Respiratory distress syndrome in premature infants

Summary

Respiratory distress syndrome in premature infants (MONDO:0009971) is a disease and 281 clinical trials. Top therapeutic interventions include betamethasone, calfactant, and poractant alfa. A subtype of newborn respiratory distress syndrome — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Clinical trials: 281

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	respiratory distress syndrome in premature infants
Mondo ID	MONDO:0009971
MeSH	C566881
OMIM	267450
Orphanet	70587
ICD-11	343716587
UMLS	C1968593
MedGen	368840
GARD	0000112
NORD	1659
Is cancer (heuristic)	no

Also known as: hyaline Membrane disease · infantile respiratory distress syndrome · IRDS · NRDS · RDS · RDS - infants · RDS of prematurity · respiratory distress syndrome · respiratory distress syndrome in premature infants · Respiratory Distress Syndrome, Infant · respiratory distress syndrome, infant

Disease family

This is a subtype of newborn respiratory distress syndrome. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by body system or component › respiratory system disorder › lower respiratory tract disorder › lung disorder › interstitial lung disease › interstitial lung disease specific to childhood › primary interstitial lung disease specific to childhood › newborn respiratory distress syndrome › respiratory distress syndrome in premature infants

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

No druggable-target or therapeutic data for this disease’s cohort.

Clinical trials & evidence

Clinical trials

Clinical trials: 281.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	201
PHASE4	24
PHASE3	22
PHASE2	16
PHASE1	8
PHASE2/PHASE3	7
PHASE1/PHASE2	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06074380	PHASE4	RECRUITING	Non Inferiority Trial Investigating Surfactants Administered Via MIST
NCT06554522	PHASE4	RECRUITING	Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
NCT07350018	PHASE4	RECRUITING	Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
NCT00146497	PHASE4	TERMINATED	Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants
NCT00277030	PHASE4	UNKNOWN	Two Strategies of RDS Treatment in Newborns With Birth Weight > 1500 Grams
NCT00295464	PHASE4	TERMINATED	Antenatal Rescue Course of Glucocorticoids in Threatened Premature Birth
NCT00368680	PHASE4	UNKNOWN	Early CPAP in Respiratory Distress Syndrome
NCT00391105	PHASE4	COMPLETED	Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
NCT00767039	PHASE4	TERMINATED	Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
NCT00797160	PHASE4	UNKNOWN	Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)
NCT00883532	PHASE4	UNKNOWN	Prevention of Chronic Lung Disease (CLD) in Preterm Infants
NCT01374061	PHASE4	WITHDRAWN	Pre Hospital Evaluation of Video Laryngoscopy
NCT01749501	PHASE4	COMPLETED	Premedication for Non-Emergency Endotracheal Intubation In the NICU
NCT01923844	PHASE4	COMPLETED	Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide
NCT02348047	PHASE4	TERMINATED	(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation
NCT02887924	PHASE4	UNKNOWN	SLI MANEUVER and RESPIRATORY MORBIDITIES
NCT03275415	PHASE4	COMPLETED	Intratracheal Budesonide/Surfactant Prevents BPD
NCT03366584	PHASE4	UNKNOWN	The Effect of β-Carotene, Vitamin D3 and Zinc on Hyaline Membrane Disease and Feeding Intolerance in Premature Neonates
NCT03521063	PHASE4	UNKNOWN	Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
NCT04073173	PHASE4	UNKNOWN	Stress Assessment With and Without Analgesia During Surfactant Therapy in Preterm Infants.
NCT04199364	PHASE4	UNKNOWN	Medium vs Low Oxygen Threshold for the Surfactant Administration
NCT04334629	PHASE4	WITHDRAWN	LIBERATE Trial in COVID-19
NCT05714865	PHASE4	COMPLETED	Implementing LISA Surfactant in Nigeria
NCT05758597	PHASE4	UNKNOWN	Sedative Effect and Safety of Remimazolam Besylate in ARDS Patients
NCT04545866	PHASE3	ACTIVE_NOT_RECRUITING	The Budesonide in Babies (BiB) Trial
NCT05960929	PHASE3	RECRUITING	InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
NCT06776783	PHASE3	RECRUITING	Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
NCT00000563	PHASE3	COMPLETED	Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration
NCT00000567	PHASE3	COMPLETED	High Frequency Ventilation in Premature Infants (HIFI)
NCT00000570	PHASE3	COMPLETED	Human Surfactant Treatment of Respiratory Distress Syndrome Bicenter Trial
NCT00000576	PHASE3	COMPLETED	Inhaled Beclomethasone to Prevent Chronic Lung Disease
NCT00004778	PHASE3	COMPLETED	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
NCT00005774	PHASE3	TERMINATED	Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
NCT00005777	PHASE3	TERMINATED	Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
NCT00016523	PHASE3	TERMINATED	Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
NCT00356668	PHASE3	COMPLETED	Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
NCT00563641	PHASE3	COMPLETED	Very Early Surfactant and NCPAP for Premature Infants With RDS
NCT00637507	PHASE2/PHASE3	COMPLETED	Study of a Novel Technique of Mechanical Ventilation in Patients With Severe Acute Respiratory Failure
NCT01222247	PHASE3	COMPLETED	Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
NCT01265589	PHASE3	UNKNOWN	Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
BETAMETHASONE	4	10
CALFACTANT	4	7
PORACTANT ALFA	4	6
BUDESONIDE	4	3
BERACTANT	4	2
CAFFEINE CITRATE	4	2
PROTIRELIN	4	2
BECLOMETHASONE DIPROPIONATE	4	1
BETA CAROTENE	4	1
ILOPROST	4	1
LUCINACTANT	4	1
NITRIC OXIDE	4	1
NITROGEN	4	1
PROPOFOL	4	1
REMIFENTANIL	4	1
RETINOL	4	1
ROCURONIUM	4	1
WATER	4	1
VASOACTIVE INTESTINAL PEPTIDE	3	1
ZINC ION	3	1
BECLOMETHASONE	2	1
CHEMBL249466	0	3
CHEMBL4067090	0	1
CHEMBL1201279	0	1