Infant acute respiratory distress syndrome

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ORPHA:70587OMIM:267450P22.0
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3FDA treatments12Active trials100Specialists8Treatment centers1Financial resources

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Infant acute respiratory distress syndrome (infant ARDS), also known as neonatal respiratory distress syndrome (RDS) or hyaline membrane disease, is a serious breathing condition that affects newborn babies, especially those born prematurely. In this condition, the tiny air sacs in the lungs (called alveoli) do not work properly because the lungs lack enough of a slippery substance called surfactant. Surfactant normally helps keep the air sacs open so that oxygen can pass into the blood. Without enough surfactant, the air sacs collapse with each breath, making it very hard for the baby to breathe. Babies with this condition breathe very fast, make grunting sounds, and their skin may turn bluish because they are not getting enough oxygen. The chest may look like it is caving in with each breath. Symptoms usually appear within minutes to hours after birth and can get worse over the first two to three days. Treatment has improved dramatically over the past few decades. Doctors can give surfactant directly into the baby's lungs through a breathing tube, which often leads to rapid improvement. Babies may also need help breathing from a machine (mechanical ventilator) or a gentler form of breathing support called CPAP. With modern neonatal intensive care, many babies recover fully, though very premature infants may face longer-term lung challenges.

Also known as:

Key symptoms:

Very fast breathing (more than 60 breaths per minute)Grunting sound with each breathBluish color of the skin, lips, or fingernails (called cyanosis)Nostrils flaring wide open with each breathChest pulling inward or 'caving in' with each breathLow oxygen levels in the bloodDifficulty feeding due to breathing problemsPale or mottled skin colorWeak cryLimpness or poor muscle tone

Inheritance

Multifactorial

Caused by a mix of several genes and environmental factors

Age of Onset

Neonatal

Begins at or shortly after birth (first 4 weeks)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Jul 2026ADINA vs. High Flow Nasal Cannula Comparison Study

Loma Linda University — NA

TrialNOT YET RECRUITING
Jun 2026Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants

University of Texas Southwestern Medical Center — NA

TrialNOT YET RECRUITING
Apr 2026Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery

The Children's Hospital of Zhejiang University School of Medicine — PHASE4

TrialNOT YET RECRUITING
Mar 2026Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting

Mayo Clinic

TrialRECRUITING
Mar 2026Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates

Neola Medical Inc — NA

TrialNOT YET RECRUITING
Mar 2026Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration

Hackensack Meridian Health — NA

TrialNOT YET RECRUITING
Feb 2026Speed of Lung Inflation During Ventilation of Extremely Preterm Infants

Murdoch Childrens Research Institute — NA

TrialNOT YET RECRUITING
Jan 2026Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome

Uludag University — PHASE4

TrialNOT YET RECRUITING
Jan 2026Early Surfactant Administration at FiO₂ >0.25 Under NIPPV for RDS in Very Preterm Infants

Jiulongpo No.1 People's Hospital — NA

TrialNOT YET RECRUITING
Dec 2025Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes

Medical University of Graz — PHASE4

TrialNOT YET RECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

3 available

Infasurf

calfactant· ONY Biotech Inc.

to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS

Curosurf

Pulmonary surfactant replacement, porcine· Chiesi USA, Inc.Orphan Drug

Treatment (rescue) of respiratory distress syndrome in premature infants.

Survanta intratracheal suspension

Beractant· Ross LaboratoriesOrphan Drug

Treatment of ("rescue") of premature infants with RDS confirmed by x-ray and requiring mechanical ventilation

Clinical Trials

12 recruitingView all trials with filters →
Phase 31 trial
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Phase 3
Actively Recruiting
· Sites: Little Rock, Arkansas; Jacksonville, Florida +7 more
Phase 11 trial
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
Phase 1
Actively Recruiting
· Sites: Cairo
N/A6 trials
High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial
N/A
Actively Recruiting
· Sites: Chongqing, Chongqing Municipality
To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation
N/A
Enrolling by Invitation
· Sites: Henan, Zhengzhou · Age: 2632 yrs
A Stepped Wedge Cluster Randomised Trial of Video Versus Direct Laryngoscopy for Intubation of Newborn Infants
N/A
Actively Recruiting
· Sites: Rijeka; Zagreb +16 more
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
N/A
Actively Recruiting
· Sites: Haifa
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants
N/A
Actively Recruiting
PI: André Kidszun, Prof. Dr. med. (Division of Neonatology, Department of Pediatrics,) · Sites: Mainz, Rhineland-Palatinate; Bern
Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
N/A
Actively Recruiting
PI: Daniel Lu, MD, PhD (University of California, Los Angeles) · Sites: Los Angeles, California · Age: 1899 yrs
Other4 trials
Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
Actively Recruiting
PI: Nicole Spillane (Hackensack Meridian Health) · Sites: Hackensack, New Jersey
Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
Actively Recruiting
· Sites: Chongqing, Chongqing Municipality
Predicting the Need for Prolonged Respiratory Support in Neonates Delivered in a Lower-Level NICU Setting
Actively Recruiting
PI: William A. Carey, MD (Mayo Clinic) · Sites: Rochester, Minnesota
A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
Actively Recruiting
PI: Colm P.F. O'Donnell, MB PhD (National Maternity Hospital, Dublin, Ireland) · Sites: Rijeka; Zagreb +14 more

