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apnea of prematurity - Clinical Profile, Treatments & Trials | Kisho | Kisho

Rare Disease

apnea of prematurity

MONDO:0020567

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Overview

Apnea of prematurity is a developmental disorder affecting premature infants, likely secondary to an immaturity of respiratory control resulting in idiopathic pauses in breathing often associated with reduced heart rate and arterial blood oxygen levels. It may be exacerbated by concurrent neonatal diseases.

Treatments1 FDA approved

Clinical Trials15 registered · 4 recruiting

Clinical Presentation

Built from Human Phenotype Ontology (HPO) phenotype annotations and GeneReviews clinical descriptions. Features represent findings documented across known cases — not an exhaustive list of possible symptoms.

Features include very common findings: Apnea; and common findings: Cyanosis, Bradycardia, and Low blood oxygen levels (hypoxemia). 5 total HPO annotations.

Organ System	Phenotype Count	Example Features
Lungs and breathing	2	Apnea, Low blood oxygen levels (hypoxemia)

Treatment

Compiled from FDA-approved drug records, orphan drug designations, and FDA Adverse Event Reporting System (FAERS) safety data. GeneReviews management guidance is included where available.

1 FDA-approved treatment is available for apnea of prematurity, including CAFFEINE CITRATE (CAFFEINE CITRATE, approved 1999). An additional 2 compounds hold orphan drug designation.

Approved Therapies

Brand Name	Generic Name	Mechanism	Approved	Market Status

Prognosis

Phenotype severity distribution: 1 very common feature, 3 common features.

Estimated prevalence: 1-9 in 100,000 (Uncommon).

Research Landscape

Sourced from ClinicalTrials.gov and PubMed. Publication types are classified using NLM-curated article metadata; research type breakdowns reflect the nature of published work for this disease.

15 clinical trials registered, 4 recruiting. Interventions under study include drug therapy, other interventions, and medical devices. Pipeline includes 2 PHASE4, 1 PHASE3, 1 PHASE2. Research is primarily sponsored by academic and government institutions.

NCT ID	Title	Phase	Sponsor	Status
[NCT06401083](https://clinicaltrials.gov/study/NCT06401083)

Data assembled from 6 of 12 sources · Last updated Sep 17, 2026, 9:52 PM UTC

MONDOHPOClinicalTrials.govFDAPubMedHGNCClinVarClinGenGeneReviewsOrphanetOMIMRUSP

Medical References

External Resources

Orphanet

European rare disease database

Orphanet:99981

GARD

Genetic and Rare Diseases Info Center

GARD:19722

Questions for Your Care Team

→What are the benefits and potential side effects of CAFFEINE CITRATE for managing apnea of prematurity?
→Are any of the 15 active clinical trials a good fit for my situation?
→Are there specialists or centers of excellence for this condition in my area?
→Is there a patient registry I should consider joining?

← Back to All Diseases

Brand Name	Generic Name	Sponsor	Designated	Exclusivity End	Designation Status
hydrogen sulfate salt is a white or off white crystalline powder with a molecular weight of 352.42 Da [C11H24N6O5S], prepared in a 1:1 ratio of sulfuric acid (MW 98.06 DA) and ENA-001 (free base; MW 254.36 Da [C11H22N6O].	hydrogen sulfate salt is a white or off white crystalline powder with a molecular weight of 352.42 Da [C11H24N6O5S], prepared in a 1:1 ratio of sulfuric acid (MW 98.06 DA) and ENA-001 (free base; MW 254.36 Da [C11H22N6O].	Enalare Therapeutics Inc.	2022	—	Designated
N-acetylcysteine	N-acetylcysteine	Galleon Pharmaceuticals	2010	—	Withdrawn

Research Type	Count	% of Total
Clinical study results	17	27%
Disease patterns and progression	16	25%
Research summaries	13	21%
Laboratory research	9	14%
Patient case studies	4	6%
Other research	2	3%
New treatment approaches	2	3%

Kisho

apnea of prematurity

Overview

Clinical Presentation

Treatment

Approved Therapies

Prognosis

Research Landscape

Medical References

External Resources

Orphanet

GARD

Questions for Your Care Team

Questions for Your Care Team

Explore clinical features

Orphan Drug Designations

Clinical Trials

Recent Publications

apnea of prematurity

Overview

Clinical Presentation

Treatment

Approved Therapies

Prognosis

Research Landscape

Medical References

External Resources

Orphanet

GARD

Related Diseases

Questions for Your Care Team

Questions for Your Care Team

Explore clinical features

Orphan Drug Designations

Clinical Trials

Recent Publications