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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
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
Conditions
Interventions
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