Clinical trial NCT04531839: Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement
Official title: Improving the Outcome of Very Preterm Infants Using Evidence-based Collaborative Quality Improvement: A Multi-center Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Morbidity;Newborn
Morality
Keywords: Very preterm infant
Quality improvement
Mortality
Morbidities
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Medical Center
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Obstetrics & Gynecology Hospital of Fudan University
name: Shanghai First Maternity and Infant Hospital
First posted: 2020-08-31
Enrollment: 0
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Mortality or any major morbidity
timeFrame: During first NICU hospitalization (about 1-4 months)
Secondary outcomes:
measure: Mortality
timeFrame: During the procedure (about 1-4 months)
measure: Bronchopulmonary dysplasia
timeFrame: During first NICU hospitalization (about 1-4 months)
measure: Necrotizing enterocolitis
timeFrame: During first NICU hospitalization (about 1-4 months)
measure: Severe brain injury
timeFrame: During first NICU hospitalization (about 1-4 months)
measure: Retinopathy of prematurity
timeFrame: During first NICU hospitalization (about 1-4 months)
measure: Late-onset sepsis
timeFrame: During first NICU hospitalization (about 1-4 months)
measure: Length of NICU stay
timeFrame: During first NICU hospitalization (about 1-4 months)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecoloy Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hosipital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.