Overview
Sponsor-declared trial summary
Prematurity
The null hypothesis for this study is that the incidence of mortality or abnormal neurodevelopmental outcomes at 18-24 months corrected age will be no different by using either higher initial oxygen concentration of 60% compared to using lower initial oxygen concentration of 30% for resuscitation of preterm infants of …
Key facts
- Sponsor
- University College Cork
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 9 Oct 2024 → ongoing
- Decision date (initial)
- 2024-05-03
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Canadian Institute of Health Research Foundation Grant (CIHR)
External identifiers
- EU CT number
- 2023-509780-25-00
- ClinicalTrials.gov
- NCT03825835
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
The null hypothesis for this study is that the incidence of mortality or abnormal neurodevelopmental outcomes at 18-24 months corrected age will be no different by using either higher initial oxygen concentration of 60% compared to using lower initial oxygen concentration of 30% for resuscitation of preterm infants of 23-28 weeks’ gestation.
Conditions and MedDRA coding
Prematurity
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Infants with gestational age between 23 to 28 weeks based on best available obstetrical estimate
- Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to forego resuscitation
- No known major congenital or chromosomal malformation.
Exclusion criteria 2
- Infant born outside of study centers and transported to center after delivery
- Parents’ refusal to give consent to this study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome is a composite between 18 and 24 months corrected age of all-cause mortality or the presence of a major neurodevelopmental outcome defined as any one of: (i) non-ambulatory cerebral palsy; (ii) severe cognitive delay, (iii) hearing impairment (requiring a hearing aid or cochlear implants), and (iv) visual (cannot fixate/ legally blind, or corrected acuity <6/60 in both eyes).
Secondary endpoints 4
- All-cause in-hospital mortality
- Severe brain injury, defined as Grade 3 and 4 IVH / intraparenchymal hemorrhage or echodense intraparenchymal lesions, periventricular leukomalacia, porencephalic cysts or ventriculomegaly on cranial ultrasound
- Bronchopulmonary dysplasia
- Severe retinopathy of prematurity (stage 3 or 4 or treated cases)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD404326 · Product
- Active substance
- Oxygen Ph.eur.
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 100 % percent
- Max total dose
- 100 % percent
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- PA 0208/003/001
- MA holder
- BOC GASES IRELAND LTD
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University College Cork
- Sponsor organisation
- University College Cork
- Address
- 6 Little Hanover Street
- City
- Cork
- Postcode
- T12 E30P
- Country
- Ireland
Scientific contact point
- Organisation
- University College Cork
- Contact name
- Muiris Dowling
Public contact point
- Organisation
- University College Cork
- Contact name
- Study Manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Ireland | Ongoing, recruiting | 65 | 1 |
| Rest of world
Canada
|
— | 1,185 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Ireland | 2024-10-09 | 2024-10-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 HiLo Protocol 2023-509780-25-00 | 3.8 |
| Protocol (for publication) | D1 Protocol_GSA_IRE_2023-509780-25-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_HiLo ICF_IE | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Medical Oxygen | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-21 | Ireland | Acceptable 2024-04-29
|
2024-05-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-01 | Ireland | Acceptable 2024-04-29
|
2024-10-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-10 | Ireland | Acceptable 2026-04-20
|
2026-04-20 |