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NCT Number: NCT07829562

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

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.

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Key information

Conditions

Prematurity; Extreme Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

23 week–27 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Mritimes, 06200, France

Location contact

Bérengère FRANCOIS-GARRET, MD

CONTACT

[email protected]

4 92 03 63 65 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Golden Hour protocol

    Time frame: 12 months

    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.

Secondary outcomes

  1. Neonatal individual factors associated with treatment failure

    Time frame: 12 months

    Compilation of individual neonatal factors (gestational age, birth weight, time from birth to care, circumstances of birth, care in the delivery room).

  2. Organizational factors related to childbirth associated with protocol failure

    Time frame: 12 months

    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)

  3. Acceptance of the protocol by the teams

    Time frame: 12 months

    Satisfaction survey completed by the external evaluator, the physician, and the nurse in charge of the patient.

  4. Effectiveness of the Golden Hour protocol at one hour of life

    Time frame: 12 months

    Recording of temperature (in celsius degrees) at 1 hour of life in accordance with the department's current protocol.

  5. Effectiveness of the Golden Hour protocol at two hours of life

    Time frame: 12 months

    Recording of blood glucose (in g/L) at 2 hours of life in accordance with the department's current protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Bérengère FRANCOIS-GARRET, MD

CONTACT

[email protected]

492036365 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Acronym: PREM-GH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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