NCT07461623

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 20 Weeks – 28 Weeks
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
PROCEDURE	Golden Hour protocol	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-03-10
• Last updated: 2026-03-10