Personalized surfactant delivery using lung mechanics in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial compares surfactant given based on lung mechanics assessments to standard surfactant administration in preterm infants born between 27+0 and 32+6 weeks who require non-invasive respiratory support. Non-invasive support is delivered with nasal CPAP and FiO2 adjusted to maintain SpO2 91-95%. The primary goal is to see if the lung-mechanics–guided approach reduces the duration of respiratory support by about five days, with secondary goals including timing of treatment and broader neonatal outcomes. Infants are randomized after consent under applicable data protection regulations, with non-pharmacological intervention and standard clinical care.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione IRCCs Cà Granda Ospedale Maggiore Policlinico
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Anna Lavizzari, MD
• Email: anna.lavizzari@gmail.com
• Phone: 0039 3208715095

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surfactant delivery methods in preterm infants with RDS in Sweden

  This study tests different ways of giving surfactant to preterm babies with respiratory distress to see which method works best when care is routine.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07550218

• Lung ultrasound score to guide surfactant timing in preterm newborns

  This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.

  Recruiting Hackensack Meridian Health · Hackensack, New Jersey · NCT07442669

• Predicting which newborns in a lower-level NICU will need extended breathing support

  This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07344714

• Optimising breathing support at extubation for very preterm infants

  This trial will try starting nasal CPAP before removing the breathing tube versus starting it after extubation to see if that reduces oxygen drops in very preterm infants.

  Recruiting at 3 sites Murdoch Childrens Research Institute · Melbourne, Victoria and 2 other locations · NCT07251790

• Surfactant given through a laryngeal mask for preterm babies with RDS in Vietnam

  For preterm babies under 34 weeks with respiratory distress, the team will try giving surfactant through a soft throat mask (SALSA) instead of an endotracheal tube (INSURE) to see if it reduces the need for invasive breathing support.

  Recruiting Karolinska Institutet · Hanoi · NCT07098910

• Giving surfactant to premature infants using a thin catheter at birth

  This study is testing if giving a special lung treatment to very premature babies right after birth using a thin tube can help them breathe better and need less breathing support in their first few days of life.

  Recruiting University College Dublin · Dublin, None Selected · NCT06557551

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.