Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement

Morality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04531839
• Other study ID #: SH-EPIQ 20200826
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

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;

Related Conditions & MeSH terms

• Morality
• Morbidity;Newborn
• Premature Birth

Intervention

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

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Children's Hospital of Shanghai Jiao Tong University	Shanghai	Shanghai
China	Obstetrics and Gynecoloy Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai Children's Medical Center	Shanghai	Shanghai
China	Shanghai First Maternity and Infant Hosipital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (5)

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

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. Erratum In: N Engl J Med. ;372(25):2469. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Length of NICU stay	days for the first NICU hospitalization	During first NICU hospitalization (about 1-4 months)