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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

Study acronym: PREM-GH
StatusNot Yet Recruiting
PhaseNot applicable
Started2026-10
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07829562
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Prematurity; Extreme
Enrollment 50 participants
Start Date 2026-10
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-21