The first 60 minutes: can a golden hour protocol stabilize the tiniest newborns?

NCT ID NCT07829562

NEW Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Nice Source: ClinicalTrials.gov ↗

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Extremely preterm and very low birth weight newborns face serious risks in their first hour of life, including hypothermia, low blood sugar, breathing problems, and unstable circulation. Researchers at Nice University Hospital are studying a Golden Hour protocol that aims to stabilize these newborns within 60 minutes of birth. The study looks at which factors, such as the baby's condition, the delivery circumstances, and how the care team is organized, are linked to whether the protocol is completed on time. About 50 newborns born before 28 weeks of gestation or weighing under 1,000 grams take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Golden Hour protocol, a structured set of medical and nursing steps to stabilize a preterm newborn within the first hour of life
What this could lead to: If researchers identify which factors help or hinder the protocol, hospitals could refine how they organize care in the first hour of life for the most fragile newborns.
What could go wrong: This is a small observational study at a single hospital, so its findings may not apply to other units with different staffing, equipment, or patient populations. It measures how the protocol is carried out, not whether it saves lives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

23 to 27 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prematurity; extreme

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

The first 60 minutes: can a golden hour protocol stabilize the tiniest newborns?

What the study statuses mean