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

NCT07829562 | Not Yet Recruiting

• 1 other identifier: 26-PP-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity; Extreme

Keywords

Prematurity; Extreme

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Neonatal individual factors associated with treatment failure

  12 months

• Organizational factors related to childbirth associated with protocol failure

  12 months

• Acceptance of the protocol by the teams

  12 months

• Effectiveness of the Golden Hour protocol at one hour of life

  12 months

• Effectiveness of the Golden Hour protocol at two hours of life

  12 months

Study Arms (1)

Golden hour protocol

OTHER

Feasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth

Procedure: Golden hour

Interventions

Golden hour PROCEDURE

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.

Golden hour protocol

Eligibility Criteria

• Age: 23 Weeks - 27 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Mritimes, 06200, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Bérengère FRANCOIS-GARRET, MD

CONTACT

492036365; francois-garret.b@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)