Respiratory Distress Syndrome, Newborn

13

Review clinical trials related to Respiratory Distress Syndrome, Newborn. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Fentanyl and Rocuronium for Tracheal Intubation in Newborns

Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates. This randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg/kg IV) to standard fentanyl premedication (1 mcg/kg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg/kg IV) is available as a reversal agent in case of prolonged neuromuscular blockade. A secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.

Participants needed: 102
Trial details
Phase: Phase 4Age: 1-28Biological sex: AllType: InterventionalSponsor: UEA - Universidade Do Estado Do AmazonasUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age <... [+2]

Upper airway malformations [+7]

Status: Recruiting

Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure

Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.

Participants needed: 52
Trial details
Age: 0-2Biological sex: AllType: InterventionalSponsor: Connecticut Children's Medical CenterUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

The infant's parent/legal guardian can understand and willingly sign a written i... [+2]

Unable to obtain lung ultrasound between 1-2 hours of life [+5]

Status: Not yet recruiting

Speed of Lung Inflation During Ventilation of Extremely Preterm Infants

Babies born extremely preterm (\<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. To reduce this damage, doctors and nurses take particular care to try and provide the gentlest breathing support possible. However, evidence is still required to determine how to best support babies' breathing, whilst preventing lung damage and longer-term lung problems. This clinical trial aims to compare two ways of adjusting a common setting on the breathing machine. This setting is called the pressure rise time or PRT. The PRT determines how quickly the breathing machine inflates a premature baby's lungs. A short PRT quickly inflates the lungs. A long PRT inflates the lungs more slowly. Previous research suggests that more slowly inflating the baby's lungs may cause less lung damage and still allow oxygen to be delivered to and carbon dioxide to be cleared from the lungs. However, larger studies are required to determine whether this should become the standard treatment. This study investigates whether inflating the baby's lungs more slowly (long PRT) using the breathing machine is as effective as the PRT setting currently used (short PRT, more quickly inflating the lungs). The main question it aims to answer is: Does how quickly the breathing machine inflates an extremely preterm baby's lung impact their oxygen levels?

Participants needed: 68
Trial details
Age: 6-7Biological sex: AllType: InterventionalSponsor: Murdoch Childrens Research InstituteUpdated: Jun 24, 2026Locations: 3
Eligibility criteria

Admitted to participating neonatal intensive care unit [+7]

Major congenital anomaly involving the cardiac, respiratory or gastrointestinal... [+3]

Status: Not yet recruiting

Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration

This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and late-preterm infants. The research will involve 100 infants, with 67 in the prospective group and 33 serving as controls. The primary goal is to shorten the time to treatment for these vulnerable newborns. The study will also assess whether this ultrasound-guided approach improves short-term respiratory outcomes. These secondary objectives include measuring any decrease in the need for and duration of mechanical ventilation, the length of non-invasive respiratory support, and the overall need for oxygen. The study population includes infants born between 27 and 34 6/7 weeks of gestation who are admitted to the NICU. Each participant will be monitored from birth until they are discharged or transferred. This research aligns with a growing body of evidence suggesting that lung ultrasound can be a valuable tool in neonatal care, potentially leading to earlier and more precise treatment for respiratory distress syndrome.

Participants needed: 100
Trial details
Age: 27-34Biological sex: AllType: InterventionalSponsor: Hackensack Meridian HealthUpdated: May 22, 2026Locations: 1
Eligibility criteria

Inborn at 27 0/7 to 34 6/7 weeks of gestational age [+2]

Outborn [+7]

Status: Recruiting

Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study

Many babies born very preterm (\<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs. To reduce this damage, doctors and nurses try to change babies to gentler breathing support that does not require a breathing tube. This is usually done using a method called nasal continuous positive airway pressure (nCPAP) that uses a nosepiece to deliver breaths. This process of removing the breathing tube is called "extubation". Many babies will need the breathing tube put back in after extubation (for various reasons) and this is independently associated with poorer outcomes. This research study aims to compare two ways of performing extubation - both of which are already used regularly by doctors and nurses. The "standard extubation" approach involves taking a baby's breathing tube out first, then applying the nosepiece and starting nCPAP. The more recent approach, called "prePAP", involves applying the nosepiece and starting nCPAP before taking the breathing tube out. Previous research suggests that a prePAP approach may provide better support for babies during extubation. However, larger studies are required before this approach is more commonly used. This study is investigating whether extubating the baby with prePAP is better than extubating the baby without prePAP. The main question it aims to answer is: Does initiating nCPAP before extubation in very preterm babies reduce the fall in their oxygen levels post-extubation?

