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NOT YET RECRUITING
NCT07829562
NA

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

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

23 Weeks - 27 Weeks

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-10

Completion Date

2027-10

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

PROCEDURE

Golden hour

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.

Locations (1)

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Mritimes, France