Comparing non-pharmacological and analgesic approaches for surfactant treatment in premature 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

The NONA-LISA trial is a multicentre, pragmatic, parallel-group, blinded randomized controlled trial conducted at four university hospitals in Denmark. It aims to compare the effectiveness of Less Invasive Surfactant Administration (LISA) using a non-pharmacological approach versus LISA combined with routine analgesic treatment in premature infants born between 24 and 29 weeks of gestation. A total of 324 infants will be enrolled over 36 months, with the primary outcome being the rate of LISA failure, defined as the need for positive pressure ventilation within 24 hours after the procedure. The study seeks to determine if avoiding pre-procedure analgesia can improve outcomes for these vulnerable infants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Infants born at one of the trial sites with a gestational age of 24+0 to 29+6 weeks and meeting the criteria for first-choice surfactant treatment by LISA as described by Sweet et al.: worsening babies with RDS and FiO2 \> 0.30 on CPAP pressure ≥6 cm H2O.

Exclusion Criteria:

1. suspicion of lung hypoplasia,
2. endotracheal intubation at any time before randomisation,
3. suspicion of pneumothorax, pulmonary haemorrhage or pleural effusion before LISA,
4. major congenital anatomical anomalies as described by the European Surveillance of Congenital Anomalies (EUROCAT).

Where it's running

• Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit
  Aarhus, Denmark Recruiting
• Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9
  Copenhagen, Denmark Recruiting
• Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15
  Aalborg, Denmark Withdrawn
• H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 60
  Odense, Denmark Not yet recruiting

Study contacts

• Principal investigator: Niklas Breindahl, MD — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Lise Aunsholt, MD, PhD
• Email: lise.aunsholt@regionh.dk
• Phone: +4561991137

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.