Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement

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

Study Overview

• Status: Withdrawn
• Conditions: Morbidity;Newborn; Morality
• Intervention / Treatment: Behavioral: Evidence-based collaborative quality improvement

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Cao, MD,PHD; Phone Number: 1160 862164931990; Email: yuncao@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Obstetrics and Gynecoloy Hospital of Fudan University
    • Shanghai, Shanghai, China, 200062
      • Children's Hospital of Shanghai Jiao Tong University
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China, 200126
      • Shanghai First Maternity and Infant Hosipital
    • Shanghai, Shanghai, China, 200127
      • Shanghai Children's Medical Center
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Infants born at >=24+0 weeks' gestation and <32+0 weeks' gestation;
2. Admitted to the participating NICUs within 7 days after birth during study period

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention period; 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; Evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning
No Intervention: Baseline period; The 2-year period before the collaborative quality improvement intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the procedure (about 1-4 months)
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	During first NICU hospitalization (about 1-4 months)
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	During first NICU hospitalization (about 1-4 months)
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	During first NICU hospitalization (about 1-4 months)
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.	During first NICU hospitalization (about 1-4 months)
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	During first NICU hospitalization (about 1-4 months)
Length of NICU stay	days for the first NICU hospitalization	During first NICU hospitalization (about 1-4 months)

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Shanghai Children's Medical Center; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Obstetrics & Gynecology Hospital of Fudan University; Shanghai First Maternity and Infant Hospital

Publications and helpful links

General 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. Erratum In: N Engl J Med. ;372(25):2469.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mortality; Very preterm infant; Quality improvement; Morbidities
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: SH-EPIQ 20200826

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No