-0712-2.

    PubMed 29370845

  • 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

  • Lee SK, Beltempo M, McMillan DD, Seshia M, Singhal N, Dow K, Aziz K, Piedboeuf B, Shah PS; Evidence-based Practice for Improving Quality Investigators. Outcomes and care practices for preterm infants born at less than 33 weeks' gestation: a quality-improvement study. CMAJ. 2020 Jan 27;192(4):E81-E91. doi: 10.1503/cmaj.190940.

    PubMed 31988152

Questions about this trial

What is this clinical trial studying?

A study testing Evidence-based collaborative quality improvement in people with Morbidity;Newborn and Morality, run by Children's Hospital of Fudan University at 6 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 2 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: withdrawn, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 was withdrawn before enrolling participants, so there are no results.

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?

Mortality or any major morbidity (time frame: During first NICU hospitalization (about 1-4 months)). 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 NCT04531839, which also lists 7 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 16 Jan 2024.

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