Clinical trial • Phase III • Respiratory

DOXAPRAM HYDROCHLORIDE MONOHYDRATE for Apnea of prematurity

Phase III trial of DOXAPRAM HYDROCHLORIDE MONOHYDRATE for Apnea of prematurity.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Apnea of prematurity
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
10-10-2024
First CTIS Authorization Date
11-11-2024

Trial design

Randomised, doxapram hydrochloride monohydrate (doxa) solution for infusion, intravenous; dosing units reported as mg/kg with max daily dose amount '48' (doseuom: mg/kg) and max total dose amount '2' (doseuomtotal: mg/kg/h). comparator: placebo: glucose 5% 50 ml.-controlled Phase III trial across 20 sites in Netherlands, Belgium.

Randomised
Yes
Comparator
Doxapram hydrochloride monohydrate (DOXA) solution for infusion, intravenous; dosing units reported as mg/kg with max daily dose amount '48' (doseUom: mg/kg) and max total dose amount '2' (doseUomTotal: mg/kg/h). Comparator: Placebo: Glucose 5% 50 ml.
Target Sample Size
300
Trial Duration For Participant
730

Eligibility

Recruits 300 paediatric patients.

Vulnerable Population
Trial population are preterm newborns (neonates). Consent is required from parents or legal representatives: "Written informed consent according to the national guidelines of both (the Netherlands) or at least one (Belgium and Canada) parent(s) or legal representatives". Neonates are a vulnerable population and cannot provide assent themselves; consent documents and processes are provided to parents/legal representatives and national/local rules are followed.

Inclusion criteria

  • {"criterion_text":"- Admitted to the NICU of one of the participating centres"}
  • {"criterion_text":"- Written informed consent according to the national guidelines of both (the Netherlands) or at least one (Belgium and Canada) parent(s) or legal representatives"}
  • {"criterion_text":"- Gestational age at birth < 29 weeks"}
  • {"criterion_text":"- Postnatal age of at least 120 hours"}
  • {"criterion_text":"- Caffeine therapy, adequately dosed"}
  • {"criterion_text":"- Optimal non-invasively respiratory support according to the local treatment policy (with nasal CPAP or ventilation ((S)NIPPV, BIPAP/Duopap, nasal HFO)"}
  • {"criterion_text":"- Frequent and/or severe apneas that require a medical intervention as judged by the attending physician"}

Exclusion criteria

  • {"criterion_text":"- Previous use of open label doxapram"}
  • {"criterion_text":"- Use of theophylline (to replace doxapram)"}
  • {"criterion_text":"- Chromosomal defects (e.g. trisomy 13, 18, or 21)"}
  • {"criterion_text":"- Major congenital malformations that: 1) Compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); 2) Result in chronic ventilation (e.g. Pierre Robin sequence), or 3) Increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities)"}
  • {"criterion_text":"- Palliative care or treatment limitations because of high risk of impaired outcome"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary outcome will be the composite outcome of death or severe disability at the age of 18-24 months corrected age. Both outcomes will also be analyzed seperately.","definition_or_measurement_approach":"Composite of death or severe disability at 18-24 months corrected age; both components (death and severe disability/neurodevelopmental impairment) will also be analysed separately. (No further measurement details provided in the record.)"}

Recruitment

Planned Sample Size
300
Recruitment Window Months
84
Consent Approach
Written informed consent is required from parents or legal representatives according to national guidelines: in the Netherlands consent from both parents; in Belgium and Canada consent from at least one parent or legal representative. Subject information and informed consent forms are provided (multiple versions including French available as indicated in the document list). Neonates cannot assent; consent is provided by parent(s)/legal representative(s).

Geography

Total Number Of Sites
20
Total Number Of Participants
300

Netherlands

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
7
Number Of Sites
10
Number Of Participants
200

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
IC Neonatology
Contact Person Name
S.H.P Simons
Site Name
Academisch Ziekenhuis Maastricht
Department Name
IC Neonatology
Contact Person Name
M. Hutten
Contact Person Email
matthias.hutten@mumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
IC Neonatology
Contact Person Name
P.H. Dijk
Contact Person Email
p.h.dijk@umcg.nl
Site Name
Maxima Medisch Centrum
Department Name
IC Neonatology
Contact Person Name
E. de Kort
Contact Person Email
e.dekort@mmc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
IC Neonatology
Contact Person Name
I.A. Zonnenberg
Contact Person Email
I.A.Zonnenberg-2@umcutrecht.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
IC Neonatology
Contact Person Name
W de Boode
Contact Person Email
Willem.DeBoode@radboudumc.nl
Site Name
Amsterdam UMC Stichting
Department Name
IC Neonatology
Contact Person Name
G.J. Hutten
Contact Person Email
g.j.hutten@amsterdamumc.nl
Site Name
Isala Klinieken Stichting
Department Name
IC Neonatology
Contact Person Name
M Hemels
Contact Person Email
m.a.c.hemels@isala.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
IC Neonatology
Contact Person Name
A. te Pas
Contact Person Email
A.B.te_Pas@lumc.nl
Site Name
Antwerp University Hospital
Department Name
IC Neonatology
Contact Person Name
Michiel Voeten
Contact Person Email
michiel.voeten@uza.be

Belgium

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
9
Number Of Sites
10
Number Of Participants
100

Sites

Site Name
Chirec
Department Name
Neonatology
Contact Person Name
Olivia Williams
Contact Person Email
brusselsdoc@gmail.com
Site Name
Ziekenhuis Aan De Stroom
Department Name
Neonatology
Contact Person Name
Katleen Plaskie
Contact Person Email
katleen.plaskie@gza.be
Site Name
Grand Hopital De Charleroi
Department Name
Neonatology
Contact Person Name
Vincent Cassart
Contact Person Email
vincent.cassart@ghdc.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Neonatology
Contact Person Name
Katherine Carkeek
Site Name
Ziekenhuis Oost Limburg
Department Name
Neonatology
Contact Person Name
Sarah Verbeeck
Contact Person Email
sarah.verbeeck@zol.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Neonatology
Contact Person Name
Luc Cornette
Contact Person Email
luc.cornette@azsintjan.be
Site Name
Antwerp University Hospital
Department Name
Neonatology
Contact Person Name
Michiel Voeten
Contact Person Email
michiel.voeten@uza.be
Site Name
UZ Leuven
Department Name
Neonatology
Contact Person Name
Anne Smits
Contact Person Email
anne.smits@uzleuven.be
Site Name
UZ Brussel
Department Name
Neonatology
Contact Person Name
Filip Cools
Contact Person Email
Filip.cools@uzbrussel.be
Site Name
Hopital Erasme
Department Name
Neonatology
Contact Person Name
Dorottya Kelen

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
DOXA (Doxapram hydrochloride monohydrate)
Active Substance
DOXAPRAM HYDROCHLORIDE MONOHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
max daily dose amount 48 (doseUom: mg/kg); max total dose amount 2 (doseUomTotal: mg/kg/h)
Investigational Product Name
Glucose 5% 50 ml (Placebo)
Modality
Other

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