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

• Sponsor: Centre Hospitalier Universitaire de Liege (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05175911
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 16.7
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Other: golden hour : an initial standardized stabilization

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 10, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Completion of the procedure : closing time of the incubator [1 hour]

   Number of minutes of life at incubator closure

2. 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

3. Thermal stability : temperature at admission and at the end of the procedure [1 hour]

4. Mortality rate [3 months]

Secondary Outcome Measures

1. Process of the procedure: [1 hour]

   Number of minutes of life at initiation of parenteral nutrition, caffeine and antibiotics administration.

2. Incidence of hypotension and bradycardia [1 hour]

3. Intubation rate and duration of mechanical ventilation [3 months]

   Number of hours of mechanical ventilation

4. Need for surfactant administration and time of administration [3 days]

   Number of hours of life at surfactant administration

5. Comorbidities of prematurity: NEC, BPD, ROP, sepsis, PDA, cPVL, IVH [3 months]

6. Duration of hospital stay (only if no transfer) [3 months]

7. Caregiver's perception of the procedure: stress… [24 hours]

   use of a questionnaire adapted from the "Teamwork Perceptions Questionnaire (T-TPQ)"

8. Parental experience of the procedure [24 hours]

9. 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,...

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Hour
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Liège	Liège		Belgium	4000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tribolet Sophie, Doctor, Centre Hospitalier Universitaire de Liege
• ClinicalTrials.gov Identifier: NCT05175911
• Other Study ID Numbers: Golden
• First Posted: Jan 4, 2022
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tribolet Sophie, Doctor, Centre Hospitalier Universitaire de Liege: premature birth; golden hour; 60 minutes
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Mar 9, 2022