Doxapram Therapy in Preterm Infants (DOXA Trial)

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).

Conditions

• Apnea of Prematurity
• Respiratory Insufficiency

Interventions

DRUG

Doxapram

Loading dose and continuous doxapram infusion.

DRUG

Placebo

Loading dose and continuous placebo infusion.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Nederlands Neonataal Netwerk (N3), the Netherlands

  collaborator UNKNOWN

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Maternal, Infant, Child and Youth Research Network (MICYRN)

  collaborator UNKNOWN

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Anne Smits, MD, PhD · Universitair Ziekenhuis Leuven

• Karel Allegaert, MD, PhD · Universitair Ziekenhuis Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

29 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-15

Primary Completion

2026-05-01

Completion

2034-05-01

Countries

• Belgium
• Canada
• Netherlands

Study Locations