Apnea of prematurity, respiratory insufficiency
Conditions
Interventions
Blinded continuous doxapram or placebo (glucose 5%) infusion as long as needed. Therapy is down titrated or stopped based on the patients’ condition. If endotracheal intubation is needed study drug is
Sponsors
Erasmus University Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: - Admitted to the NICU of one of the participating centres - Written informed consent of both parents or legal representatives - Gestational age at birth < 29 weeks - Caffeine therapy, adequately dosed - Optimal non-invasively supported according to the local treatment policy (with nasal CPAP or ventilation ((S)NIPPV, NIV-NAVA, BIPAP/Duopap, SIPAP) - Apnea that require a medical intervention as judged by the attending physician
Exclusion criteria
Exclusion criteria: - previous use of open label doxapram - use of theophylline (to replace doxapram) - chromosomal defects (e.g. trisomy 13, 18, or 21) - major congenital malformations that: compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); result in chronic ventilation (e.g. Pierre Robin sequence); increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities); palliative care or treatment limitations because of high risk of impaired outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death or severe disability at the age of 2 years corrected age. Disability will be defined as 1 or more of the following: - cognitive delay - cerebral palsy - severe hearing loss - bilateral blindness | — |
Secondary
| Measure | Time frame |
|---|---|
| - BPD at 36 weeks post menstrual age - Death at the age of 36 weeks post menstrual age and at hospital discharge - Short term neonatal co-morbidity : Incidence of endotracheal intubations after start study medication; number of days on invasive ventilation; number of days on ventilatory support; number of days with supplemental oxygen; length of stay on the intensive care; cumulative number of apnea , number of incidents associated with bradycardia; incidence of late onset sepsis; solitary intestinal perforation; necrotizing enterocolitis > stage 2 according to Bell; IVH; PVL; Growth, length, head circumference at 36 weeks PMA; retinopathy of prematurity - Additional long term outcome at 2 years corrected age; readmissions since first discharge home; weight, length and head circumference at 24 months; behavioral problems - Parent reported outcome with the PARCA-R questionnaire - Long term follow-up until the age of 5.5 and 8 years to determine long term effects on neurodevelopment , health, quality of life. - Adverse-effects and potential adverse drug reactions will be monitored and analyzed. | — |
Contacts
Public ContactSinno Simons
Erasmus MC - Sophia
Outcome results
None listed