Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)

NCT05248477 | Active Not Recruiting

• 2 other identifiers: APHP2110042021-A02520-41
• Study Type: interventional
• Target: 2,377
• Locations: 1 country
• Sites: 1

Brief Summary

The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery. Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery. The follow-up collected for this study will take place:

• At D4 post-delivery: A questionnaire about the parents' experience of the information delivered and the decisions made will be given to and collected from the parents
• At Day 28, post-delivery: A questionnaire about the parents' experience of care for their child will be given to and collected from the mother and the co-parent.
• At the child's discharge from the hospital, or if he or she dies in the hospital:
• Collection of clinical data (principal endpoint) from data in the medical file.
• Data to measure practices and adherence to the intervention will be collected
• When the child reaches the corrected age of 2 years:
• a short questionnaire will be completed by the physician caring for the child at the corrected age of 2 years. The data collected will concern motor and sensory development, in particular, cerebral palsy, blindness, and deafness..
• Information about the child's development will also be collected with a questionnaire including a standardized assessment scale, he PARCA-R questionnaire (Parent Report of Children's Abilities-Revides), which the parents will complete.

Conditions

Newborn; Extreme Prematurity; Pretrm Infants

Keywords

extremely preterm infants; periviable birth; perinatal management; EXPRIM protocol

Outcome Measures

Primary Outcomes (1)

• survival at hospital discharge without severe morbidity (composite outcome)

  Severe morbidity is a composite criterion assessed up to 40 post-menstrual age (PMA) and defined by at least one of the following severe neonatal morbidities: * Severe bronchopulmonary dysplasia, defined by the need for oxygen therapy and/or mechanical ventilatory support (endotracheal or noninvasive) at 36 weeks PMA (Jobe 2001). * Severe intraventricular hemorrhage (IVH), defined by IVH of either grade 3, associated with ventricular dilation, or grade 4, which is associated with a hemorrhagic lesion of the adjacent parenchyma) (Volpe 2009). * Severe retinopathy, defined as retinopathy of prematurity (ROP) of type 3 or higher according to the international classification (ICCROP 2005) and/or need for laser treatment. * Severe enterocolitis, defined as types 2 and 3 in the modified Bell's classification (Bell, 1978). * Periventricular leukomalacia, defined by cavities in the periventricular white matter on ultrasound.

  Up to 24 Weeks

Secondary Outcomes (6)

• Child's survival at hospital discharge

  Up to 24 Weeks

• Neurosensory condition ( composite outcome)

  at a corrected age of 2 years.

• child's global development

  at a corrected age of 2 years.

• Medical economics:

  at a corrected age of 2 years

• Parents' experience of the information they received, their involvement in decision making, and the decisions made

  on day 4

Study Arms (2)

usual practice

NO INTERVENTION

Premex protocol

EXPERIMENTAL

a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children

Other: Premex Protocol

Interventions

Premex Protocol OTHER

This protocol presupposes stages during which staff are informed and trained. It is based on the following principles: * Administration of corticosteroid therapy to all eligible women, independent of the decision about active or palliative care * A prognostic evaluation in a non-emergency meeting of the obstetricians and neonatologists/pediatricians involved, no longer based only on gestational age, and enabling the team to provide consistent, consensual, and individualized information to parents; * A joint decision about the obstetric and neonatal (active or palliative) care to be proposed to parents at the end of this evaluation; * An interview with parents, also on non-emergency basis, to give them information about the child's prognosis and the management proposed, to answer their questions, and to obtain their opinion; * Management at birth consistent with that decided in consultation with the parents.

Premex protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers:
• women hospitalized between 22 and 26 weeks for risk of preterm delivery with a fetus alive or dead at admission and with a delivery between 22 and 26 completed weeks
• understanding of the French language by the woman or in the immediate entourage in charge of the child.
• Children: all newborns (live- and stillborn) delivered between 22 and 26 weeks.

You may not qualify if:

• women who object to the use of their routine perinatal data,
• women giving birth before 22 weeks and after 26 completed weeks.
• woman to legal protection (subject protected by law under guardianship or curatorship)
• Women undergoing a termination of pregnancy (TOP) for severe congenital anomaly or psycho-social contexte

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (1)

• Lamau MC, Ruiz E, Merrer J, Sibiude J, Huon C, Lepercq J, Goffinet F, Jarreau PH. A new individualized prognostic approach to the management of women at risk of extreme preterm birth in France: Effect on neonatal outcome. Arch Pediatr. 2021 Jul;28(5):366-373. doi: 10.1016/j.arcped.2021.04.005. Epub 2021 May 28.

  PMID: 34059380 BACKGROUND

Study Officials

• Pierre-Henri JARREAU, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Pierre-Yves ANCEL, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 21, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)