Implementation of the Golden Hour for Preterm Infants : a Quality Improvement Study
Implementation of the "Golden Hour", an Initial Standardized Stabilization of Preterm Less Than 31 Weeks and/or 1300 g : a Quality Improvement Study
1 other identifier
observational
50
1 country
1
Brief Summary
Effective initial stabilization of preterm neonates in the initial 60 minutes of life ("golden hour") was shown to improve outcomes. Keys components include anticipative and collaborative approach, respiratory support, thermal regulation and early initiation of parenteral nutrition. The objective is to complete the admission within 60 minutes of delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
1 active site
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
First Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedStudy Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 9, 2022
March 1, 2022
1.1 years
December 1, 2021
March 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Completion of the procedure : closing time of the incubator
Number of minutes of life at incubator closure
1 hour
Glycemia at admission and within 24 hours
blood glucose measurement on admission and then every 3 hours for the first 24 hours of life
24 hours
Thermal stability : temperature at admission and at the end of the procedure
1 hour
Mortality rate
3 months
Secondary Outcomes (9)
Process of the procedure:
1 hour
Incidence of hypotension and bradycardia
1 hour
Intubation rate and duration of mechanical ventilation
3 months
Need for surfactant administration and time of administration
3 days
Comorbidities of prematurity: NEC, BPD, ROP, sepsis, PDA, cPVL, IVH
3 months
- +4 more secondary outcomes
Study Arms (1)
premature infants
premature infants less than 31 weeks of gestation or weighting less than 1300 g
Interventions
This is a quality improvement project to evaluate the implementation of "Golden hour", a standardized stabilization during the first hour of life in inborn preterm infants younger than 31 weeks of gestational age or weighting less than 1300 g in the NICU of the University of Liege. There is no comparative arm.
Eligibility Criteria
Premature younger than 31 weeks of gestational age or less than 1300 g expected
You may qualify if:
- Premature infants (\< 31 weeks' gestation)
- Infants with expected weight less than 1300 g
- Inborn babies
You may not qualify if:
- Infants outborn
- Infants with major congenital anomalies (laparoschisis, omphalocèle, diaphragmatic hernia, …)
- Parental refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Liège
Liège, 4000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
December 1, 2021
First Posted
January 4, 2022
Study Start
January 10, 2022
Primary Completion
March 1, 2023
Study Completion
June 1, 2023
Last Updated
March 9, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share