Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04430790
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2020-01-08
Brief Title:
Doxapram Therapy in Preterm Infants DOXA Trial
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Doxapram Versus Placebo in Preterm Newborns An International Double Blinded Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Preterm infants often suffer from apnea of prematurity AOP a cessation of breathing due to immaturity of the respiratory system AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn especially the central nervous system In order to prevent oxygen shortage infants are treated with non-invasive respiratory support and caffeine Despite these treatments many preterm newborns still suffer from AOP and need invasive mechanical ventilation Although this will result in complete resolution of AOP invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome Restrictive invasive ventilation is therefore advocated nowadays in preterm infants Doxapram is a respiratory stimulant that has been administered off-label to treat AOP Doxapram as add-on treatment seems to be effective in treating AOP and to prevent invasive mechanical ventilation It is unclear if a preterm infant benefit from doxapram treatment on the longer term This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation and related lung disease and AOP related oxygen shortage and related impaired brain development
Detailed Description:
The main objective of the trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and neurodevelopmental impairmentsevere disability at 2 years corrected age as compared to placebo This multicenter double blinded randomized placebo-controlled superiority trial will be conducted in multiple neonatal intensive care units in the Netherlands and Belgium including 8 years follow-up After written informed-consent the patients will be randomized into the doxapram treatment group or the placebo treatment group Randomization will be stratified based on center and gestational age or 26 weeks
The participating departments include Dutch and Belgian Neonatal Intensive care units The units include both academic and non-academic level III and IV units that are specialized in the care for critically ill and preterm born infants Postnatal ages of patients at doxapram start vary from directly after birth up to months for the most-preterm born infants
Blinded continuous doxapram or placebo glucose 5 will be infused as long as needed Therapy is down titrated or stopped based on the patients condition If endotracheal intubation is needed study drug is stopped After extubation study drug may be restarted Switch to gastro-enteral administration is allowed if no iv-access is needed for other reasons Next to study drug infusion there will be no other study-related interventions All outcome variables are already collected as standard of care In a subset of patients doxapram plasma levels will be determined to validate the doxapram pharmacokinetic PK model Blood will only be collected during routine blood sampling with a maximum amount of 06 ml Economic and cost-effectiveness evaluation will be performed The national protocol for preterm birth advices follow-up at 2 55 and 8 years respectively as in the current study Additional questionnaires will be used to collect data on the quality of life of patients and their parents
The participating departments include Dutch and Belgian Neonatal Intensive care units The units include both academic and non-academic level III and IV units that are specialized in the care for critically ill and preterm born infants Postnatal ages of patients at doxapram start vary from directly after birth up to months for the most-preterm born infants
Blinded continuous doxapram or placebo glucose 5 will be infused as long as needed Therapy is down titrated or stopped based on the patients condition If endotracheal intubation is needed study drug is stopped After extubation study drug may be restarted Switch to gastro-enteral administration is allowed if no iv-access is needed for other reasons Next to study drug infusion there will be no other study-related interventions All outcome variables are already collected as standard of care In a subset of patients doxapram plasma levels will be determined to validate the doxapram pharmacokinetic PK model Blood will only be collected during routine blood sampling with a maximum amount of 06 ml Economic and cost-effectiveness evaluation will be performed The national protocol for preterm birth advices follow-up at 2 55 and 8 years respectively as in the current study Additional questionnaires will be used to collect data on the quality of life of patients and their parents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 80-84800-9843009 | OTHER_GRANT | None | None |
| 2019-003666-41 | EUDRACT_NUMBER | ZonMw GGG | None |