Prematurity; ExtremePREM-GHNCT07829562
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
A study testing Golden hour in people with Prematurity; Extreme, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Preterm infants 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 significant physiological instability, particularly among the most immature newborns-that is, extremely preterm infants born before 28 weeks of… Read more about this study
- Who is it for?
- Ages 23 to 27 weeks
- Conditions the study is for
- Prematurity; Extreme
- What is being tested?
- Golden hour
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 23 to 27 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns at 23-27 weeks' gestation + 6 days (< 28 weeks' gestation) and/or with a birth weight between 450 g and 999 g (< 1,000 g) born at the Nice University Hospital; (weight estimated prenatally and confirmed at birth) To implement the protocol for newborns weighing < 1,000 g, the weight used is that estimated by an ultrasound performed before birth.
- Enrolled in the insurance ;
- After obtaining consent from the parents or the legal guardian.
- All eligible patients during the study period will be included consecutively
Who cannot join
- Prenatal condition requiring a decision made before birth to limit active treatment (severe genetic abnormality [e.g., trisomy 18], need for extensive medical and/or surgical care that is not compatible with delivery at extreme term [e.g., esophageal atresia with delivery at 24 weeks' gestation]). Decision made before birth by the obstetric-pediatric team;
- A newborn with a confirmed birth weight of more than 1,000 grams.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Mritimes, 06200
Bérengère FRANCOIS-GARRET, MD, 4 92 03 63 65 ext. +33, francois-garret.b@chu-nice.fr
About this study
Official title: A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns - PREM-GH
Preterm infants 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 significant physiological instability, particularly among the most immature newborns-that is, extremely preterm infants born before 28 weeks of gestation (WG) or with very low birth weight (<1000 g)- exposing them to acute complications such as hypothermia, hypoglycemia, severe respiratory distress, or hemodynamic instability. All these factors are known to be associated with neonatal morbidity and mortality.
Improving care during the first hour of life-often referred to as the "golden hour"-is critical to stabilizing these vulnerable newborns. Therefore, implementing a medical and nursing protocol that enables the anticipation and execution of the necessary interventions for these newborns is a key driver of improvement. To this end, since March 2025, we have implemented a protocol to optimize care during the first hour of life for extremely preterm and very low birth weight newborns. However, this change in practice is influenced by material conditions, team organization, and the individual needs of the newborn and their family, and involves multiple variables that may limit or hinder the implementation of care considered optimal.
Thus, it is necessary to assess the potential modifiable factors associated with difficulties in implementing care during the first hour of life.
- Conditions
- Prematurity; Extreme
- Being tested
- Golden hour
- Keywords
- Prematurity; Extreme
- 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 hourProcedure or surgery
Feasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth.
The entire packaging process of the newborn will be determined by: an established and functional access route, initiation of parenteral nutrition, administration of treatments, and respiratory stability sufficient to allow the incubator doors to be closed.
| Study group | Role | What they receive |
|---|---|---|
| Golden hour protocol | Other | Feasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth Receives: Procedure: Golden hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Golden Hour protocol
To assess compliance with the "Golden Hour" protocol's target timeframe, defined as achieving full stabilization of the preterm newborn within the first 60 minutes of life.
Measured: 12 months
Secondary outcomes (5)
Neonatal individual factors associated with treatment failure
Compilation of individual neonatal factors (gestational age, birth weight, time from birth to care, circumstances of birth, care in the delivery room).
Measured: 12 months
Organizational factors related to childbirth associated with protocol failure
Compilation of organizational factors related to childbirth (experience of the medical and paramedical staff, the team's workload at the time of delivery, and whether the birth occurred during an on-call shift)
Measured: 12 months
Acceptance of the protocol by the teams
Satisfaction survey completed by the external evaluator, the physician, and the nurse in charge of the patient.
Measured: 12 months
Effectiveness of the Golden Hour protocol at one hour of life
Recording of temperature (in celsius degrees) at 1 hour of life in accordance with the department's current protocol.
Measured: 12 months
Effectiveness of the Golden Hour protocol at two hours of life
Recording of blood glucose (in g/L) at 2 hours of life in accordance with the department's current protocol.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity; ExtremeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- NCT07829562
- Sponsor's protocol ID
- 26-PP-02
- Acronym
- PREM-GH
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns - PREM-GH
- ClinicalTrials.gov ID
- NCT07829562
- Acronym / sponsor ID
- PREM-GH / 26-PP-02
- Conditions
- Prematurity; Extreme
- Keywords
- Prematurity; Extreme
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Sep 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.
Preterm infants 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 significant physiological instability, particularly among the most immature newborns-that is, extremely preterm infants born before 28 weeks of gestation (WG) or with very low birth weight (<1000 g)- exposing them to acute complications such as hypothermia, hypoglycemia, severe respiratory distress, or hemodynamic instability. All these factors are known to be associated with neonatal morbidity and mortality.
Improving care during the first hour of life-often referred to as the "golden hour"-is critical to stabilizing these vulnerable newborns. Therefore, implementing a medical and nursing protocol that enables the anticipation and execution of the necessary interventions for these newborns is a key driver of improvement. To this end, since March 2025, we have implemented a protocol to optimize care during the first hour of life for extremely preterm and very low birth weight newborns. However, this change in practice is influenced by material conditions, team organization, and the individual needs of the newborn and their family, and involves multiple variables that may limit or hinder the implementation of care considered optimal.
Thus, it is necessary to assess the potential modifiable factors associated with difficulties in implementing care during the first hour of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golden hour protocol | Other | Procedure: Golden hourFeasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth |
Who may qualify
- Ages
- 23 to 27 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborns at 23-27 weeks' gestation + 6 days (< 28 weeks' gestation) and/or with a birth weight between 450 g and 999 g (< 1,000 g) born at the Nice University Hospital; (weight estimated prenatally and confirmed at birth) To implement the protocol for newborns weighing < 1,000 g, the weight used is that estimated by an ultrasound performed before birth.
- Enrolled in the insurance ;
- After obtaining consent from the parents or the legal guardian.
- All eligible patients during the study period will be included consecutively
Key exclusion criteria (2 listed)
- Prenatal condition requiring a decision made before birth to limit active treatment (severe genetic abnormality [e.g., trisomy 18], need for extensive medical and/or surgical care that is not compatible with delivery at extreme term [e.g., esophageal atresia with delivery at 24 weeks' gestation]). Decision made before birth by the obstetric-pediatric team;
- A newborn with a confirmed birth weight of more than 1,000 grams.
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 hourFeasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth. The entire packaging process of the newborn will be determined by: an established and functional access route, initiation of parenteral nutrition, administration of treatments, and respiratory stability sufficient to allow the incubator doors to be closed. | Procedure or surgery | Golden hour protocol |
Primary outcome
Golden Hour protocol
Time frame: 12 months
To assess compliance with the "Golden Hour" protocol's target timeframe, defined as achieving full stabilization of the preterm newborn within the first 60 minutes of life.
5 secondary outcomes
Neonatal individual factors associated with treatment failure
Time frame: 12 months
Organizational factors related to childbirth associated with protocol failure
Time frame: 12 months
Acceptance of the protocol by the teams
Time frame: 12 months
Effectiveness of the Golden Hour protocol at one hour of life
Time frame: 12 months
Effectiveness of the Golden Hour protocol at two hours of life
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Golden hour in people with Prematurity; Extreme, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Sep 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bérengère FRANCOIS-GARRET, MD (492036365 ext. +33, francois-garret.b@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Golden Hour protocol (time frame: 12 months). 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 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.