REspiratory MEchanics for Delivering Individualised Exogenous Surfactant

NCT ID: NCT05791331

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2025-12-31

Brief Summary

This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are:

1. to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and

2. to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%.

Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center.

Study Arms:

A) Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).

Conditions

Respiratory Distress Syndrome in Premature Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A/Control

Surfactant administration following clinical assessment

Group Type: ACTIVE_COMPARATOR

Surfactant administration following clinical assessment

Intervention Type: OTHER

Surfactant is administered following oxygenation-based criteria

B/Intervention

Surfactant administration following both lung mechanics assessment and clinical assessment

Group Type: EXPERIMENTAL

Surfactant administration following lung mechanics assessment in addition to clinical assessment

Intervention Type: OTHER

Surfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O\*s /L

Interventions

Surfactant administration following lung mechanics assessment in addition to clinical assessment

Surfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O\*s /L

Intervention Type: OTHER

Surfactant administration following clinical assessment

Surfactant is administered following oxygenation-based criteria

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Gestational age (GA) ≥ 27+0 and < 33+0 weeks

2. Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 >0.30 for target SpO2 88-93% or Silverman score ≥ 5.

3. Inborn

4. Written parental consent obtained

5. Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care

Exclusion Criteria

1. Major congenital anomalies

2. Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).

3. Surfactant therapy prior to the study entry

4. Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH < 7.0 or base excess (BE) < -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy

5. Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations…)

6. Any clinical condition which may place the infants at undue risk as deemed by clinicians

7. Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study

8. Outborn patients

• Minimum Eligible Age: 27 Weeks
• Maximum Eligible Age: 33 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Politecnico di Milano

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Anna Lavizzari

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Studio Numero 6379

Identifier Type: OTHER

Identifier Source: secondary_id

Sperimentazione 3115

Identifier Type: -

Identifier Source: org_study_id