Neonatal acute respiratory distress syndrome

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ORPHA:217563OMIM:265120P28.0
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2FDA treatments5Active trials50Specialists8Treatment centers

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

Neonatal acute respiratory distress syndrome (neonatal ARDS), also known as neonatal respiratory distress syndrome (NRDS), hyaline membrane disease, or surfactant deficiency disorder, is a serious breathing condition that primarily affects premature infants. It occurs when the lungs have not produced enough surfactant — a mixture of lipids and proteins that lines the alveoli (tiny air sacs) and prevents them from collapsing during breathing. Without adequate surfactant, the alveoli collapse with each breath, making gas exchange extremely difficult and leading to progressive respiratory failure. The condition predominantly affects the pulmonary system but can secondarily impact multiple organ systems due to hypoxemia (low blood oxygen levels), including the brain, heart, and kidneys. Key clinical features appear shortly after birth and include rapid, labored breathing (tachypnea), grunting respirations, nasal flaring, chest wall retractions (visible sinking of the skin between and below the ribs), and cyanosis (bluish discoloration of the skin). Chest X-rays characteristically show a diffuse reticulogranular (ground-glass) pattern with air bronchograms. The severity of the condition is closely related to the degree of prematurity, with infants born before 28 weeks of gestation being at highest risk. The treatment landscape has improved dramatically over the past several decades. Antenatal corticosteroids (given to the mother before preterm delivery) accelerate fetal lung maturation and surfactant production. Postnatal treatment includes exogenous surfactant replacement therapy administered directly into the lungs via the trachea, which has significantly reduced mortality. Supportive care includes supplemental oxygen, continuous positive airway pressure (CPAP), and mechanical ventilation when necessary. Despite advances in treatment, neonatal ARDS remains a leading cause of morbidity and mortality in premature infants, and survivors may be at risk for bronchopulmonary dysplasia and long-term respiratory complications.

Also known as:

Clinical phenotype terms— hover any for plain English:

Intraalveolar phospholipid accumulationHP:0006517Abnormal pulmonary interstitial morphologyHP:0006530Pulmonary opacityHP:0031457Right ventricular hypertrophyHP:0001667Spontaneous neonatal pneumothoraxHP:0004876Interstitial pneumonitisHP:0006515Chronic lung diseaseHP:0006528
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
Apr 2026Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure

Medical College of Wisconsin — NA

TrialNOT YET RECRUITING
Jan 2026Effect of L-Carnitine Supplementation in Preterm Neonates

Muhammad Aamir Latif — NA

TrialRECRUITING
Sep 2025Open-label Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome Admitted in the NICU of Mansoura University Children Hospital

Mansoura University Children Hospital — NA

TrialRECRUITING
Jul 2025Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome

Tanta University

TrialRECRUITING
May 2025Respiratory Distress and Elective Cesarean Section at Term

Assiut University

TrialRECRUITING
Mar 2025Neonatal Oximeter Bias Study

Czech Technical University in Prague

TrialNOT YET RECRUITING
Jan 2025InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

ONY — PHASE3

TrialRECRUITING
Aug 2024Transference of Established Simulated Skills (TEST) Trial

University of Texas Southwestern Medical Center

TrialACTIVE NOT RECRUITING
Jun 2024Misoprostol Before Caesarean Section

Kafrelsheikh University — PHASE4

TrialRECRUITING
May 2024Lung Ultrasound in Neonatal Intensive Care Units

Assiut University

TrialNOT YET RECRUITING

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

Treatments

2 available

Exosurf Neonatal for Intratracheal Suspension

Colfosceril palmitate, cetyl alcohol, tyloxapol· Glaxo Wellcome Inc.

Prevention of hyaline membrane disease (HMD) in infants born at 32 weeks gestation or less

Infasurf

calfactant· ONY Biotech Inc.Orphan Drug

Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.

