Premature BirthNCT05175911
Implementation of the Golden Hour for Preterm Infants : a Quality Improvement Study
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 1 hour
- Conditions the study is for
- Premature Birth
- What is being tested?
- golden hour : an initial standardized stabilization
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jan 2022to 1 Jun 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 hour
- All sexes
- No healthy volunteers
- Child
Study population: Premature younger than 31 weeks of gestational age or less than 1300 g expected
Who may be able to join
- Premature infants (< 31 weeks' gestation)
- Infants with expected weight less than 1300 g
- Inborn babies
Who cannot join
- Infants outborn
- Infants with major congenital anomalies (laparoschisis, omphalocèle, diaphragmatic hernia, …)
- Parental refusal
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Liège
Liège, 4000
Sophie Tribolet, sophie.tribolet@chuliege.be
About this study
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
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.
- Conditions
- Premature Birth
- Being tested
- golden hour : an initial standardized stabilization
- Keywords
- premature birth, golden hour, 60 minutes
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
golden hour : an initial standardized stabilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| premature infants | premature infants less than 31 weeks of gestation or weighting less than 1300 g Receives: Other: golden hour : an initial standardized stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the procedure : closing time of the incubator
Number of minutes of life at incubator closure
Measured: 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
Measured: 24 hours
Thermal stability : temperature at admission and at the end of the procedure
Measured: 1 hour
Mortality rate
Measured: 3 months
Secondary outcomes (9)
Process of the procedure:
Number of minutes of life at initiation of parenteral nutrition, caffeine and antibiotics administration.
Measured: 1 hour
Incidence of hypotension and bradycardia
Measured: 1 hour
Intubation rate and duration of mechanical ventilation
Number of hours of mechanical ventilation
Measured: 3 months
Need for surfactant administration and time of administration
Number of hours of life at surfactant administration
Measured: 3 days
Comorbidities of prematurity: NEC, BPD, ROP, sepsis, PDA, cPVL, IVH
Measured: 3 months
Duration of hospital stay (only if no transfer)
Measured: 3 months
Caregiver's perception of the procedure: stress…
use of a questionnaire adapted from the "Teamwork Perceptions Questionnaire (T-TPQ)"
Measured: 24 hours
Parental experience of the procedure
Measured: 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,...
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start10 Jan 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tribolet Sophie, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175911
- Sponsor's protocol ID
- Golden
- Status last verified
- Mar 2022
- First submitted
- 1 Dec 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05175911
- Acronym / sponsor ID
- Golden
- Conditions
- Premature Birth
- Keywords
- premature birth, golden hour, 60 minutes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature infants | – | Other: golden hour : an initial standardized stabilizationpremature infants less than 31 weeks of gestation or weighting less than 1300 g |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature younger than 31 weeks of gestational age or less than 1300 g expected
Key inclusion criteria (3 listed)
- Premature infants (< 31 weeks' gestation)
- Infants with expected weight less than 1300 g
- Inborn babies
Key exclusion criteria (3 listed)
- Infants outborn
- Infants with major congenital anomalies (laparoschisis, omphalocèle, diaphragmatic hernia, …)
- Parental refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| golden hour : an initial standardized stabilizationThis 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. | Other | premature infants |
Primary outcome
Completion of the procedure : closing time of the incubator
Time frame: 1 hour
Number of minutes of life at incubator closure
Glycemia at admission and within 24 hours
Time frame: 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
Time frame: 1 hour
Mortality rate
Time frame: 3 months
9 secondary outcomes
Process of the procedure:
Time frame: 1 hour
Incidence of hypotension and bradycardia
Time frame: 1 hour
Intubation rate and duration of mechanical ventilation
Time frame: 3 months
Need for surfactant administration and time of administration
Time frame: 3 days
Comorbidities of prematurity: NEC, BPD, ROP, sepsis, PDA, cPVL, IVH
Time frame: 3 months
Duration of hospital stay (only if no transfer)
Time frame: 3 months
Caregiver's perception of the procedure: stress…
Time frame: 24 hours
Parental experience of the procedure
Time frame: 24 hours
Conditions of the procedure : realization during the night shift and team composition
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Tribolet (003243215648, sophie.tribolet@chuliege.Be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of the procedure : closing time of the incubator (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.