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NCT06832163
Close Loop Smart Weaning for INO With PPHN
NA trial testing Nitric Oxide Generation and Delivery System in Persistent Pulmonary Hypertension of the Newborn in 30 participants. Not yet recruiting.
31 December 2026
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 March 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Nitric Oxide Generation and Delivery System
Conditions studied
- Persistent Pulmonary Hypertension of the Newborn — all drugs for Persistent Pulmonary Hypertension of the Newborn →
- Inhaled Nitric Oxide — all drugs for Inhaled Nitric Oxide →
Sponsor
Children's Hospital of Fudan University
Who can join
Eligibility, any sex, with Persistent Pulmonary Hypertension of the Newborn or Inhaled Nitric Oxide. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In contemporary clinical practice concerning the administration of inhaled nitric oxide (iNO) within neonatal intensive care units (NICUs), a stepwise reduction approach is frequently employed in accordance with established neonatal guidelines. Nonetheless, the comparative advantages of a linear reduction strategy-characterized by a gradual decrease in inhalation concentration-over the traditional stepwise method in terms of efficacy and safety have yet to be conclusively established. Furthermore, existing iNO delivery devices necessitate that healthcare professionals manually adjust parameters at intervals dictated by the patient's condition. This reliance on subjective clinical judgment often results in variability and a lack of standardization in the duration of the weaning process. Additionally, the protracted and intricate nature of the weaning procedure considerably heightens the workload for healthcare staff. Importantly, the development of a scientifically grounded, standardized, and real-time feedback mechanism for weaning may enhance clinical outcomes for patients and mitigate the risks associated with inappropriate weaning practices or inconsistent manual interventions. Consequently, this study seeks to leverage the newly introduced "intelligent closed-loop weaning" feature of the latest generation of iNO devices to facilitate automated linear concentration reduction during the weaning process. This innovation aims to alleviate the burden on healthcare personnel while establishing a more standardized and scientifically robust weaning protocol. However, it is noteworthy that there is currently a lack of clinical evidence, both domestically and internationally, regarding the safety and efficacy of this device's weaning protocol, underscoring the urgent need to validate its safety and effectiveness in real-world clinical settings.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06832163
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nitric Oxide Generation and Delivery System
Trials testing the same drug.
- NCT06852924 — Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE) · NA · recruiting
- NCT07382258 — A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease · NA · recruiting
- NCT05785195 — A Mechanistic Study of Inhaled Nitric Oxide in COPD · NA · unknown
Other recruiting trials for Persistent Pulmonary Hypertension of the Newborn
Currently open trials in the same condition.
- NCT04938167 — Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hyp · NA · active not recruiting
Other Children's Hospital of Fudan University trials
Trials by the same sponsor.
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- NCT05862688 — A Cohort Study on Anti-microbial Stewardship in PICU · not yet recruiting
- NCT05595239 — Blood Purification in Septic Children · NA · not yet recruiting
- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
- NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06832163 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Fudan University
- Last refreshed: 18 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06832163.
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