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 (GOLD)

March 6, 2026 updated by: Centre Hospitalier Universitaire de Nice

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Premature newborns born before 28 weeks of amenorrhea (SA) or with very low birth weight (<1000g)

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Antenatal pathology involving a limitation of active therapies decided before birth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-PP-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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