REspiratory MEchanics for Delivering Individualised Exogenous Surfactant

Respiratory Distress Syndrome in Premature Infant Clinical Trial

— REMEDIES  

Official title:

A Randomized Controlled Trial of Oscillatory Mechanics Versus Oxygenation-based Criteria for Surfactant Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05791331
• Other study ID #: Sperimentazione 3115
• Secondary ID: Studio Numero 63
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 458
• Est. completion date: December 31, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• 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
• Surfactant administration following clinical assessment
Surfactant is administered following oxygenation-based criteria

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Politecnico di Milano

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First surfactant administration	Time of first surfactant administration (in hours)	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	Days of non-invasive respiratory support	Number of 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"
Secondary	Days of invasive respiratory support	Number of 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"
Secondary	Patients intubated and mechanically ventilated	Number of 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"
Secondary	Patients receiving multiple surfactant doses	Number of 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"
Secondary	Days on supplemental oxygen	Number of days on supplemental oxygen	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	Total cumulative oxygen exposure	Total cumulative oxygen exposure computed as the time integral of the FiO2 values	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	Infants receiving more than 28 days of respiratory support	Number of infants receiving more than 28 days of 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	Infants developing BPD	Number of infants developing BPD according to the definition by NICHD 2016	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	Infants developing air-leaks	Number of infants developing air-leaks	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	Infants developing prematurity-associated complications	Number of infants developing prematurity-associated complications (severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), patent ductus arteriosus requiring pharmacological or surgical treatment)	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	Infants discharged home with oxygen or respiratory support	Number of infants discharged home with oxygen or 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	Days to achieve full-enteral feeding	Number of days to achieve full-enteral feeding (160 ml/kg/day of milk intake)	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	Days of hospitalization	Number of days of hospitalization	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	Infants receiving postnatal steroids	Number of infants receiving postnatal steroids	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"