Participants needed: 134
Trial details
Age: 0+Biological sex: AllType: InterventionalSponsor: Murdoch Childrens Research InstituteUpdated: May 19, 2026Locations: 2
Eligibility criteria

The infant is admitted to participating NICU [+5]

The infant is born <22 weeks or >30 weeks gestational age [+5]

Status: Recruiting

LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study

This prospective, non-randomized, unblinded pilot study evaluates and compares the intrapulmonary distribution of exogenous surfactant in preterm neonates when administered via Less Invasive Surfactant Administration (LISA) versus conventional endotracheal intubation (ETT). Lung ultrasound (LUS) will be utilized to assess the pioneer Surfactant Distribution Homogeneity Index (SDHI) to quantify the evenness and extent of surfactant-induced lung aeration. Secondary objectives include evaluating changes in LUS scores, short-term clinical respiratory outcomes, and feasibility parameters for guiding future larger-scale trials.

Participants needed: 22
Trial details
Age: 24-42Biological sex: AllType: InterventionalSponsor: Hamad General HospitalUpdated: Apr 7, 2026Locations: 1
Eligibility criteria

Not listed

Status: Recruiting

Evaluation of Serial Lung Ultrasound Data After Surfactant Treatments Applied With Different Methods in Preterm Babies

This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

Participants needed: 68
Trial details
Age: 1-5Biological sex: AllType: InterventionalSponsor: Konya City HospitalUpdated: Mar 31, 2026Locations: 1
Eligibility criteria

Infants of families who agree to participate in the study [+1]

Infants whose families did not provide consent [+2]

Status: Recruiting

Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting

The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (\>6 hours of life).

Participants needed: 500
Trial details
Age: 32-41Biological sex: AllType: ObservationalSponsor: Mayo ClinicUpdated: Mar 18, 2026Locations: 1
Eligibility criteria

Neonates born at 32 completed weeks gestational age or older whose deliveries ar... [+1]

Neonates with known or suspected congenital anomalies [+3]

Status: Recruiting

Prophylactic Minimally Invasive Surfactant Evaluation

The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?

Participants needed: 200
Trial details
Phase: Phase 4Age: Up to 15Biological sex: AllType: InterventionalSponsor: Endeavor HealthUpdated: Aug 7, 2025Locations: 1
Eligibility criteria

Gestational age <30 weeks [+1]

Congenital anomalies [+1]

Status: Not yet recruiting

Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant

The ULISSES study looks at how doctors use bedside ultrasound to help treat premature babies with breathing problems caused by Respiratory Distress Syndrome (RDS). It focuses on whether doctors decide to give a medicine called surfactant based on oxygen levels alone or if they also use lung ultrasound images to guide their decision. Around 200 babies will take part in the study in hospitals across Poland. Doctors will do ultrasound scans of the babies' lungs before and after surfactant is given. In some hospitals, heart and lung blood flow will also be checked to look for signs of high blood pressure in the lungs. The study will see if both lungs improve equally after treatment or if one side stays worse, and whether this affects how much breathing support the baby needs. The results may help doctors improve how and when they give surfactant, leading to better care for newborns with RDS.

Participants needed: 200
Trial details
Biological sex: AllType: ObservationalSponsor: Chiesi Poland Sp. z o.o.Updated: Jul 17, 2025Locations: 2
Eligibility criteria

Preterm neonates (gestational age <37 weeks) with established Respiratory Distre... [+1]

Presence of major congenital abnormalities of the respiratory system [+1]

Status: Not yet recruiting

An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.

This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly. The skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency. In the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today. The investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a "Just-in-Time" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a "Just-in-Time" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.

Participants needed: 140
Trial details
Age: Up to 1Biological sex: AllType: InterventionalSponsor: University College DublinUpdated: Mar 27, 2025Locations: 1
Eligibility criteria

Neonates with an upper airway malformation. [+1]

Status: Not yet recruiting

LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS

All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.

Participants needed: 150
Trial details
Biological sex: AllType: ObservationalSponsor: Andaluz Health ServiceUpdated: May 1, 2024Duration: 5 Years
Eligibility criteria

Infants born before 26 weeks at any of the participant hospitals.

received surfactant before LU [+3]

Status: Recruiting

European Management Platform for Childhood Interstitial Lung Diseases - chILD-EU Register and Biobank

Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of outcomes used in child Assess treatment variations used, deliver data from defined protocols and linked outcomes

Participants needed: 1,000
Trial details
Biological sex: AllType: ObservationalSponsor: Matthias GrieseUpdated: Sep 21, 2022Locations: 3Duration: 10 Years
Eligibility criteria

all children with suspected or [+3]

other indication as inclusion criteria