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)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prematurity; Extreme
• Intervention / Treatment: Procedure: Golden hour

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bérengère FRANCOIS-GARRET, MD; Phone Number: +33 492036365; Email: francois-garret.b@chu-nice.fr

Study Locations

• France
  • Alpes-Mritimes
    • Nice, Alpes-Mritimes, France, 06200
      • CHU Nice - Hôpital de l'Archet 2
      • Contact: Bérengère FRANCOIS-GARRET, MD; Phone Number: +33 4 92 03 63 65; Email: francois-garret.b@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Newborns at 23-27 weeks' gestation + 6 days (< 28 weeks' gestation) and/or with a birth weight between 450 g and 999 g (< 1,000 g) born at the Nice University Hospital; (weight estimated prenatally and confirmed at birth) To implement the protocol for newborns weighing < 1,000 g, the weight used is that estimated by an ultrasound performed before birth.
• Enrolled in the insurance ;
• After obtaining consent from the parents or the legal guardian.
• All eligible patients during the study period will be included consecutively

Exclusion Criteria:

• Prenatal condition requiring a decision made before birth to limit active treatment (severe genetic abnormality [e.g., trisomy 18], need for extensive medical and/or surgical care that is not compatible with delivery at extreme term [e.g., esophageal atresia with delivery at 24 weeks' gestation]). Decision made before birth by the obstetric-pediatric team;
• A newborn with a confirmed birth weight of more than 1,000 grams.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Golden hour protocol; Feasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Golden Hour protocol	To assess compliance with the "Golden Hour" protocol's target timeframe, defined as achieving full stabilization of the preterm newborn within the first 60 minutes of life.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal individual factors associated with treatment failure	Compilation of individual neonatal factors (gestational age, birth weight, time from birth to care, circumstances of birth, care in the delivery room).	12 months
Organizational factors related to childbirth associated with protocol failure	Compilation of organizational factors related to childbirth (experience of the medical and paramedical staff, the team's workload at the time of delivery, and whether the birth occurred during an on-call shift)	12 months
Acceptance of the protocol by the teams	Satisfaction survey completed by the external evaluator, the physician, and the nurse in charge of the patient.	12 months
Effectiveness of the Golden Hour protocol at one hour of life	Recording of temperature (in celsius degrees) at 1 hour of life in accordance with the department's current protocol.	12 months
Effectiveness of the Golden Hour protocol at two hours of life	Recording of blood glucose (in g/L) at 2 hours of life in accordance with the department's current protocol.	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Prematurity; Extreme
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 26-PP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No