Newborn ComplicationGOLDNCT07461623
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
An observational study of Newborn Complication and Premature, run by Centre Hospitalier Universitaire de Nice.
Trial summary
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb. This critical period is marked by major physiological instability, particularly among the most immature newborns, i.e., extremely premature infants born before 28 weeks of… Read more about this study
- Who is it for?
- Ages 20 to 28 weeks
- Conditions the study is for
- Newborn Complication, Premature
- What is being tested?
- Golden Hour protocol
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2027
- 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 20 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature newborns born before 28 weeks of amenorrhea (SA) or with very low birth weight (<1000g)
Who may be able to join
- All newborns < 28 weeks gestation and/or < 1000g born at Nice University Hospital.
- Affiliated with French social security;
- After obtaining the consent of one of the parents or the representative of parental authority.
Who cannot join
- Antenatal pathology involving a limitation of active therapies decided before birth.
About this study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb. This critical period is marked by major physiological instability, particularly among the most immature newborns, i.e., extremely premature infants born before 28 weeks of amenorrhea (SA) or with very low birth weight (<1000g), exposing them to acute complications such as hypothermia, hypoglycemia, severe respiratory distress, or hemodynamic instability. All these factors are known to be associated with the prognosis in terms of neonatal morbidity and mortality.
Improving care during the first hour of life-often referred to as the "golden hour"-is crucial for stabilizing these vulnerable newborns. The implementation of a medical and nursing protocol that anticipates and carries out the necessary procedures for these newborns could therefore be a lever for improvement. However, this change in practice is dependent on material conditions, team organization, and the individual needs of the newborn and their family, all of which are variables that can limit or hinder the implementation of what is considered optimal care.
It is therefore necessary to assess both the practical feasibility of such a stabilization protocol during the golden hour and the potential modifiable factors associated with implementation difficulties in order to identify any obstacles, particularly systemic ones. Finally, the association between this change in practice and the prognosis of the premature newborns to whom it is applied should be studied.
- Conditions
- Newborn Complication, Premature
- Being tested
- Golden Hour protocol
- Keywords
- premature, Newborn Complication
- 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 protocolProcedure or surgery
Stabilization of the premature newborn within 60 minutes or less. Stabilization of the newborn will be defined by: access established and functional, parenteral nutrition initiated, treatments administered, and respiratory stability allowing the incubator doors to be closed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the golden hour protocol
Evaluate the success of implementing the Golden Hour protocol, defined as the time between birth and stabilization in less than or equal to 60 minutes, allowing for the stabilization of the premature newborn.
The stabilization of the newborn will be defined by: an established and functional access route, parenteral nutrition initiated, treatments administered, and respiratory stability allowing the incubator doors to be closed.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Why it stopped: unfavorable opinion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn ComplicationStudies 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
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461623
- Sponsor's protocol ID
- 25-PP-20
- Acronym
- GOLD
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
- ClinicalTrials.gov ID
- NCT07461623
- Acronym / sponsor ID
- GOLD / 25-PP-20
- Conditions
- Newborn Complication, Premature
- Keywords
- premature, Newborn Complication
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: unfavorable opinion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb. This critical period is marked by major physiological instability, particularly among the most immature newborns, i.e., extremely premature infants born before 28 weeks of amenorrhea (SA) or with very low birth weight (<1000g), exposing them to acute complications such as hypothermia, hypoglycemia, severe respiratory distress, or hemodynamic instability. All these factors are known to be associated with the prognosis in terms of neonatal morbidity and mortality.
Improving care during the first hour of life-often referred to as the "golden hour"-is crucial for stabilizing these vulnerable newborns. The implementation of a medical and nursing protocol that anticipates and carries out the necessary procedures for these newborns could therefore be a lever for improvement. However, this change in practice is dependent on material conditions, team organization, and the individual needs of the newborn and their family, all of which are variables that can limit or hinder the implementation of what is considered optimal care.
It is therefore necessary to assess both the practical feasibility of such a stabilization protocol during the golden hour and the potential modifiable factors associated with implementation difficulties in order to identify any obstacles, particularly systemic ones. Finally, the association between this change in practice and the prognosis of the premature newborns to whom it is applied should be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature newborns born before 28 weeks of amenorrhea (SA) or with very low birth weight (<1000g)
Key inclusion criteria (3 listed)
- All newborns < 28 weeks gestation and/or < 1000g born at Nice University Hospital.
- Affiliated with French social security;
- After obtaining the consent of one of the parents or the representative of parental authority.
Key exclusion criteria (1 listed)
- Antenatal pathology involving a limitation of active therapies decided before birth.
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 protocolStabilization of the premature newborn within 60 minutes or less. Stabilization of the newborn will be defined by: access established and functional, parenteral nutrition initiated, treatments administered, and respiratory stability allowing the incubator doors to be closed. | Procedure or surgery | – |
Primary outcome
Success of the golden hour protocol
Time frame: 60 minutes
Evaluate the success of implementing the Golden Hour protocol, defined as the time between birth and stabilization in less than or equal to 60 minutes, allowing for the stabilization of the premature newborn. The stabilization of the newborn will be defined by: an established and functional access route, parenteral nutrition initiated, treatments administered, and respiratory stability allowing the incubator doors to be closed.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Newborn Complication
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Active, not recruitingPhase 2
A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
Alport Syndrome
RecruitingObservational study
Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Complication and Premature, run by Centre Hospitalier Universitaire de Nice.
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 1 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: withdrawn, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the golden hour protocol (time frame: 60 minutes). 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 10 Mar 2026.