Surfactant Deficiency Syndrome Neonatal

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Review clinical trials related to Surfactant Deficiency Syndrome Neonatal. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration

Many preterm babies born between 22-28+6 weeks' estimated gestational age (EGA) need surfactant, a medicine that helps the lungs. The goal of the study is to compare the use of video-based visualization to direct visualization during a procedure called less invasive surfactant administration (LISA). The main questions the study aims to answer are: 1) does one method of visualization have a increased rate of giving the medicine successfully on the first attempt? 2) what benefits are there of each method?

Participants needed: 100
Trial details
Age: 0-3Biological sex: AllType: InterventionalSponsor: University of Texas Southwestern Medical CenterUpdated: Jun 15, 2026Locations: 1
Eligibility criteria

Infants born ≤28 weeks GA successfully resuscitated in the delivery room (DR) an...

Infants born ≥29 weeks GA or [+3]

Status: Recruiting

Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes

Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation. This randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (\< 28 weeks).

Participants needed: 76
Trial details
Phase: Phase 4Age: 0-72Biological sex: AllType: InterventionalSponsor: Medical University of GrazUpdated: May 14, 2026Locations: 1
Eligibility criteria

Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days) [+2]

Invasive ventilation, indication of INSURE procedure [+2]

Status: Not yet recruiting

deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants

Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant replacement therapy. Surfactant replacement therapy is an established therapy for the treatment of respiratory distress syndrome, which is a common illness in infants born preterm. Surfactant replacement therapy can be delivered to an infant's lungs a few ways, including via a small tube that is briefly placed down an infant's throat. This is considered the least invasive method currently available, and is becoming more popular. It is referred to as minimally invasive surfactant therapy (MIST). A baby can receive surfactant via MIST if they are receiving non-invasive respiratory support, like from a continuous positive airway pressure (CPAP) machine. Doctors and researchers are looking for simple ways to make MIST more effective. This clinical trial will investigate if briefly increasing the air pressure delivered by a CPAP machine before giving MIST therapy will make MIST more effective. This strategy is called a lung recruitment manoeuvre (LRM), because it opens up more of the lungs - 'recruits' them - to help with oxygenation. The CPAP setting that is briefly changed is called positive end expiratory pressure (PEEP) - it increases the amount of air left in the lungs at the end of a breath. This stops parts of the lung collapsing when exhaling, which commonly occurs in the lungs of infants born preterm as they are immature. The goal of this clinical trial is to investigate if a LRM prior to MIST improves ventilation and lung aeration in preterm infants born 24-32 weeks' gestation. The main question it aims to answer is: How a LRM prior to MIST might impact patterns of ventilation and lung aeration in preterm infants, compared to no LRM prior to MIST. The current standard of care is no LRM before MIST. Researchers will compare this current standard against a LRM before MIST to see if it potentially improves patterns of ventilation. Participants will be randomly placed (by chance) to receive either no LRM before MIST (control) or a LRM before MIST (intervention). Participants will be randomised once their treating clinical team have decided to give MIST.

Participants needed: 36
Trial details
Age: 24-32Biological sex: AllType: InterventionalSponsor: Murdoch Childrens Research InstituteUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Born between 24 to 31+6 weeks' gestation, by best obstetric estimate [+7]

Receiving any form of respiratory support other than CPAP [+11]

Status: Recruiting

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are: Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique? Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant. Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will: Receive surfactant replacement therapy by the less invasive surfactant administration technique. Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.

Participants needed: 1,512
Trial details
Phase: Phase 4Age: 1-24Biological sex: AllType: InterventionalSponsor: Indiana UniversityUpdated: Mar 27, 2026Locations: 8
Eligibility criteria

Birth weight between 750 and 2000 grams or gestational age between 24- and 35 we... [+2]

Major congenital or genetic anomalies. [+2]

Status: Recruiting

Surfactant Administration by Insure or Thin Catheter

This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.

Participants needed: 160
Trial details
Age: Up to 2Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Jul 1, 2025Locations: 1
Eligibility criteria

Infants born before 32 completed weeks of gestation on CPAP, with clinical and r...

Infants requiring surfactant as part of delivery room resuscitation are not elig...

Status: Not yet recruiting

Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants

The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early. Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in. High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose. The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment. The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.

Participants needed: 245
Trial details
Age: 34-38Biological sex: AllType: InterventionalSponsor: King's College Hospital NHS TrustUpdated: May 22, 2024
Eligibility criteria

Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birt... [+1]

Infants requiring intubation at birth [+1]

Status: Recruiting

Premedication for Less Invasive Surfactant Administration

Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of "soft landing" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.

Participants needed: 40
Trial details
Phase: Phase 4Biological sex: AllType: InterventionalSponsor: University of OuluUpdated: Jun 5, 2023Locations: 1
Eligibility criteria

Gestational age at birth ≥26 weeks [+3]

Severe RDS with high oxygen requirements, severe respiratory acidosis and/or wid... [+3]