REspiratory MEchanics for Delivering Individualised Exogenous Surfactant

NCT05791331 | Unknown DMC

• 2 other identifiers: Sperimentazione 3115Studio Numero 6379
• Study Type: interventional
• Target: 458
• Locations: 0 countries
• Sites: N/A

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. 1.to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and
2. 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%.

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

Surfactant; Respiratory mechanics; Respiratory Oscillometry; Forced Oscillation technique; Neonatal RDS; CPAP; CPAP failure; Premature infant

Outcome Measures

Primary Outcomes (1)

• Days of respiratory support

  Number of days of required respiratory support

  From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Secondary Outcomes (15)

• First surfactant administration

  From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

• Days of non-invasive respiratory support

  From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

• Days of invasive respiratory support

  From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

• Patients intubated and mechanically ventilated

  From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

• Patients receiving multiple surfactant doses

  From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"

Study Arms (2)

A/Control

ACTIVE COMPARATOR

Surfactant administration following clinical assessment

Other: Surfactant administration following clinical assessment

B/Intervention

EXPERIMENTAL

Surfactant administration following both lung mechanics assessment and clinical assessment

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

Interventions

Surfactant administration following lung mechanics assessment in addition to clinical assessment OTHER

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

B/Intervention

Surfactant administration following clinical assessment OTHER

Surfactant is administered following oxygenation-based criteria

A/Control

Eligibility Criteria

• Age: 27 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• Politecnico di Milano: collaborator

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: March 30, 2023
• Study Start: May 18, 2023
• Primary Completion: May 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 30, 2023

Record last verified: 2023-03