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

NCT07461623 | Withdrawn

• 1 other identifier: 25-PP-20
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

premature; Newborn Complication

Outcome Measures

Primary Outcomes (1)

• 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.

  60 minutes

Interventions

Golden Hour protocol PROCEDURE

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.

Eligibility Criteria

• Age: 20 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03