Implementation of the Golden Hour for Preterm Infants : a Quality Improvement Study

Premature Birth Clinical Trial

Official title:

Implementation of the "Golden Hour", an Initial Standardized Stabilization of Preterm Less Than 31 Weeks and/or 1300 g : a Quality Improvement Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175911
• Other study ID #: Golden
• Status: Recruiting
• Start date: January 10, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Sophie Tribolet
• Phone: 003243215648
• Email: sophie.tribolet[@]chuliege.Be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

Inclusion Criteria:

• Premature infants (< 31 weeks' gestation)

• Infants with expected weight less than 1300 g

• Inborn babies

Exclusion Criteria:

• Infants outborn

• Infants with major congenital anomalies (laparoschisis, omphalocèle, diaphragmatic hernia, …)

• Parental refusal

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• golden hour : an initial standardized stabilization
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.

Locations

Country	Name	City	State
Belgium	CHU Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of the procedure : closing time of the incubator	Number of minutes of life at incubator closure	1 hour
Primary	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
Primary	Thermal stability : temperature at admission and at the end of the procedure		1 hour
Primary	Mortality rate		3 months
Secondary	Process of the procedure:	Number of minutes of life at initiation of parenteral nutrition, caffeine and antibiotics administration.	1 hour
Secondary	Incidence of hypotension and bradycardia		1 hour
Secondary	Intubation rate and duration of mechanical ventilation	Number of hours of mechanical ventilation	3 months
Secondary	Need for surfactant administration and time of administration	Number of hours of life at surfactant administration	3 days
Secondary	Comorbidities of prematurity: NEC, BPD, ROP, sepsis, PDA, cPVL, IVH		3 months
Secondary	Duration of hospital stay (only if no transfer)		3 months
Secondary	Caregiver's perception of the procedure: stress…	use of a questionnaire adapted from the "Teamwork Perceptions Questionnaire (T-TPQ)"	24 hours
Secondary	Parental experience of the procedure		24 hours
Secondary	Conditions of the procedure : realization during the night shift and team composition	collection of the time and date of performance and the number of nurses, doctors, fellows,...	24 hours