REspiratory MEchanics for Delivering Individualised Exogenous Surfactant (REMEDIES)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

Respiratory Distress Syndrome in Premature Infant

Treatments

Other: Surfactant administration following lung mechanics assessment in addition to clinical assessment

Other: Surfactant administration following clinical assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT05791331

Sperimentazione 3115

Studio Numero 6379 (Other Identifier)

Details and patient eligibility

About

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:

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

Enrollment

458 estimated patients

Sex

All

Ages

27 to 33 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

Gestational age (GA) ≥ 27+0 and < 33+0 weeks
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.
Inborn
Written parental consent obtained
Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care

Exclusion criteria

Major congenital anomalies
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).
Surfactant therapy prior to the study entry
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
Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations...)
Any clinical condition which may place the infants at undue risk as deemed by clinicians
Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study
Outborn patients