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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth
• Intervention / Treatment: Other: golden hour : an initial standardized stabilization

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Sophie Tribolet; Phone Number: 003243215648; Email: sophie.tribolet@chuliege.Be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • Chu Liege
    • Contact: Sophie Tribolet; Email: sophie.tribolet@chuliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 hour (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature younger than 31 weeks of gestational age or less than 1300 g expected

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
premature infants; premature infants less than 31 weeks of gestation or weighting less than 1300 g	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process of the procedure:	Number of minutes of life at initiation of parenteral nutrition, caffeine and antibiotics administration.	1 hour
Incidence of hypotension and bradycardia		1 hour
Intubation rate and duration of mechanical ventilation	Number of hours of mechanical ventilation	3 months
Need for surfactant administration and time of administration	Number of hours of life at surfactant administration	3 days
Comorbidities of prematurity: NEC, BPD, ROP, sepsis, PDA, cPVL, IVH		3 months
Duration of hospital stay (only if no transfer)		3 months
Caregiver's perception of the procedure: stress…	use of a questionnaire adapted from the "Teamwork Perceptions Questionnaire (T-TPQ)"	24 hours
Parental experience of the procedure		24 hours
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Liege

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: premature birth; golden hour; 60 minutes
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: GOLDEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No