NCT04531839

Brief 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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
5mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2024Sep 2026

First Submitted

Initial submission to the registry

August 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
4.1 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

August 26, 2020

Last Update Submit

January 11, 2024

Conditions

Morbidity;NewbornMorality

Keywords

Very preterm infantQuality improvementMortalityMorbidities

Outcome Measures

Primary Outcomes (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

    During first NICU hospitalization (about 1-4 months)

Secondary Outcomes (7)

  • Mortality

    During the procedure (about 1-4 months)

  • Bronchopulmonary dysplasia

    During first NICU hospitalization (about 1-4 months)

  • Necrotizing enterocolitis

    During first NICU hospitalization (about 1-4 months)

  • Severe brain injury

    During first NICU hospitalization (about 1-4 months)

  • Retinopathy of prematurity

    During first NICU hospitalization (about 1-4 months)

  • +2 more secondary outcomes

Study Arms (2)

Intervention period

EXPERIMENTAL

The 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

Behavioral: Evidence-based collaborative quality improvement

Baseline period

NO INTERVENTION

The 2-year period before the collaborative quality improvement intervention

Interventions

Evidence-based collaborative quality improvementBEHAVIORAL

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

Intervention period

Eligibility Criteria

AgeUp to 120 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Obstetrics and Gynecoloy Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Children's Hospital of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200062, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai First Maternity and Infant Hosipital

Shanghai, Shanghai Municipality, 200126, China

Location

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (7)

  • 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.

    PMID: 25946279BACKGROUND

  • 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.

    PMID: 28232518BACKGROUND

  • 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.

    PMID: 31167207BACKGROUND

  • 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.

    PMID: 27381936BACKGROUND

  • 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.

    PMID: 29370845BACKGROUND

  • 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.

    PMID: 24041863BACKGROUND

  • 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.

    PMID: 31988152BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 31, 2020

Study Start

October 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 16, 2024

Record last verified: 2024-01

Locations

CN(6)