Condition: PreTerm Neonate · Sedation for Invasive Mechanical Ventilation · Sponsor: Assistance Publique - Hôpitaux de Paris
Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency. In France, around 8,250 infants are born annually at \<32 weeks, with an estimated 5,000 needing IMV. Although non-invasive support such as continuous positive airway pressure (CPAP) has become more common, a substantial proportion of these neonates still transition to IMV within the first few days of life. To reduce lung injury and the incidence of bronchopulmonary dysplasia (BPD), a key strategy in neonatal intensive care involves limiting the duration of IMV and promoting earlier extubation. However, effective sedation and analgesia are essential for preterm infants subjected to intubation and mechanical ventilation. Traditionally, neonatologists combine a sedative (frequently midazolam) with an opioid (morphine, fentanyl, or sufentanil). Although these agents control pain and distress, they may cause respiratory depression, complicate weaning, and potentially contribute to adverse long-term outcomes. Midazolam, one of the few sedatives authorized for use in neonates, can improve comfort and sedation scores, but concerns persist about hypotension, altered cerebral perfusion, and a possible link to intraventricular hemorrhage (IVH). Moreover, combining benzodiazepines and opioids can prolong ventilation, increase the risk of complications, and impede timely extubation. Rationale for Dexmedetomidine (DEX) Dexmedetomidine (DEX) is …
This description comes directly from the study's public registry record.
Clément CHOLLAT, MD, PhD, Associate Professor · +33 6 86 72 29 58 · clement.chollat@aphp.fr
Stéphane MARRET, MD, PhD, Associate Professor · +33 2 32 88 64 22 · stephane.marret@chu-rouen.fr
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| Hospital Armand Trousseau, APHP Service : Department of Neonatology | Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06878703