Doxapram Therapy in Preterm Infants (DOXA Trial)

Launched by ERASMUS MEDICAL CENTER · Jun 11, 2020

Keywords

ClinConnect Summary

The DOXA Trial is studying a medication called doxapram to see if it can help preterm infants who are experiencing apnea of prematurity (AOP), which is when they temporarily stop breathing. AOP can lead to serious issues like low oxygen levels and slow heart rates, which can affect a baby’s growth and brain development. Currently, preterm infants are treated with supportive breathing methods and caffeine, but some still need more invasive treatments that can cause long-term lung problems. The researchers are comparing doxapram to a placebo (a treatment that looks like doxapram but has no active ingredients) to find out if doxapram can reduce the need for these invasive treatments and improve long-term health outcomes for these babies.

To participate in the trial, infants must be less than 29 weeks old at birth and admitted to a neonatal intensive care unit (NICU) with ongoing breathing challenges that require medical attention. Parents or legal guardians will need to give written consent for their child to be involved. If enrolled, participants can expect close monitoring while receiving either doxapram or a placebo, helping researchers learn more about the best ways to support the health of preterm infants experiencing AOP.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Admitted to the neonatal intensvie care unit (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 (see also under co-medication)
• • Optimal Non-invasively supported with nasal Continuous Positive Airway Pressure (CPAP) or ventilation ((S)NIPPV, NIV-NAVA, BIPAP/Duopap, SIPAP)
• • Apnea that require a medical intervention as judged by the attending physician
• 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.