Specialists

Showing 25 of 100View all specialists →
YS
Yuan Shi
Specialist
PI on 3 active trials
AM
Axel R Franz, MD
Specialist
PI on 1 active trial1 Infant acute respiratory distress syndrome publication
WM
William A. Carey, MD
Specialist
PI on 1 active trial1 Infant acute respiratory distress syndrome publication
BM
Beena G. Sood, MD, MS
DETROIT, MI
Specialist
PI on 1 active trial
GP
Guillaume Emeriaud, MD PhD
Specialist
PI on 1 active trial
KP
Kenneth Poole
GREENSBORO, NC
Specialist
PI on 1 active trial5 Infant acute respiratory distress syndrome publications
MM
Mario A Rojas, MD, MPH
Specialist
PI on 3 active trials
HM
Howard Clark, MBBS
PUYALLUP, WA
Specialist
PI on 1 active trial
JP
Joao Guilherme B Alves, PhD
Specialist
PI on 1 active trial
YP
Yves Ville, MD, PhD
Specialist
PI on 2 active trials
FP
Filip Cools, PhD
Specialist
PI on 1 active trial
JM
Julie Lefevere, MD
Specialist
PI on 1 active trial
AM
Arūnas Liubšys, MD
Specialist
PI on 1 active trial1 Infant acute respiratory distress syndrome publication
ŞM
Şebnem Çalkavur, MD
Specialist
PI on 1 active trial
JM
Javier Rodríguez-Fanjul, M.D.
Specialist
PI on 1 active trial
FP
Francesco Cresi, MD, PhD
Specialist
PI on 2 active trials
PM
Pinchi Srinivasan, MD
FLUSHING, NY
Specialist
PI on 1 active trial
MM
Michael Dunn, MD
Specialist
PI on 3 active trials

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Financial Resources

1 resources
Curosurf(Pulmonary surfactant replacement, porcine)Chiesi USA, Inc.

Travel Grants

No travel grants are currently matched to Infant acute respiratory distress syndrome.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Infant acute respiratory distress syndrome

Disease timeline:

New recruiting trial: Preterm Lung Patient Registry

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe ARDS

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: Feasibility of Using the Neovent in Low-Resource Settings

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

New recruiting trial: 30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants

A new clinical trial is recruiting patients for Infant acute respiratory distress syndrome

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.How severe is my baby's RDS, and what does that mean for their recovery?,Will my baby need a breathing machine, and for how long?,What are the chances my baby will develop long-term lung problems like bronchopulmonary dysplasia?,Should my baby be tested for a genetic cause of surfactant deficiency?,What signs should I watch for at home that would mean I need to call for emergency help?,Will my baby need any special follow-up for developmental delays?,Are there any vaccines or medications my baby will need to protect their lungs after going home?

Common questions about Infant acute respiratory distress syndrome

What is Infant acute respiratory distress syndrome?

Infant acute respiratory distress syndrome (infant ARDS), also known as neonatal respiratory distress syndrome (RDS) or hyaline membrane disease, is a serious breathing condition that affects newborn babies, especially those born prematurely. In this condition, the tiny air sacs in the lungs (called alveoli) do not work properly because the lungs lack enough of a slippery substance called surfactant. Surfactant normally helps keep the air sacs open so that oxygen can pass into the blood. Without enough surfactant, the air sacs collapse with each breath, making it very hard for the baby to brea

How is Infant acute respiratory distress syndrome inherited?

Infant acute respiratory distress syndrome follows a multifactorial inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Infant acute respiratory distress syndrome typically begin?

Typical onset of Infant acute respiratory distress syndrome is neonatal. Age of onset can vary across affected individuals.

Are there clinical trials for Infant acute respiratory distress syndrome?

Yes — 12 recruiting clinical trials are currently listed for Infant acute respiratory distress syndrome on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Infant acute respiratory distress syndrome?

25 specialists and care centers treating Infant acute respiratory distress syndrome are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Infant acute respiratory distress syndrome?

3 patient support programs are currently tracked on UniteRare for Infant acute respiratory distress syndrome. See the treatments and support programs sections for copay assistance, eligibility, and contact details.