Clinical Trials

5 recruitingView all trials with filters →
Phase 41 trial
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Phase 4
Actively Recruiting
· Sites: Evanston, Illinois
N/A1 trial
Effect of L-Carnitine Supplementation in Preterm Neonates
N/A
Actively Recruiting
PI: Muhammad Sarfraz, FCPS (Recep Tayyip Erdogan Hospital, Muzaffargarh) · Sites: Muzaffargarh, Punjab Province
Other3 trials
The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress
Actively Recruiting
· Sites: Bursa
Respiratory Distress and Elective Cesarean Section at Term
Actively Recruiting
· Sites: Asyut · Age: 2039 yrs
Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome
Actively Recruiting
· Sites: Tanta, El-Gharbia

Specialists

Showing 25 of 50View all specialists →
SM
Steven Simonson, MD
ELK GROVE, CA
Specialist
PI on 1 active trial
AM
Axel R Franz, MD
Specialist
PI on 1 active trial1 Neonatal acute respiratory distress syndrome publication
WM
William A. Carey, MD
Specialist
PI on 1 active trial1 Neonatal acute respiratory distress syndrome publication
BM
Beena G. Sood, MD, MS
DETROIT, MI
Specialist
PI on 1 active trial
KP
Kenneth Poole
GREENSBORO, NC
Specialist
PI on 1 active trial5 Neonatal acute respiratory distress syndrome publications
HM
Howard Clark, MBBS
PUYALLUP, WA
Specialist
PI on 1 active trial
JP
Joao Guilherme B Alves, PhD
Specialist
PI on 1 active trial
FP
Filip Cools, PhD
Specialist
PI on 1 active trial
AM
Arūnas Liubšys, MD
Specialist
PI on 1 active trial1 Neonatal acute respiratory distress syndrome publication
JM
Julie Lefevere, MD
Specialist
PI on 1 active trial
ŞM
Şebnem Çalkavur, MD
Specialist
PI on 1 active trial
MF
Muhammad Sarfraz, FCPS
Specialist
PI on 1 active trial
AF
Athar Razzaq, FCPS
Specialist
PI on 1 active trial
JM
Javier Rodríguez-Fanjul, M.D.
Specialist
PI on 1 active trial
PM
Pinchi Srinivasan, MD
FLUSHING, NY
Specialist
PI on 1 active trial
DL
Daniele De Luca
CA
Specialist
5 Neonatal acute respiratory distress syndrome publications
LC
Long Chen
Specialist
5 Neonatal acute respiratory distress syndrome publications
BL
Barbara Loi
Specialist
3 Neonatal acute respiratory distress syndrome publications
DT
David G Tingay
Specialist
2 Neonatal acute respiratory distress syndrome publications

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

Travel Grants

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

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Neonatal acute respiratory distress syndrome

Disease timeline:

New recruiting trial: PRICO: OPTI Target Range

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

New recruiting trial: Premedication for Less Invasive Surfactant Administration

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

New recruiting trial: Misoprostol Before Caesarean Section

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

New recruiting trial: Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome

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

New recruiting trial: Respiratory Distress and Elective Cesarean Section at Term

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

New recruiting trial: The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress

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

New recruiting trial: Effect of L-Carnitine Supplementation in Preterm Neonates

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

New recruiting trial: Non Inferiority Trial Investigating Surfactants Administered Via MIST

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

New recruiting trial: InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

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

New recruiting trial: Open-label Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome Admitted in the NICU of Mansoura University Children Hospital

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

Caregiver Resources

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

Common questions about Neonatal acute respiratory distress syndrome

What is Neonatal acute respiratory distress syndrome?

Neonatal acute respiratory distress syndrome (neonatal ARDS), also known as neonatal respiratory distress syndrome (NRDS), hyaline membrane disease, or surfactant deficiency disorder, is a serious breathing condition that primarily affects premature infants. It occurs when the lungs have not produced enough surfactant — a mixture of lipids and proteins that lines the alveoli (tiny air sacs) and prevents them from collapsing during breathing. Without adequate surfactant, the alveoli collapse with each breath, making gas exchange extremely difficult and leading to progressive respiratory failure

How is Neonatal acute respiratory distress syndrome inherited?

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

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

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

Are there clinical trials for Neonatal acute respiratory distress syndrome?

Yes — 5 recruiting clinical trials are currently listed for Neonatal 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 Neonatal acute respiratory distress syndrome?

25 specialists and care centers treating Neonatal 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 Neonatal acute respiratory distress syndrome?

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