Open lung positive pressure ventilation in neonatal respiratory distress syndrome.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22682

Enrollment

Registered

2005-12-15

Start date

2006-01-09

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory distress syndrome (RDS), mechanical ventilation

Interventions

Patients will be randomized to receiving either open lung or conventional positive pressure ventilation. During open lung ventilation, collapsed alveoli will be actively recruited and stabilized with

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age between 27 0/7-34 0/7; 2. Postnatal age < 12 h; 3. Mechanical ventilation for RDS; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Small for gestational age (less than P3); 2. Persistent pulmonary hypertension; 3. Congenital malformations; 4. Severe septic shock; 5. Air leak syndrome; 6. Surfactant therapy prior to inclusion.

Design outcomes

Primary

Measure	Time frame
Oxygenation.	—

Secondary

Measure	Time frame
1. Time to extubation; 2. Incidence of air leaks; 3. Incidence of hypotension; 4. Incidence of treatment failure.	—

Contacts

Public ContactA.H.L.C. Kaam, van

Academic Medical Center (AMC), Emma Children's Hospital, Department of Neonatology (Room H3-150) P.O. Box 22660

a.h.vankaam@amc.uva.nl+31 (0)20 5663971

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)