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

• Conditions: Premature Birth

• Registration Number: NCT05175911
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-04
• Study Start: 2022-01-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-09
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality rate	3 months
Glycemia at admission and within 24 hours	24 hours	blood glucose measurement on admission and then every 3 hours for the first 24 hours of life
Thermal stability : temperature at admission and at the end of the procedure	1 hour
Completion of the procedure : closing time of the incubator	1 hour	Number of minutes of life at incubator closure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Liège; 🇧🇪 Liège, Belgium